Noted This Week - 2012 Archive
Archive of cancer-related news briefs, by week, for 2012
December 27, 2012
- Beset by controversy and the subject of a criminal investigation by the Texas attorney general's office, the Cancer Prevention and Research Institute of Texas has suspended new grants.
- A study of 12.2 million people whose parents were diagnosed with cancer has shown that familial risk increased significantly for colorectal, lung, breast, prostate, and bladder cancer; melanoma; skin squamous cell carcinoma, and non-Hodgkin lymphoma, even if parents were as old as 89 when they were diagnosed. The work, covering all Swedes born after 1931 and their biological parents, was published in the BMJ.
- Spectrum Pharmaceuticals of Henderson, NV, said that its belinostat, a pan-histone deacetylase (HDAC) inhibitor, surpassed an objective response rate of 20%, the primary efficacy endpoint, in relapsed/refractory peripheral T-cell lymphoma patients in the phase III BELIEF clinical trial.
- Moffitt Cancer Center of Tampa and Florida Blue of Jacksonville, FL, agreed to create a joint accountable care program for cancer treatment that will begin in 2013. Florida Blue and the Moffitt Medical Group, which includes 330 oncology practitioners in Florida, will focus on common cancers.
- Lifetime cancer risk will climb from 44% to 50% for men in the U.K. and from 40% to 44% for women in the U.K. by 2027, according to Cancer Research UK projections.
- Sutro Biopharma of San Francisco, CA, signed a deal with Celgene of Summit, NJ, to develop antibody–drug conjugates and bispecific antibodies for cancer, using Sutro's cell-free protein synthesis technology. The deal potentially could be worth more than $500 million, Sutro said.
December 20, 2012
- "Cancers claimed 8.0 million lives in 2010, 15.1% of all deaths worldwide, with large increases [since 1990] in deaths from trachea, bronchus, and lung cancers, twice the number of deaths from the next 2 common sites for mortality (liver and stomach)," reported the researchers of the Global Burden of Disease Study 2010 in an article in The Lancet. Lung cancer increased from the eighth to the fifth most common cause of overall mortality in the past 2 decades and still claims more lives than AIDS/HIV, the megaproject found.
- Oncothyreon of Seattle, WA, announced that the START phase III clinical trial of its L-BLP25 cancer immunotherapeutic agent did not meet its primary endpoint of improved overall survival in patients with unresectable, locally advanced stage IIIA or stage IIIB non–small cell lung cancer (NSCLC). L-BLP25 is designed to stimulate the immune system to target cells expressing the cell surface glycoprotein MUC1. More than 1,500 patients from 33 countries participated in the START trial. Notable treatment effects were seen for L-BLP25 in certain subgroups, according to Oncothyreon, which will continue with the separate INSPIRE phase III trial among patients of Asian heritage, which has a trial design that is almost identical to that of START.
- Postmenopausal survivors of breast cancer are at greater risk of developing diabetes than are age-matched women without breast cancer, according to a study published in Diabetologia. Among 24,976 breast cancer survivors and 124,880 control subjects, 9.7% developed diabetes over a mean follow-up period of 5.8 years, the study reported. Risk of diabetes for breast cancer survivors compared with women without breast cancer began to climb 2 years after diagnosis, with a 7% increased risk that rose to 21% after 10 years. However, among the subset of patients who received adjuvant chemotherapy, the risk was highest in the first 2 years after diagnosis (a 24% increased risk compared with controls) and then dropped to an 8% increased risk after 10 years.
- "More than 85% of the global burden of cervical cancer occurs in developing countries, where it accounts for 13% of all female cancers," Doyin Oluwole, MD, FRCP, executive director of the Pink Ribbon Red Ribbon initiative at the George W. Bush Foundation in Dallas, TX, noted in a blog entry. "Despite these staggering statistics, fewer than 5% of women are screened even once in their lifetime."
December 13, 2012
- Women with estrogen receptor–positive breast cancer who took tamoxifen for 10 years rather than the standard 5 years showed reduced recurrence and improved survival, with the greatest benefit seen in the second decade after diagnosis. Those were among the findings from the ATLAS (Adjuvant Tamoxifen—Longer Against Shorter) study presented at the Cancer Therapy and Research Center (CTRC) and American Association for Cancer Research (AACR) 2012 San Antonio Breast Cancer Symposium (SABCS) on December 5. Risk for death from breast cancer 5 to 14 years after diagnosis was 12.2% among those who continued use of tamoxifen versus 15% among those who stopped, according to results also published in The Lancet.
- Adjuvant chemotherapy produced higher rates of disease-free and overall survival for women with isolated local or regional recurrence of breast cancer, according to data presented at SABCS on December 5. "This is the first randomized controlled study that shows that adjuvant chemotherapy works in these patients," said Stefan Aebi, MD, a researcher from the Luzerner Kantonsspital in Luzern, Switzerland. The overall 5-year survival rate was 88% for women who received chemotherapy and 76% for those who did not. Patients with estrogen receptor–negative disease showed the largest benefit, with overall 5-year survival rates of 79% among those who received chemotherapy compared with 69% for those who did not.
- The University of Kentucky in Lexington began operating the first working model in the United States for electronic health record reporting of cancer cases to a state's cancer registry.
- The U.S. Food and Drug Administration (FDA) approved the use of Zytiga (abiraterone acetate; Janssen Biotech) to treat men with metastatic castration-resistant prostate cancer prior to chemotherapy. This move follows the April 20111 approval of Zytiga, which reduces testosterone production, for patients whose prostate cancer progressed after treatment with docetaxel. "Today's approval demonstrates the benefit of further evaluating a drug in an earlier disease setting," remarked Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.
- The University of Texas MD Anderson Cancer Center in Houston and GlaxoSmithKline (GSK) signed an agreement to develop and commercialize antibodies that activate the OX40 signaling molecule on T cells and promote an immune system attack against cancer. MD Anderson's Institute for Applied Cancer Science will collaborate with GSK under the agreement, said to have a potential value of more than $335 million.
- In many studies presented at SABCS, patients on the control arms "are doing better than expected in clinical trials pretty much across the board," noted C. Kent Osborne, MD, director of the Dan L. Duncan Cancer Center at Baylor College of Medicine in Houston.
- Peter Yu, MD, has been elected President of the American Society of Clinical Oncology for a one-year term beginning in June 2014. Yu is director of cancer research at Palo Alto Medical Foundation in Palo Alto, CA.
- "The lifetime of getting a drug into trial is often longer than that of a financially viable pharmaceutical company," commented Douglas Yee, MD, director of the Masonic Cancer Center at the University of Minnesota in Minneapolis, speaking at SABCS.
December 6, 2012
- The U.S. Supreme Court announced that it will hear arguments in a lawsuit against Myriad Genetics challenging the Salt Lake City, UT, company's right to patent BRCA1 and BRCA2. The suit claims that the genes are "products of nature" and that the patents restrict medical research and patients' access to medical care. In August, the U.S. Court of Appeals for the Federal Circuit ruled for the second time that isolated genes are patentable.
- The combination of docetaxel chemotherapy and the targeted drug selumetinib (AstraZeneca) was more effective than chemotherapy alone in a phase II clinical trial of 87 patients with KRAS-mutant non–small cell lung cancer (NSCLC), according to a study in Lancet Oncology, suggesting that the drugs work synergistically. Patients who received selumetinib lived a median of 5.3 months before their cancer worsened, compared with 2.1 months for those receiving chemotherapy alone. This is the first targeted agent, alone or in combination, to prove beneficial in patients with this type of NSCLC.
- Researchers at the Broad Institute of MIT and Harvard (Cambridge, MA) will collaborate with colleagues at Roche (Basel, Switzerland) to identify new uses for more than 300 of the company's compounds. The agents failed to make it to market for their original indication but may benefit patients with other diseases, including cancers. Financial terms of the agreement were not disclosed.
- Richard Nakamura, PhD, has been named the new director of the NIH's Center for Scientific Review (CSR). The CSR organizes the peer review groups that evaluate the majority of the 80,000 grant applications submitted to NIH every year.
- Harold Varmus, MD, director of the National Cancer Institute (NCI), said that NCI will expand its "zone of likelihood" for applications for grant funding to those scoring in the seventh percentile and better to the ninth percentile and better for fiscal year 2013. Grants scoring below the ninth percentile can be funded after an additional review. NCI aims to support about 1,100 new grants in FY 2013, which is in line with previous years.
- The American College of Physicians recommends limiting esophageal cancer screening to people with chronic heartburn who also have more serious symptoms such as bleeding, weight loss, anemia, and recurrent vomiting. Inappropriate use of upper endoscopy, the procedure used in screening, "generates unnecessary costs and exposes patients to harms without improving outcomes," according to clinical guidelines published in the Annals of Internal Medicine.
November 29, 2012
- Bayer's regorafenib improved median progression-free survival from 0.9 to 4.8 months in a phase III clinical trial of patients with metastatic gastrointestinal stromal tumor for whom imatinib (Gleevec; Genentech) and sunitinib (Sutent; Pfizer) were no longer effective, according to results of the 199-patient study published in The Lancet. A companion article in the journal reported that this multikinase-inhibitor oral drug, approved by the U.S. Food and Drug Administration in September to treat metastatic colon cancer after failure of standard chemotherapy, showed a modest benefit in median overall survival of 1.4 months in a phase III trial among 753 patients with that condition.
- The guidelines for screening mammography issued by the U.S. Preventive Services Task Force (USPSTF) in 2009 may lead to missed cancers, according to a study presented at the annual meeting of the Radiological Society of North America (RSNA) in Chicago on November 27. In 43,3521 screening exams performed at New York Presbyterian Hospital, 19% of detected cancers occurred in women in their 40s, who would not have been screened under the USPSTF guidelines.
- The U.S. National Cancer Institute has enhanced its AccrualNet website, with additional resources to help clinical trial professionals increase patient recruitment and create "communities of practice" to connect with their peers around the world.
- Using positron emission tomography and computed tomographic imaging (PET/CT), researchers documented physiologic evidence of "chemo brain," a common complaint in patients undergoing chemotherapy, according to research findings presented at the RSNA annual meeting on November 27. Researchers at West Virginia University School of Medicine and West Virginia University Hospitals in Morgantown analyzed PET/CT brain imaging results from 128 patients, which revealed statistically significant decreases in regional brain metabolism that were closely associated with chemo brain symptoms.
- India plans to build a National Cancer Institute facility that will be the nation's largest cancer center, at an All India Institute of Medical Sciences campus outside New Delhi.
- "Regardless of what happens in Congress, biomedical research must look to the private sector and not the federal government as the source of new funds," write Hamilton Moses III, MD, and E. Ray Dorsey, MD, MBA, of the Johns Hopkins University School of Medicine in Baltimore, MD, in a commentary to be published in the December 12 issue of JAMA. The authors propose new financial instruments, such as mutual funds for individual and institutional investors, biomedical research bonds, and patent pools to help cover the costs of discovery in biomedicine. "These measures are analogous to those used to build sports arenas, ports, bridges, or highways," they note.
November 21, 2012
- Roche's Avastin (bevacizumab) improved progression-free survival by 56% in people with newly diagnosed glioblastoma who were treated with radiation and chemotherapy, but improvements in overall survival did not reach statistical significance in an interim analysis of the phase III AVAglio trial. Final survival data are expected next year.
- Beginning as early as spring 2013, the NIH "will begin to hold processing of non-competing continuation awards if publications arising from grant awards are not in compliance with the public access policy," wrote Salley Rockey, PhD, deputy director for extramural research, in an entry on her blog. "We are giving funded organizations at least five months to prepare for our new process, and we hope you use this time to assure that publications are in compliance with the policy long before this change in process begins."
- Tata Memorial Hospital in Mumbai, India, and King's College London's Health Partners Integrated Cancer Centre in London, England, signed an agreement for joint cancer research and training.
- Janssen Research & Development, Merck, and Eli Lilly are establishing a global cross-pharmaceutical database designed to improve efficiencies of industry-sponsored clinical trials. The collaboration's Investigator Databank will act as a one-stop repository for key information about trial sites. It will serve as a foundation for a project being launched by the TransCelerate BioPharma initiative, whose other pharmaceutical industry members also are encouraged to join in.
- Among 28,582 U.S. patients who underwent craniotomy for a brain tumor, uninsured patients were twice as likely to die in the hospital as patients with private insurance. "We don"t have a medical explanation for why that is," noted Alfredo Quinones-Hinojosa, MD, of Johns Hopkins University School of Medicine in Baltimore, MD, lead author of a study published in the Archives of Surgery.
November 15, 2012
- Sanofi cut the price of Zaltrap (ziv-aflibercept) in half after criticism of the drug's cost-effectiveness in the New York Times by 3 Memorial Sloan-Kettering Cancer Center physicians. The company said that its action brings the price of the antiangiogenesis agent, approved in August by the U.S. Food and Drug Administration (FDA) for treatment of metastatic colon cancer, much nearer to that of the standard dose of its competitor, Avastin (bevacizumab; Genentech). The move "represents a success in moving toward value-based systems of care," commented Debra Patt, MD, MPH, in Community Oncology.
- Celgene said that its Abraxane produced a statistically significant improvement in overall survival in patients with metastatic pancreatic cancer. Results from the phase III study of 861 patients, who were also given gemcitabine and had not received previous treatment, will be presented at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium in January. A form of paclitaxel, Abraxane has been approved by the FDA for treatment of metastatic breast cancer and non–small cell lung cancer.
- Older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who were given the antibody–drug conjugate gemtuzumab ozogamicin (GO) were less likely to die than those given standard treatment, according to a report in the Journal of Clinical Oncology. Among 1,115 patients with a median age of 67 years, 25% of those given GO were alive after 3 years, compared with 20% of those who received standard treatment. Sold by Pfizer as Mylotarg, the drug was withdrawn from the market in 2010 due to safety concerns.
- Two articles in Nature Genetics separately reported exome sequencing and other genome analyses of Burkitt lymphoma (Love et al. and Richter et al.). Both groups of researchers identified recurrent somatic mutations in several genes, including ID3. Additionally, exome sequencing for 94 diffuse large B-cell lymphomas, which share many characteristics with Burkitt lymphoma, highlighted major differences in gene mutation patterns between the two types of cancer.
November 8, 2012
- The U.S. Food and Drug Administration granted priority review for marketing approval of trastuzumab emtansine (T-DM1; Genentech) in the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab (Herceptin; Genentech) and a taxane chemotherapy. The goal date for a decision on the antibody–drug conjugate is February 26, 2013. Additionally, the European Medicines Agency is reviewing a marketing authorization application from Genentech's parent company, Roche, for T-DM1 in treatment of HER2-positive metastatic breast cancer.
- Blind mole rats fight off cancer by a mechanism in which abnormally growing cells secrete the IFN-β protein, which rapidly kills off those cells, according to an article in the Proceedings of the National Academy of Sciences published by a team led by Vera Gorbunova, PhD, and Andrei Seluanov, PhD, of the University of Rochester in New York. In 2009 the researchers reported that the naked mole rat, the only other mammal not known to develop cancer, uses a different anticancer mechanism—early cell-contact inhibition induced by p16.
- The American Society of Clinical Oncology appointed Richard Schilsky, MD, to the new position of chief medical officer. Schilsky currently is chief of hematology/oncology in the Department of Medicine and deputy director of the University of Chicago Comprehensive Cancer Center.
- The prostate cancer drug market will climb from $4.1 billion in 2011 to $9.1 billion in 2021 in France, Germany, Italy, Japan, Spain, the United States, and the United Kingdom, according to estimates from Decision Resources of Burlington, MA. The firm expects the androgen receptor inhibitor Xtandi (enzalutamide; Medivation/Astellas) to become the top-selling prostate cancer agent in 2016.
- During later-stage clinical trials, 1 out of every 5 procedures collects extraneous data, at an average cost of more than $1 million per trial, the Tufts Center for the Study of Drug Development in Boston reported. The Tufts researchers noted that "the typical clinical trial protocol has an average of 13 endpoints, with the number of less essential endpoints per protocol nearly doubling the average level observed 10 years ago."
- After Hurricane Sandy flooded labs at New York University (NYU), researchers near and far offered their assistance. "We were able to save many things; it was just phenomenal to get that kind of help," NYU biochemistry and molecular pharmacology professor Danny Reinberg, PhD, told The New York Times. "Later in the week, at a Starbucks, I could finally download all my e-mail, and there were messages from people at the University of Pennsylvania and the Howard Hughes Medical Institute asking how they could help us re-establish the mouse lines we lost."
November 1, 2012
- The National Cancer Institute (NCI) gave the University of Michigan Comprehensive Cancer Center a $28.4-million 5-year grant and renewed its designation as a Comprehensive Cancer Center. The University said that it has received the most NCI funding among U.S. academic medical centers, with the Cancer Center receiving a total of $79 million in 2011. After submitting a 1,937-page grant renewal to the NCI, the Cancer Center underwent a 2-day site visit by reviewers in fall 2011.
- The U.S. Food and Drug Administration approved Synribo (omacetaxine mepesuccinate; Teva Pharmaceuticals) to treat adults with chronic myelogenous leukemia who have been treated with at least 2 tyrosine kinase inhibitors.
- Among U.K. women, two thirds of deaths of smokers in their 50s, 60s, and 70s are caused by smoking, according to a study of 1.2 million women reported in The Lancet. "Whether they are men or women, smokers who stop before reaching middle age will on average gain about an extra 10 years of life," commented coauthor Richard Peto, FRS, professor of medical statistics and epidemiology at the University of Oxford.
- Whole-genome sequencing was performed by the 1000 Genomes Project on 1,092 healthy individuals drawn from 14 populations worldwide, according to an articlein Nature.
- Cancer Research UK has launched ClicktoCure, a website that lets nonscientists aid in advancing research, initially in a Cell Slider project that categorizes images of cells. "It takes human intuition and the human eye to spot patterns, defects, and anomalies—computer algorithms just aren't good enough," a project note explains. "The process is slow for a lone scientist, but with the collective power of hundreds of thousands of people, we can speed up this research by years." In the first week, online volunteers analyzed more than 100,000 images.
- Many physicians may initially be hesitant to prescribe them, but by 2021 the market for biosimilar monoclonal antibodies for cancer will exceed $4.9 billion in the United States, the European Union, and Japan, predicts BioTrends Research Group of Exton, PA. Sales of branded versions will climb to $6.7 billion by that date, the company predicts.
October 2012, 2012
- Detailed analysis of 99 tumors from patients with early pancreatic ductal adenocarcinoma defined 16 significantly mutated genes, including novel mutated genes involved in chromatin modification and DNA damage repair. The research, reported in Nature, also identified diverse somatic aberrations in axon guidance pathway genes.
- Pfizer said a phase III study of Inlyta (axitinib) did not meet its primary endpoint of statistically significantly longer progression-free survival versus sorafenib (Nexavar; Bayer/Onyx Pharmaceuticals) in treatment-naïve patients with advanced renal cell carcinoma (RCC). An oral inhibitor of VEGF receptors 1, 2, and 3, Inlyta was approved this year for patients with previously treated advanced RCC in Australia, Canada, the European Union, Japan, Korea, Switzerland, and the United States.
- University of Pennsylvania scientists received a $4.9-million grant from the National Cancer Institute's Provocative Questions initiative to study how the brain's cognitive control system can be enhanced to improve decision-making processes and minimize risky behaviors such as smoking. The program will launch a randomized clinical trial with neuroimaging involving 150 young adults taking part in various programs for cognitive stimulation.
- The University of Tennessee Medical Center in Knoxville opened its new Cancer Institute, a $23-million facility that will bring treatment and research under one roof.
- Seattle Genetics of Bothell, WA, and Abbott Laboratories in Abbott Park, IL, expanded their antibody-drug conjugate (ADC) collaboration, which originally covered a single oncology target. Abbott now will pay $25 million upfront to use Seattle Genetics' auristatin-based ADC technology with antibodies to additional oncology targets, along with up to $220 million in potential milestone payments for each additional target, plus royalties on worldwide net sales of resulting products.
- A study of 1,274 patients across the United States revealed that 69% of patients with advanced lung cancer and 81% of patients with advanced colorectal cancer did not understand that the chemotherapy they were receiving was unlikely to cure their disease, according to a report in the New England Journal of Medicine.
October 18, 2012
- Across the globe, 169.3 million years of healthy life were lost due to cancer in 2008, according to a study in The Lancet that used a measure known as disability-adjusted life-years (DALY) and analyzed data from cancer registries worldwide. Colorectal, lung, breast, and prostate cancers were the main drivers of DALYs in most world regions and accounted for 18% to 50% of the total cancer burden in various regions. The researchers estimated an additional burden of 25% from infection-related cancers (liver, stomach, and cervical) in sub-Saharan Africa and 27% in eastern Asia.
- Daily use of a common multivitamin reduced the risk for total cancer occurrence by 8% in a population of men followed for more than a decade, in an analysis of Physicians' Health Study II results presented at the American Association for Cancer Research International Conference on Frontiers in Cancer Prevention Research on October 17 in Anaheim, CA. "This study suggests, at least for men, that there might be benefits to taking multivitamins in terms of cancer," said John Michael Gaziano, MD, chief of the Division of Aging at Brigham and Women's Hospital in Boston.
- The National Institutes of Health expects to invest more than $90 million over 5 years in a program to accelerate the development and application of single-cell analysis in various fields.
- The Carnegie Institution for Science in Washington, DC, and the University of Massachusetts Medical School in Amherst, MA, have received another U.S. patent covering application of RNA interference (RNAi) techniques. Patent 8,283,329, "Genetic inhibition of double-stranded RNA," is broadly directed to the use of RNAi to inhibit expression of a target gene in animal cells, the institutions said.
- "At Memorial Sloan-Kettering Cancer Center, we recently made a decision that should have been a no-brainer: we are not going to give a phenomenally expensive new cancer drug to our patients," wrote Peter Bach, MD, MAPP, Leonard Saltz , MD, and Robert Wittes, MD, in a commentary in the New York Times. "The reasons are simple: The drug, Zaltrap [Sanofi/Regeneron], has proved to be no better than a similar medicine we already have for advanced colorectal cancer, while its price — at $11,063 on average for a month of treatment — is more than twice as high … But because our medical culture equates 'new' with 'better' so unequivocally, a decision like this one can seem out of place at a leading cancer hospital."
October 11, 2012
- The first whole-genome sequencing of tumors and normal cells in 3 patients with pancreatic adenocarcinoma was reported in PLoS One. In all 3 case studies, the report identified multiple potential therapeutic targets.
- The UK Research Partnership Investment Fund is awarding 2 major grants for cancer research to the University of Oxford and various academic, industry, hospital, and philanthropic partners. One project will establish a £138-million center to develop, test, and implement personalized treatments, diagnosis, imaging, and therapy for patients with early-stage cancer. The other, a new program for drug target discovery, will be funded at £32 million.
- Driven by increased use of Celgene's Revlimid (lenalidomide) and the further adoption of combination therapies, the multiple myeloma drug market will grow from $4.4 billion in 2011 to $7.2 billion in 2021 in the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan, according to a forecast from Decision Resources of Burlington, MA.
- Beginning in 2014, Merck will close its campus in Whitehouse Station, NJ, and move its global headquarters to Summit, NJ. About 2,000 employees and contractors now housed in Whitehouse Station will move to new facilities in Summit or other nearby locations.
- Biotechnology tools company Life Technologies of Carlsbad, CA, is buying cancer bioinformatics firm Compendia Bioscience of Ann Arbor, MI. Compendia's Oncomine cloud-based analytics tool integrates high-throughput cancer profiling data across a large volume of cancer types to aid in finding correlations among genetic signatures, clinical status, and drug response markers. Life Technologies will develop a clinical version of Oncomine designed to let physicians compare their patients' genetic signatures against large data sets to determine the most effective drug protocols.
- More than 200 organizations sent a joint letter expressing concerns about NIH funding to the chair of the House Appropriations Committee's Subcommittee on Labor, Health and Human Services (HHS), Education, and Related Agencies. The current House bill "provides insufficient funds for NIH, imposes burdensome and duplicative certification requirements on NIH and HHS, and undermines the efforts of NIH to manage its portfolio effectively," declared the October 1 letter. "Crippling NIH by freezing its funding while at the same time reducing its flexibility with well-intended but ill-conceived mandates will ultimately delay the search for cures and treatments intended to benefit the American people."
October 4, 2012
- Findings from a study that claims to be the first large-scale trial of whole-genome cancer testing were reported at the European Society for Medical Oncology (ESMO) 2012 Congress this week in Vienna. In the SAFIR01 trial, researchers at the Institute Gustave Roussy in Villejuif, France, developed a program in which the entire genome from a biopsy of a metastatic lesion was analyzed prospectively for individual patients with metastatic breast cancer. Among biopsies of 402 patients, whole-genome analysis was performed in 248, and genomic alterations targetable by cancer drugs were found in 172 of the tumors.
- In the EMILIA phase III clinical trial of patients with metastatic HER2-positive breast cancer who have previously received trastuzumab (Herceptin; Genentech) and a taxane, risk of death was reduced by 32% among those treated with ImmunoGen's trastuzumab emtansine (T-DM1), compared with the standard-of-care treatment, lapatinib (Tykerb; GlaxoSmithKline) plus capecitabine (Xeloda; Genentech). Patients treated with the antibody-drug conjugate T-DM1 had a median survival of 30.9 months versus 25.1 months for those receiving the standard-of-care treatment, researchers reported in the New England Journal of Medicine.
- Based on the use of Rho kinase inhibitor and fibroblast feeder cells, a cell culture technique that conditionally reprograms both normal and tumor cells and permits them to proliferate indefinitely allowed researchers to identify an effective therapy for a patient with recurrent respiratory papillomatosis, according to an article in the New England Journal of Medicine.
- The U.S. Food and Drug Administration (FDA) approved the multikinase inhibitor Stivarga (regorafenib; Bayer) to treat patients with metastatic colorectal cancer. In August, the FDA approved the VEGF inhibitor Zaltrap (Sanofi-Aventis) for the same patient population.
- Cancer costs the European Union €117 billion annually, with health care accounting for 36% of the expense and lost earnings and unpaid care accounting for the rest, according to a study presented at the ESMO 2012 Congress. Most expensive are lung cancer (16% of total cost), colorectal cancer (11%), breast cancer (10%), and prostate cancer (5%), said researchers from the University of Oxford and King's College London.
- ArQule of Woburn, MA, and Daiichi Sankyo of Tokyo halted a phase III trial evaluating the MET inhibitor tivantinib (ARQ 197) in combination with erlotinib in previously treated patients with locally advanced or metastatic nonsquamous non–small cell lung cancer. An interim analysis concluded that the treatment would not boost overall survival.
- Patient-led advocacy efforts have shifted U.S. government priorities for medical research toward "perceived moral worthiness," commented Rachel Kahn Best, PhD, in American Sociological Review. "The downside is not every disease has this potential for strong advocacy. In addition to things like lung cancer and liver disease, which lose out because of the social stigma tied to those diagnoses, there are diseases like pancreatic cancer, whose patients often don't live very long after diagnosis and, therefore, don't have time to tell their stories."
September 27, 2012
- In a comprehensive study of samples from 825 patients published in Nature, The Cancer Genome Atlas (TCGA) has confirmed and greatly broadened the understanding of the 4 major subtypes of breast cancer: HER2-enriched, Luminal A, Luminal B, and Basal-like. "TCGA's comprehensive characterization of their high-quality samples allows researchers an unprecedented look at these breast cancer subgroups," said NIH Director Francis Collins, MD, PhD. Among results, the work uncovered marked genomic similarities between the Basal-like subtype (also called triple-negative although these tumors do not always test negative for estrogen, progesterone, and HER2 receptors) and high-grade serous ovarian cancer, and suggested that both cancers might be susceptible to anti-angiogenesis agents and compounds that target DNA repair.
- The University of Texas MD Anderson Cancer Center launched its Moon Shots Program, which will bring together sizable multidisciplinary groups of its researchers and clinicians to accelerate cancer research. The six initial Moon Shot teams will target acute myeloid leukemia/myelodysplastic syndrome, chronic lymphocytic leukemia, melanoma, lung cancer, prostate cancer, and triple-negative breast and ovarian cancers. Over the next decade, the program will be funded at up to $3 billion, which the center says will be separate from the approximately $700 million in its current annual research budget.
- Cancer patients "need to overcome a reluctance to provide personal clinical information and genetic information to a database that will help others," National Cancer Institute Director Harold Varmus, MD, remarked in a PBS interview. "I would urge patients who have cancer now to think of themselves as information donors who can benefit not just others who will have cancer later, but themselves over the next few years."
- The Food and Drug Administration has been given authority to ensure that clinical trial data are submitted properly to the Clinical Trial Registry and Results Data Bank, which presents information in the clinicaltrials.gov website.
- Cancer-related medical costs will more than double in some states in less than 8 years, reports a study by researchers from RTI International and the Centers for Disease Control and Prevention. The states with the highest projected expenses are California at $28.3 billion, Florida at $24.9 billion, Texas at $19.6 billion, and New York at $17.4 billion. The cost projections reflect expected demographic shifts and assume that the percentage of people treated for cancer would remain constant within age, sex, and state categories and that the inflation-adjusted cost of cancer care per person will increase by 3.6% per year.
- Peregrine Pharmaceuticals of Tustin, CA, uncovered major data problems in its recently reported Bavituximab phase II non–small cell lung cancer (NSCLC) trial. Earlier this month the company presented results indicating that adding the phosphatidylserine-targeting monoclonal antibody to docetaxel chemotherapy doubled overall response rate and improved progression-free survival and overall survival in late-stage nonsquamous NSCLC patients who had already received one chemotherapy regimen.
- Biotechnology firms with revenues exceeding $50 million did better than smaller firms last year, according to the consulting firm BDO USA of Chicago. On average, larger firms reported a 33% increase in revenue while smaller biotech companies saw a 12% decline from 2010. Overall, the bigger companies also boosted employment by 16% while smaller companies reduced their workforces by 3%.
- Astex Pharmaceuticals of Dublin, CA, discontinued clinical development of amuvatinib (MP-470), a multitargeted tyrosine kinase inhibitor that inhibits the mutant forms of c-Kit and platelet-derived growth factor receptor-α and disrupts DNA repair. Amuvatinib was being examined in a phase II study of platinum-refractory small cell lung cancer.
September 20, 2012
- BGI-Shenzhen of Shenzhen, China is acquiring Complete Genomics of Mountain View, CA, for approximately $117.6 million. Complete Genomics, which offers whole-genome sequencing services, will continue operating as a separate company. BGI is the world's largest sequencing organization.
- Unless the U.S. Congress agrees on trimming budget deficits dramatically by January, sequestration—automatic cuts triggered by the Budget Control Act of 2011—will diminish federal science budgets by 8.2%, according to a report from the White House Office of Management and Budget. "Not only will life-extending cancer research sustain a devastating hit, but providers of cancer care who are already struggling will be faced with significant cuts that will impede access to care," commented Sandra Swain, MD, president of the American Society of Clinical Oncology. "Sequestration will also hinder the federal review and oversight of new oncology treatments."
- Cancer has surpassed heart disease as the leading cause of death among Hispanics in the United States, according to a report from the American Cancer Society. Researchers expect that in time, this trend will encompass the country's entire population. This year, an estimated 112,800 new cases of cancer will be diagnosed and 33,200 cancer deaths will occur among Hispanics.
- Christopher Austin, MD, was named director of NIH's newest center, the National Center for Advancing Translational Sciences (NCATS), which aims to catalyze the generation of innovative methods and technologies to accelerate the development, testing, and implementation of diagnostics and therapeutics. Austin had been director of NCATS Division of Pre-Clinical Innovation since the NCATS launch in December 2011.
- Stand Up To Cancer and the St. Baldrick's Foundation teamed up to fund a Pediatric Cancer Dream Team, committing $14.5 million over the next 4 years to the effort. Based in Monrovia, CA, the St. Baldrick's Foundation has awarded more than $101 million in pediatric cancer research funding since 2005.
- The University of California San Diego Moores Cancer Center has started a "My Answer to Cancer" initiative for personalizing cancer treatment. The project will sequence the DNA of "large numbers" of patients to aid in providing each patient with optimal treatment.
- Bionomics Limited bought Eclipse Therapeutics of San Diego, which develops drug to target cancer stem cells, for $10 million.
September 13, 2012
- The Cancer Genome Atlas project released a comprehensive genomic characterization of 178 lung squamous cell carcinomas, published in Nature. The researchers demonstrated that the tumor type is characterized by highly complex genomic alterations, found statistically recurrent mutations in 11 genes, and discovered previously unreported loss-of-function mutations in the HLA-A class I major histocompatibility gene. Additionally, the work identified a potential therapeutic target in most tumors.
- Two studies published in Cell uncovered novel genes involved in non–small cell lung cancer (NSCLC) and highlighted major differences in mutations found in NSCLC patients with and without a history of smoking. One paper reported on massively parallel exome and genome sequencing of 183 tumor/normal DNA pairs for lung adenocarcinoma, the most common form of NSCLC. The other paper reported on whole-genome and transcriptome sequencing of tumor and adjacent normal tissue samples from 17 patients with NSCLC.
- Approval times for new oncology drugs in the United States average 10 months shorter than approval times for nononcology products, but take 2 months longer in the European Union, reports the Tufts Center for the Study of Drug Development. From 2002 through 2011, cancer therapies accounted for 19% of all new drug approvals in the United States and 12% in the European Union.
- Geron of Menlo Park, CA, is discontinuing a phase II study of imetelstat in metastatic HER2-negative breast cancer because median progression-free survival in the imetelstat arm was shorter than in the control arm. The company will continue to evaluate the telomerase inhibitor for 2 hematologic malignancies.
- The American Association for Cancer Research released its Cancer Progress Report 2012, which highlights the need for strong funding for cancer science. "Any further reduction in funding for cancer research and biomedical science would result in a major setback in our ability to develop even more effective interventions and save lives from cancer," said AACR President Frank McCormick, PhD, director of the UCSF Helen Diller Family Comprehensive Cancer Center.
- The Federation of American Societies for Experimental Biology, the Medical College of Wisconsin, the University of California San Francisco, and the American Association for the Advancement of Science have created myIDP, an online tool to help graduate students and postdocs prepare individual career development plans.
- The Stand Up To Cancer program received more than $81 million in pledges for cancer research from its September 7 fundraising telecast.
September 6, 2012
- Dozens of articles detailing results from the National Human Genome Research Institute's ENCODE (ENCyclopedia Of DNA Elements) DNA regulatory project were published together, with an overview in Nature. Hundreds of ENCODE consortium researchers across the United States, United Kingdom, Spain, Singapore, and Japan have carried out more than 1,600 sets of experiments on 147 types of tissue.
- The U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi; Medivation and Astellas Pharma) for patients with metastatic castration-resistant prostate cancer who previously received docetaxel.
- Johnson & Johnson subsidiary Janssen Biotech of Horsham, PA, has signed a global license and development agreement with Genmab of Copenhagen for daratumumab (HuMax-CD38). The CD38 monoclonal antibody is in phase I and phase II clinical studies for treating relapsed, refractory multiple myeloma.
- Additionally, the FDA gave a thumbs-up to the Abl and Src kinase inhibitor bosutinib (Bosulif; Pfizer) for patients with chronic, accelerated, or blast-phase Philadelphia-chromosome-positive chronic myelogenous leukemia who are resistant to or who cannot tolerate other therapies, including imatinib. The agency also gave a nod to a new pediatric formulation of everolimus (Afinitor; Novartis) for children ages 1 year and older with tuberous sclerosis complex who are diagnosed with subependymal giant-cell astrocytoma that cannot be treated with surgery.
- Quest Diagnostics released a diagnostic test for cervical cancer based on the telomerase RNA component (TERC) gene marker under a nonexclusive patent license from the NIH. TERC is amplified, indicated by an abnormal number of copies of the gene on chromosome arm 3q, in the precursor cells of cervical cancer, and the test may act as an adjunct to Pap and HPV screening, the Madison, NJ, company said.
August 30, 2012
- Researchers reported that the antibody–drug conjugate T-DM1 (trastuzumab emtansine) offers a significant increase in overall survival to patients with advanced or metastatic HER-2–positive breast cancer compared with a combination of lapatinib (Tykerb; GlaxoSmithKline) and capecitabine (Xeloda; Genentech). Roche, which is now seeking U.S. Food and Drug Administration approval for T-DM1, did not reveal the extent of the increase. Researchers had previously presented some data from the phase III EMILIA study, including an increase in progression-free survival, at the American Society of Clinical Oncology's annual meeting in June.
- A poll conducted by Research!America found that nearly two thirds of likely voters think that the next president should announce initiatives to encourage medical progress during his first 100 days in office. Other highlights: 68% believe the federal government should increase support for scientific research—and 53% would be willing to pay $1 more a week in taxes to pay for it.
- The Perelman School of Medicine at the University of Pennsylvania has been awarded a $12-million NIH grant to fund a new Center for Excellence in Prostate Cancer Disparities. The gap in prostate cancer mortality rates—62 per 100,000 in African American men compared with 26 per 100,000 men of European ancestry—is wider than that seen in any other major cancer.
- The U.S. Court of Appeals for the Federal Circuit upheld the validity of the patent on the Eli Lilly & Co. lung cancer drug Alimta (pemetrexed), affirming a lower court ruling. Teva Pharmaceutical Industries Ltd. had argued that the agent was covered by 2 earlier patents and should no longer be protected. The ruling blocks competition from generic formulations until 2017.
- In another court ruling, the U.S. Court of Appeals in Washington, DC, ruled that the federal government can't require tobacco companies to print graphic images on cigarette packaging showing how smoking can disfigure and kill people. The 2–1 decision affirmed a lower court ruling.
- New England Journal of Medicine article, researchers warned of a potential American "brain drain," writing, "If U.S. institutions are willing to devote money, training, and infrastructure to support talented, committed researchers, it would be an illogical waste of resources and poor long-term strategy to reduce federal grant mechanisms and wipe out potential job opportunities. Indeed, declining financial support may well encourage medical researchers to seek employment elsewhere."
August 23, 2012
- Treatment of U.S. cancer patients is now evenly split between independent community oncology practices and hospitals, as the number of community practices continues to drop, reports the market research firm Inside Oncology of Pipersville, PA.
- Despite years of global tobacco control efforts, 49% of adult men and 11% of women in developing countries use tobacco products, according to Global Adult Tobacco Survey results published in The Lancet. Quit rates are very low, with fewer than 20% of adults who had ever smoked in China, India, Egypt, Bangladesh, and Russia saying they had quit.
- The National Cancer Institute's Provocative Questions project began distributing grants, which will exceed $22 million among 57 recipients this year. Each grant addresses 1 of 24 questions about neglected or unsolved areas of oncology research.
- Mayo Clinic's Cancer Center will consolidate its Arizona operations in a single site on its Phoenix campus. A $130-million 3-floor facility, built above the first level of the clinic's proton beam therapy building now under construction, will be occupied in 2015. The expanded center is expected to add 820 jobs at Mayo Clinic over 10 years.
- Dainippon Sumitomo Pharma (DSP) of Osaka, Japan, is establishing a DSP Cancer Institute, headed by Chiang Li, MD, head of the DSP subsidiary Boston Biomedical Inc. (BBI). This year, BBI plans to create a global oncology research and development center in Cambridge, MA, with about 100 employees.
- Ruling on the BRCA1 and BRCA2 patent claims owned by Myriad Genetics of Salt Lake City, UT, the U.S. Court of Appeals for the Federal Circuit upheld the patents on the genes themselves and on a method of screening potential cancer therapeutics. However, the court rejected the company's patent claims for using DNA analyses to assess cancer risk. The case is expected to return to the Supreme Court.
- The small-molecule compound JQ1, originally synthesized at Dana-Farber Cancer Institute to inhibit the BRD4 gene, can generate reversible birth control in male mice, reported a paper in Cell. JQ1 also has proven effective in models of lung cancer, acute lymphoblastic leukemia, and multiple myeloma.
August 16, 2012
- In a phase II randomized clinical trial of 145 patients with late-stage or advanced differentiated thyroid cancer, treatment with vandetanib (Caprelsa; AstraZeneca) almost doubled progression-free survival, according to a paper in The Lancet Oncology. However, no significant improvement in overall survival was seen. The oral agent targets endothelial growth factor receptor (EGFR), vascular endothelial growth factor receptor (VEGFR), and RET (REarranged during Transfection) proteins.
- Using RNA sequencing and RNA interference screening, investigators at the National Cancer Institute have discovered essential regulatory pathways in Burkitt lymphoma that cooperate with MYC. "Our research suggests a number of targeted therapies that might be less toxic than the high-dose chemotherapy that is typically given to patients with Burkitt lymphoma in the U.S., even though they have cure rates approaching 90%," said Louis Staudt, MD, PhD, senior author on a report in Nature. "Such targeted therapies might also help children in Africa with Burkitt lymphoma, who only have cure rates of about 50% because intensive chemotherapy cannot be delivered safely in that setting."
- Adding Avastin to standard radiation therapy and chemotherapy for people with newly diagnosed glioblastoma provided a significant improvement in progression-free survival in a phase III trial. Results for overall survival—the other primary endpoint for the AVAglio trial—are expected next year.
- Amgen halted a phase III trial in which ganitumab, a monoclonal antibody that targets type 1 insulin-like growth factor receptor, was added to first-line treatment with gemcitabine (Gemzar; Eli Lilly) of patients with metastatic pancreatic adenocarcinoma. An interim analysis indicated that ganitumab treatment was unlikely to demonstrate a significant improvement in overall survival.
- People with type 2 diabetes who take thiazolidinedione drugs for 5 or more years are 2 to 3 times more likely to develop bladder cancer than those who take sulfonylurea drugs for the condition, according to a study of 60,000 U.K. patients published in the Journal of the National Cancer Institute.
- First-line treatment for patients with advanced renal cell carcinoma with Pfizer's Torisel (temsirolimus) combined with Avastin (bevacizumab; Genentech) failed to boost progression-free survival over treatment with Avastin plus IFN-α-2a in a phase III trial.
August 9, 2012
- The U.S. Food and Drug Administration approved the angiogenesis inhibitor Zaltrap (ziv-aflibercept; Sanofi) for use combined with a chemotherapy regimen to treat adults with metastatic colorectal cancer with tumors that are resistant to or progressing after an oxaliplatin-containing chemotherapy regimen. Zaltrap was evaluated in a randomized phase III clinical study of 1,226 patients with metastatic colorectal cancer; patients who received Zaltrap plus the FOLFIRI (folinic acid, fluorouracil, and irinotecan) combination showed a mean overall survival of 13.5 months compared with 12 months for those receiving FOLFIRI plus placebo.
- The NIH is expanding access to the NIH Clinical Center in Bethesda, MD, to extramural researchers. The nation's largest hospital devoted entirely to clinical research, the center until now exclusively served the NIH intramural research program. A new grant program, Opportunities for Collaborative Research at the NIH Clinical Center, will support partnerships with outside researchers.
- Patients in phase I trials of targeted cancer therapies showed a much lower risk of the most serious side effects than patients given traditional chemotherapy, according to two studies reported in Annals of Oncology. One analysis was reported by researchers at the Institute of Cancer Research and the Royal Marsden NHS Foundation and the other by investigators at the University of Texas MD Anderson Cancer Center.
- The University of Michigan Comprehensive Cancer Center in Ann Arbor is opening a translational oncology program that eventually will host up to 40 principal investigators, with teams focused on experimental therapeutics, cancer stem cells, molecular imaging, and genomics.
- A form of Herceptin (trastuzumab; Genentech) that can be delivered by subcutaneous injection appears to be as effective as intravenous formulations in treating women with HER2-positive breast cancer, demonstrating similar levels of pathologic complete response, in results from a phase III trial published in The Lancet Oncology.
- Leaders of the U.S. Congress expect to pass a continuing resolution next month to fund the federal government at current levels through March 30, avoiding a possible government shutdown before the fall election. The agreement does not affect the automatic budget cuts ("sequestration") scheduled to arrive in January if suitable measures are not taken to reduce the federal deficit. Sequestration would take a $2.4-billion bite out of the NIH budget, by common estimates.
August 2, 2012
- Researchers at Mayo Clinic in Rochester, MN, have completed the world's first genome-wide sequencing analysis of peripheral T-cell lymphomas, reporting their findings in Blood. Thirteen recurrent chromosomal rearrangements were identified, with 5 of them involving p53-related genes.
- The American Society of Hematology (ASH) will commit $9 million over a 3-year period to bridge grants for hematologists affected by severe restrictions on funding from the NIH. "Every year we brace for the possibility that the NIH budget will be cut, but this time it is different," said ASH president Armand Keating, MD, of Princess Margaret Hospital in Toronto. "The threat of reduced biomedical research funding over the long term is very real, and the devastating effects will be felt for the next decade or more."
- Women who last give birth at age 40 or older have a 44% decreased risk of endometrial cancer compared to women who have their last birth under the age of 25, according to a study in the American Journal of Epidemiology examining 8,671 cases of endometrial cancer and 16,562 control subjects.
- Fred Hutchinson Cancer Research Center is forming an Institute for Cancer Outcomes Research and Evaluation, which aims to improve the efficiency and effectiveness of cancer prevention, early detection, and treatment to reduce the economic and human burdens of cancer.
- Dendreon of Seattle, maker of the prostate cancer immunotherapy treatment Provenge (sipuleucel-T), has cut 600 jobs and will close 1 of its 3 manufacturing sites, as it seeks to reduce its annual costs by about $150 million. The company's net product revenue of $80 million in the quarter ended June 30 represented a drop of 2.4% from the previous quarter.
- From the first quarter to the second quarter of 2012, venture capital funding for life sciences dropped 9% to $1.4 billion, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and the National Venture Capital Association. "Given the regulatory challenges currently impacting the life sciences industry and the amount of capital required to fund these companies, it's no surprise that investments in this industry have declined for the fourth consecutive quarter," commented Tracy Lefteroff, global managing partner of the venture capital practice at PwC US.
- Widespread melanoma has been identified for the first time in a wild marine fish population, in coral trout on the Great Barrier Reef, according to a paper in PLoS ONE. Researchers noted that the trout habitat is directly beneath the world's largest hole in the ozone layer.
July 26, 2012
- The U.S. Food and Drug Administration (FDA) approved Afinitor (everolimus; Novartis) tablets for the treatment of postmenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. Approval of the mTOR inhibitor was based on results from the BOLERO-2 phase III trial among 724 postmenopausal women, in which treatment with Afinitor and exemestane extended median progression-free survival to 7.8 months, compared to 3.2 months with exemestane alone.
- Kyprolis (carfilzomib; Onyx Pharmaceuticals) gained FDA accelerated approval for treatment of patients with multiple myeloma who have received at least 2 prior therapies, including treatment with Velcade (bortezomib; Millennium Pharmaceuticals) and an immunomodulatory therapy. The intravenous agent was evaluated in a study of 266 patients published in Blood; overall response rate was 23% and median duration of response was 7.8 months.
- Bristol-Myers Squibb reported that the phase III BRISK-FL clinical trial of its investigational agent brivanib versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma did not meet its primary overall survival objective.
- The U.S. House Appropriations Subcommittee on Labor, Health and Human Services, and Education passed a fiscal year 2013 bill that would flat-fund the NIH at $30.6 billion. It would require the agency to maintain a 90:10 ratio of extramural to intramural funding, and allocate at least 55% towards basic science activities. Final legislation is not expected until after the fall election.
- The American Society of Clinical Oncology (ASCO) is creating a breast cancer–specific prototype for CancerLinQ, the society's initiative for a rapid learning system in cancer care. CancerLinQ is designed to assemble and analyze millions of unconnected medical records in a central knowledge base. In addition to supporting treatment decisions and measuring quality and performance, CancerLinQ will let investigators explore clinical data in unprecedented ways and generate research hypotheses, ASCO said.
- For the first time, the European Medicines Agency has recommended that the European Commission allow use of a gene therapy. Glybera, from UniQure of Amsterdam, treats lipoprotein lipase deficiency, a rare genetic disease. No gene therapies have been approved in the United States.
July 19, 2012
- Colon and rectal tumors had similar patterns of genomic alteration, according to The Cancer Genome Atlas (TCGA) findings reported in Nature. Examination of 224 colorectal cancer specimens highlighted mutations to genes found through prior research efforts (such as APC, TP53, SMAD4, PIK3CA, and KRAS) and identified other genes (including ARID1A, SOX9 and FAM123B) as potential drivers when mutated. The work also unveiled new mutations in the WNT signaling pathway, a finding that may encourage further development of WNT signaling inhibitors for treating this cancer.
- For $3 billion in cash, GlaxoSmithKline will buy Human Genome Sciences (HGS) of Rockville, MD. Among its cancer projects, HGS is running a randomized phase II trial of mapatumumab with sorafenib (Nexavar; Onyx Pharmaceuticals and Bayer HealthCare Pharmaceuticals) in advanced hepatocellular cancer. HGS also has been working with FivePrime Therapeutics of South San Francisco, CA, to develop and commercialize HGS1036, a first-in-class biologic that targets multiple members of the Fibroblast Growth Factor family.
- Hospira of Lake Forest, IL, recalled 4 of its injectable cancer drugs because of defects in their glass vials.
- GlaxoSmithKline withdrew its application for U.S. Food and Drug Administration approval for combining its lapitinib (Tykerb) with trastuzumab (Herceptin, Roche) for patients with HER2-positive metastatic breast cancer who had previously been treated with trastuzumab.
- Global spending on oncology drugs will reach at least $83 billion in 2016, making this the largest category among total drug spending, which will near $1.2 trillion that year, predicts a report from the IMS Institute for Healthcare Informatics of Parsippany, NJ.
- A study in the Annals of Oncology of 25,853 children diagnosed with cancer in Britain during 1978–2005 demonstrated an annual drop in the risk of death that ranged from 2.7% for rhabdomyosarcoma to 12% for germ cell tumors of the testes and ovaries. "The study shows how the increase in the proportion of children taking part in trials has gone hand in hand with improvements in survival," commented senior author Kathy Pritchard-Jones, MD, Professor of Paediatric Oncology at the Institute of Child Health at University College London. "It also emphasizes the importance of doctors working together to take the leadership role to make sure clinical trials and access to new treatments are available for children with cancer."
July 12, 2012
- The U.S. Food and Drug Administration (FDA) approved cetuximab (Erbitux; ImClone) for use in combination with FOLFIRI (combining irinotecan, 5-fluorouracil, and leucovorin) for first-line treatment of patients with K-Ras mutation-negative (wild-type), epidermal growth factor receptor–expressing metastatic colorectal cancer as determined by FDA-approved tests. The FDA also approved one such test from QIAGEN of Hilden, Germany.
- However, Merck Serono of Geneva, Switzerland, which licenses the drug for marketing outside the United States and Canada, said cetuximab did not meet the primary goal of progression-free survival among patients with advanced gastric cancer in the phase III EXPAND trial.
- Cells in early-stage lung cancer may undergo an epithelial–mesenchymal transition (EMT) that allows them to bypass cellular growth controls, according to a report in Science Translational Medicine. Investigators found that induction of the mouse Rac1b protein in lung epithelial cells of transgenic mice drove both EMT and tumor formation. Additionally, expression of Rac1b is elevated in human lung adenocarcinomas, and to higher levels in stage 2 tumors than stage 1 tumors. Drugs that inhibit Rac1b synthesis or function may be promising candidates to guard against metastasis, the researchers suggested.
- The FDA approved 40 oncology drugs between 2000 and 2011, compared to 30 drugs approved by the European Medicines Agency, says a study from the Tufts Center for the Study of Drug Development in Medford, MA. Among the 28 cancer drugs approved by both agencies, all were approved first by the FDA. Prices for medications averaged 9% cheaper in Europe.
- Adding bevacizumab (Avastin; Genentech) to chemotherapy provides no overall survival benefit or improvement in quality of life for women with advanced breast cancer, according to an analysis of 7 trials involving 4,032 patients published in the Cochrane Database of Systematic Reviews.
- This week the NIH Clinical Center welcomed 16 biomedical PhD students to a pilot course in clinical and translational research at the NIH campus in Bethesda, MA. Among lectures and interactive sessions in the 2-week program, students will participate in a mock institutional review board and learn how to file an investigational new drug application with the FDA.
July 5, 2012
- Researchers at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center have found that a human protein called AXL drives resistance to erlotinib (Tarceva; Genentech, Astellas). Erlotinib blocks an enzyme known as epidermal growth factor receptor (EGFR), but AXL "rescues" lung cancers from the EGFR inhibitor. The discovery, described in Nature Genetics, may lead to new drugs designed to block AXL.
- The U.S. Food and Drug Administration approved Beckman Coulter's Prostate Health Index blood test, which could reduce the need for some prostate biopsies. Indicated for men with a just-above-normal prostate-specific antigen (PSA) level of 4 ng/mL to 10 ng/mL, the test measures a PSA precursor protein called [-2] proPSA along with total and free PSA. In clinical trials, the assay was 2.5 times more specific in detecting prostate cancer than PSA alone, and it reduced the number of unnecessary biopsies by 31%.
- Carmen J. Allegra, MD, took over as editor-in-chief of the Journal of the National Cancer Institute. He succeeds Barnett S. Kramer, MD, MPH, who served in that role for the past 18 years.
- According to the annual survey of its members by the Association of American Medical Colleges, philanthropic support of medical schools and teaching hospitals increased by 19.4% on average, from $45.1 million in 2010 to $53.9 million in 2011. "The significant increase appears to signal a rebound in total private gift support from the recessionary years of 2009 and 2010," according to the executive summary of survey results. "The $53.9 million mean is slightly higher than the pre-recession mean of $51.4 million reported in 2008."
- Adaptive clinical trial design could boost enrollment in clinical trials, according to a Journal of the American Medical Association article. "It takes more preparation for the researchers up front, and more sophisticated statistical analysis as the trial is going on, but in the end, more study volunteers will be more likely to get the best option for them, and the results will still be scientifically sound," says the University of Michigan Health System's William Meurer, MD, the article's lead author.
June 28, 2012
- Roche is shutting down its Nutley, NJ, campus and consolidating oncology, virology, metabolism, and neuroscience research and development at existing sites in Germany and Switzerland. About 1,000 U.S. employees will be laid off. Roche said the move does not affect its Genentech subsidiary.
- By a margin of less than 1%, California voters turned thumbs down on a heightened cigarette tax, the proceeds of which would have gone to cancer research, diagnosis, and prevention efforts.
- The Texas Children's Cancer Center in Houston, TX, received a $10 million gift to open what is said to be the world's first pediatric lymphoma research center, known as the Fayez Sarofim Lymphoma Center.
- The U.S. Food and Drug Administration's (FDA) oncologic drugs advisory committee recommended approval for the investigational drug carfilzomib (proposed brand name Kyprolis; Onyx Pharmaceuticals) to treat patients with relapsed and refractory multiple myeloma who have received at least 2 prior lines of therapy. The FDA will make a decision next month.
- An article published in Cancer reports that physical activity, either mild or intense, may reduce breast cancer risk for women both before and after menopause. The study of 1,504 women with breast cancer and 1,555 women without the disease found that those who exercised 10 to 19 hours per week cut their risk by about 30%.
- The Wistar Institute and University of the Sciences, both in Philadelphia, launched a PhD program in cancer biology. Wistar is 1 of the 7 National Cancer Institute–designated Cancer Centers devoted solely to basic research.
- The automatic federal budget cuts that will go into effect in January if Congress does not pass sufficient deficit-reduction measures would affect every NIH program, director Francis Collins, PhD, told the House Energy and Commerce Subcommittee on Health. "We wouldn'’t do it in a completely blind fashion like a haircut, but everybody's hair would get cut—pretty significantly," said Collins. "There would be a lot of people with very short hair."
June 21, 2012
- Scientists reported in Nature on "surprising" alterations in breast cancer among genes not previously associated with the disease. One finding was recurrent fusions of the genes MAGI3 and AKT3 in triple-negative breast cancer. Another was recurrent rearrangements in the transcription factors CBFB and RUNX1, said to be discovered in solid tumors for the first time. The work included whole-exome sequencing of 103 tumors and DNA from normal tissue from patients in Mexico and Vietnam plus whole-genome sequencing of 22 tumors and matched normal tissue.
- Pfizer announced that Xalkori (crizotinib) significantly improved progression-free survival when compared with pemetrexed or docetaxel in previously treated patients with anaplastic lymphoma kinase-positive advanced non–small cell lung cancer. This was the primary endpoint in the phase III PROFILE 1007 study.
- The U.S. Senate Appropriations Committee approved a spending bill that would give a $100-million boost for the NIH and a $13-million increase for the National Cancer Institute (NCI) for fiscal year 2013. Final appropriations are not expected to be set until after the November federal election.
- Infinity Pharmaceuticals of Cambrige, MA, stopped phase II trials of its saridegib for treating chondrosarcoma and myelofibrosis. Results did not meet expectations for the oral molecule, which targets Smoothened, a key component of the Hedgehog pathway.
- The worldwide biotechnology industry achieved more than 10% revenue growth in 2011 for the first time since the start of the global financial crisis, according to Ernst & Young's annual biotech report. Research and development spending increased 9%.
- Georgia Tech in Atlanta launched an Integrated Cancer Research Center that brings together 48 biologists, bioengineers, chemists, and physicists from 7 schools and departments to take innovative approaches to cancer studies.
- The European Medicines Agency released final guidance on development of biosimilar copies of monoclonal antibody drugs.
- The population of cancer survivors in the United States, now estimated at 13.7 million, will near 18 million by 2022, according to a report by the American Cancer Society in collaboration with the NCI. The 3 most common cancers among male survivors are prostate cancer (43%), colorectal cancer (9%), and melanoma (7%). Among female survivors, the 3 most common cancers are breast (41%), uterine (8%), and colorectal (8%) cancer. In 2022, those proportions are expected to be largely unchanged.
June 14, 2012
- The U.S. Food and Drug Administration (FDA) approved Perjeta (pertuzumab; Genentech) to treat patients with HER2-positive late-stage (metastatic) breast cancer who have not received prior treatment with an anti-HER2 therapy or chemotherapy. Such therapy will combine Perjeta with Herceptin (trastuzumab; Genentech) and docetaxel.
- A total of 8 pharmaceutical firms now are participating in the Discovering New Therapeutic Uses for Existing Molecules program, launched by the NIH's National Center for Advancing Translational Sciences in May. The government–industry collaboration currently can match researchers with 58 compounds that have already been in clinical trials and might hold new therapeutic uses.
- Tokai Pharmaceuticals of Cambridge, MA, announced that the oral drug galeterone (TOK-001) has received Fast-Track designation from the FDA for treatment of metastatic castration-resistant prostate cancer (CRPC). Later this year Tokai will begin a phase II clinical trial of galeterone in patients with CRPC. Galeterone is said to aid in therapy for the disease by selectively inhibiting CYP17 lyase to prevent testosterone synthesis, antagonizing testosterone binding to the androgen receptor (AR), and degrading the AR protein.
- Dr. Reddy's Laboratories of Hyderabad, India, and Merck Serono of Geneva, Switzerland, will partner to develop, manufacture and sell biosimilar cancer therapies.
- Complete Genomics of Mountain View, CA, made layoffs and will shift its focus toward clinical applications for its whole-human genome sequencing service, while continuing to provide genomic data to its research customers.
- Six academic medical centers are joining in a consortium that will conduct clinical trials and research for patients with myelodysplastic syndrome (MDS). The MDS Clinical Research Consortium is a 5-year, $16 million privately funded initiative that includes Cleveland Clinic's Taussig Cancer Institute; Dana-Farber Cancer Institute in Boston; H. Lee Moffitt Cancer Center and Research Institute in Tampa; the Sidney Kimmel Comprehensive Cancer Center in Baltimore; The University of Texas MD Anderson Cancer Center in Houston; and Weill Medical College of Cornell University in New York.
- A specific population of cells in a specific location in the cervix can become cancerous when infected with human papillomaviruses, whereas other cells in the cervix apparently do not, according to a study in the Proceedings of the National Academy of Sciences.
- "Current approaches to assessing the value of innovative technologies and care delivery (e.g., comparative effectiveness research, cost-effectiveness analysis, and health technology assessments) are far from optimal in this new era of rapidly advancing personalized oncology," noted the authors of Sustaining Progress Against Cancer in an Era of Cost Containment, a discussion paper for the Turning the Tide Against Cancer Through Sustained Medical Innovation conference held June 12 in Washington, DC. Many experts "call for significant reforms, or entirely new models, for generating and assessing evidence of value in oncology," the authors added.
June 7, 2012
- A phase III trial among 199 patients demonstrated that Bayer's regorafenib improved outcomes for patients with gastrointestinal stromal tumors that progress due to resistance to other treatment options, including imatinib (Gleevec; Novartis) and sunitinib (Sutent; Pfizer). Progression-free survival was 4 times as long among patients receiving regorafenib than among those receiving placebo, researchers reported at the American Society for Clinical Oncology (ASCO) annual meeting in Chicago from June 1–5.
- In a phase II study reported at the ASCO meeting, patients with non–small cell lung cancer carrying KRAS mutations showed improved progression-free survival when treated with the MEK inhibitor selumetinib (Array BioPharma and AstraZeneca). This is the first prospective study to demonstrate a clinical benefit of a targeted therapy for patients with KRAS-mutant cancer of any type, investigators said.
- Updated data from the phase III AFFIRM trial presented at the ASCO meeting showed that men with castration-resistant prostate cancer previously treated with docetaxel maintained much better quality of life when they were treated with enzalutamide (formerly MDV3100; Medivation and Astellas Pharma), an androgen-receptor signaling inhibitor.
- Updated results presented at the ASCO conference from interim analyses of a phase II study among 1,088 men demonstrated that patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate (Zytiga; Janssen Research & Development) plus prednisone showed a statistically significant improvement in progression-free survival. Patients taking the androgen biosynthesis inhibitor showed a positive overall survival trend, but the trend had not reached a prespecified goal for statistical significance when the trial was stopped — a decision that has provoked controversy.
- In a survey among 5,499 U.S. cancer patients, 7.6% with an annual household income below $50,000 reported participating in cancer clinical trials, while 10.0% of those with higher incomes took part. Lower-income patients may be more concerned about copays and coinsurance, and more affected by indirect or hidden costs, than higher-income patients, noted Joseph Unger, MS, PhC, of the SWOG Statistical Center and the Fred Hutchinson Cancer Research Center in Seattle in a presentation at the ASCO conference.
- Global incidence of cancer will surge more than 75% above current levels by 2030, almost doubling in the poorest countries, predicts a study published in The Lancet Oncology.
- The U.S. House and Senate have passed relatively similar bills covering U.S. Food and Drug Administration (FDA) drug and device approvals, including the first provisions for makers of generic drugs and biosimilars to pay user fees that would help to fund FDA approval decisions on their products.
- Roche and Bristol-Myers Squibb are working with Cancer Research UK to conduct clinical trials that leverage the Stratified Medicine Programme, launched last year with a goal of genetically testing tumor samples from 9,000 patients in the United Kingdom across 6 tumor types.
May 31, 2012
- The St. Jude Children's Research Hospital–Washington University Pediatric Cancer Genome Project has released whole-genome sequences with matched sets of normal and tumor tissue samples from 260 pediatric cancer patients. Launched in 2010, the Pediatric Cancer Genome Project is said to be the first major privately funded human genome sequencing project to share its data as soon as it becomes available.
- Bayer HealthCare of Wayne, NJ, has submitted a New Drug Application to the U.S. Food and Drug Administration for the oral multi-kinase inhibitor regorafenib in treating patients with metastatic colorectal cancer. The submission builds on the phase III CORRECT (Colorectal Cancer Treated with Regorafenib or Placebo after Failure of Standard Therapy) trial, whose results will be updated at the American Society for Clinical Oncology annual meeting in June.
- More than half the members of the U.S. Senate and House of Representatives are supporting the Pancreatic Cancer Research and Education Act, designed to ensure that the National Cancer Institute (NCI) develops a long-term comprehensive strategic plan for developing early diagnostics and treatment options that increase survival for patients with pancreatic cancer. The disease is the fourth-leading cause of cancer death in the United States and receives about 2% of NCI spending, says the Pancreatic Cancer Action Network of Manhattan Beach, CA.
- People who repeatedly took nonsteroidal anti-inflammatory drugs, such as aspirin and ibuprofen, showed a 15% decreased risk for developing squamous cell carcinoma and a 13% decreased risk for developing malignant melanoma in a study of more than 180,000 residents of northern Denmark published in Cancer.
- Celldex Therapeutics of Needham, MA, announced that preliminary results for a phase IIb study with 122 patients show that in patients who have advanced and heavily pretreated breast cancer with high expression of glycoprotein NMB (GPNMB), treatment with its CDX-011 (glembatumumab vedotin) antibody-drug conjugate resulted in a 32% overall response rate (ORR) compared to 13% ORR with single-agent chemotherapy. Additionally, in patients with triple negative breast cancer who also highly express GPNMB, CDX-011 treatment demonstrated an ORR of 36%, according to Celldex, which expects to update trial results by year-end.
- Foundation Medicine of Cambridge, MA, has launched FoundationOne, a genomic profiling service that identifies a patient's individual molecular alterations and helps match them with relevant targeted therapies and clinical trials. The test can simultaneously detect multiple classes of genomic alterations in around 200 cancer-related genes, said the company, which added that its next-generation sequencing technology can obtain clinical-grade results from as little as 50 mg of DNA obtained from formalin-fixed paraffin-embedded tumor tissue samples.
- Scientists at Imperial College London (UK) and the University of Vigo (Spain) have created an ultra-sensitive testing approach for detecting biomarkers at very low concentrations. As reported in Nature Materials, biosensors designed to detect prostate-specific antigen (PSA) consist of nanoscale gold stars with two types of antibodies for latching onto PSA, and one of the antibodies can be detected via optical microscope. The test can spot PSA at levels 9 orders of magnitude below those found in the existing ELISA test, the researchers said.
May 24, 2012
- Medivation of San Francisco has submitted a new drug application to the U.S. Food and Drug Administration for enzalutamide (formerly MDV3100) for treating castration-resistant prostate cancer in patients previously treated with chemotherapy. Medivation requested priority review (which gives the goal of 6 months for completing the review) for the drug, an oral agent that inhibits androgen receptor signaling in 3 distinct ways. In November 2011, a planned interim analysis of the phase III AFFIRM trial showed that enzalutamide significantly improved survival compared to placebo.
- The ECOG-ACRIN Cancer Research Group officially began operations this month. Headquartered in Philadelphia, PA, the group is based on a merger of the Eastern Cooperative Oncology Group (ECOG) and the American College of Radiology Imaging Network (ACRIN) and includes almost 650 institutions. "ECOG-ACRIN establishes for the public and private sectors one organizational structure capable of studying the entire cancer care pathway–prevention and screening, surveillance, early detection, staging, diagnosis, treatment, follow-up, and survivorship," said co-chairs Robert Comis, MD, of Drexel University and Mitchell Schnall, MD, PhD, of the University of Pennsylvania.
- Agilent Technologies of Santa Clara, CA, will acquire Dako of Glostrup, Denmark, for $2.2 billion. Dako, whose annual revenue was about $340 million in 2010, provides products used in cancer diagnostics by pathology laboratories and collaborates with pharmaceutical firms in creating companion diagnostics for targeted therapies.
- Peregrine Pharmaceuticals of Tustin, CA said that a phase IIb trial of bavituximab plus docetaxel versus docetaxel in patients previously treated with chemotherapy for non–small cell lung cancer demonstrated a doubling of overall response rates and an improvement in progression-free survival. Bavituximab is a first-in-class monoclonal antibody targeting phosphatidylserine, an immunosuppressive molecule that becomes exposed on the outside of cells lining tumor blood vessels, the company said.
- There are 55 breast cancer therapeutic drugs under development in the United States and 24 such drugs will be approved by 2017, estimates a market report from Frost & Sullivan in Mountain View, CA.
- Family characteristics, high fetal growth, older maternal age, low birth order, and male gender are among the factors influencing early life non-Hodgkin lymphoma (NHL) incidence, according to a report in the Journal of the National Cancer Institute. The analysis is a national cohort study conducted among people born in Sweden between 1972 and 2008. NHL incidence has continued to climb in children, adolescents, and young adults.
- Among 255 patients who survived heart transplants for more than a year, use of statins reduced the risk of any cancer by 65%, University Hospital Zurich (Switzerland) researchers reported at the Heart Failure Congress 2012 this month in Belgrade, Serbia.
May 17, 2012
- Three studies reporting on whole-genome sequencing of breast cancer by Wellcome Trust Sanger Institute researchers and colleagues were published this week. A Nature paper analyzing 100 tumors identified driver mutations in 9 new genes, with a total of at least 40 mutated driver genes and 73 combinations of mutated driver genes. The maximum number of driver mutations in an individual cancer was 6. Additionally, 2 reports in Cell analyzed genomes of 21 breast cancers. One article extracted mutational signatures of underlying processes and spotlighted a phenomenon of localized hypermutation that the researchers dubbed "kataegis" after a Greek word for thunderstorm. The other paper analyzed mutational processes across a tumor's lifetime.
- The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Europe and Canada, according to a study in the New England Journal of Medicine. Between 2001 and 2010, median total time to review was 322 days at the FDA, 366 days at the European Medicines Agency (EMA), and 393 days at Health Canada.
- Biovest International of Tampa, FL will seek approval from the EMA for its BiovaxID personalized cancer vaccine for the treatment of follicular non-Hodgkin lymphoma. The company also plans to begin discussions with the FDA for approval of the vaccine.
- Cancer Genetics of Rutherford, NJ, which offers genomic tests for cancer diagnosis and treatment, sought to raise $48 million in its IPO this week.
- In patients with metastatic soft-tissue sarcoma, treatment with the antiangiogenic agent pazopanib (Votrient; GlaxoSmithKline) nearly tripled progression-free survival (PFS) compared with placebo, in results published in The Lancet. The PALETTE trial is said to be the first randomized phase III trial in metastatic soft-tissue sarcoma to demonstrate improvement in PFS, but patients showed no significant gain in overall survival.
- A study reported in Cancer found no link between the use of β blockers for treating high blood pressure and colorectal cancer risk, after interviewing 1,762 patients with colorectal cancer and 1,708 cancer-free individuals.
- OncoMed Pharmaceuticals of Redwood City, CA, which develops therapies against cancer stem cells, filed for a U.S. initial public offering (IPO) of stock that would raise up to $115 million.
- "It will be essential for the FDA to clearly communicate to all stakeholders what biosimilar products are and are not," Joseph Miletich, MD, PhD, senior vice president of research and development at Amgen in Thousand Oaks, CA, testified at an FDA hearing this month. "For example, there should be no perception, implied or otherwise, that an FDA-approved biosimilar is somehow less effective or less safe than the reference product."
May 10, 2012
- The NIH National Center for Advancing Translational Sciences (NCATS) launched a collaborative program that opens up certain pharmaceutical industry compounds to outside researchers. In a pilot phase, NCATS joined with AstraZeneca, Eli Lilly, and Pfizer, which initially will make available more than 20 compounds that have cleared several key steps in drug development, including safety testing in humans, but not progressed to approval for clinical use. "I don't think NIH has had this scale of collaboration with the private sector in the past," commented Kathy Hudson, PhD, NCATS acting deputy director.
- Whole-genome sequencing of 25 metastatic melanoma tumors has confirmed the role of chronic sun exposure and revealed the existence of many structural rearrangements in this tumor type, according to an article in Nature. Scientists detected known BRAF and NRAS mutations in 24 of the 25 tumors, while PREX2, previously implicated in breast cancer for blocking a tumor-suppressor pathway, was altered in 44% of those patients.
- Congressman Tom Reed (R-NY) introduced legislation in the U.S. House of Representatives aimed to strengthen public reporting of cancer trials conducted with federal grant money. The bill would mandate that recipients of unreported research repay the grant in full and be ineligible for future grants.
- Infectious agents cause around 2 million new cancer cases a year globally, of which 80% occur in less developed regions, according to estimates published in The Lancet Oncology. "Application of existing public-health methods for infection prevention, such as vaccination, safer injection practice, or antimicrobial treatments, could have a substantial effect on future burden of cancer worldwide," said lead authors Catherine de Martel, MD, and Martyn Plummer, PhD, from the International Agency for Research on Cancer in Lyon, France.
- The National Academy of Sciences elected 84 new members and 21 foreign associates in recognition of their achievements in original research.
- Genomic Health and OncoMed, both of Redwood City, CA, have partnered to identify biomarkers that will aid clinical development of the latter's antibody cancer therapeutics, which target biologic pathways critical to the survival of cancer stem cells.
- A $25 million gift to the University of Pennsylvania will establish The Basser Research Center, focused on the treatment and prevention of cancers associated with hereditary BRCA mutations.
May 3, 2012
- The U.S. Food and Drug Administration (FDA) approved the antiangiogenesis agent pazopanib (Votrient; GlaxoSmithKline) for the treatment of patients with advanced soft tissue sarcoma. "Soft tissue sarcomas are a diverse group of tumors, and the approval of pazopanib for this general class of tumors is the first in decades," noted Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
- The FDA rejected Amgen's application to expand the use of denosumab (Xgeva) to delay bone metastasis in patients with advanced prostate cancer.
- Celgene International (Summit, NJ) and Epizyme (Cambridge, MA) will partner to develop cancer therapies based on inhibiting histone methyltransferases (HMT), an epigenetic target class. Epizyme will receive $90 million upfront (which includes an equity investment) plus certain royalties on sales outside the United States as well as milestone payments that potentially could exceed $160 million for each HMT inhibitor that Celgene licenses.
- The Obama administration released a National Bioeconomy Blueprint, a 48-page report that summarizes recent federal initiatives and ongoing programs to accelerate progress in bioscience and bioengineering.
- Among 13 industrialized nations, the United States has the highest survival rates for breast cancer and is tied with Norway for best survival with colorectal cancer, according to a study from The Commonwealth Fund. However, cervical cancer survival rates in the United States are below average.
- Women have a 30% relative advantage over men in all aspects of the progression of localized melanoma, in an analysis of 2,672 patients reported in the Journal of Clinical Oncology.
- A U.K. National Institute for Health and Clinical Excellence (NICE) committee recommended nilotinib (Tasigna; Novartis) but not dasatanib (Sprycel; Bristol-Myers Squibb) for treating chronic myeloid leukemia (CML). "Although no trials directly comparing dasatinib and nilotinib were available, the committee concluded from indirect comparisons that dasatinib and nilotinib could be considered equally as effective in treating CML," commented Carole Longson, PhD, director of the NICE Centre for Health Technology Evaluation. "However, the manufacturer of nilotinib has already agreed with the Department of Health to provide the drug to the National Health Service at a discounted price. This reduction in cost enabled the independent Committee to approve nilotinib."
- The second-generation histone deacetylase (HDAC) drug CHR-3996 was shown to be safe and to demonstrate preliminary clinical activity in a phase I trial of 39 patients with a range of advanced cancers, according to an article in Clinical Cancer Research.
- "Investigators with a PhD have a slightly lower [NIH] funding rate than those with medical degrees, and this is consistent over time," remarked Sally Rockey, PhD, NIH's Deputy Director for Extramural Research, in her blog. "To keep these data in context, remember that about 30% of principal investigators hold MDs or MD/PhDs."
- Turning data from cancer research into discoveries will require fundamental changes in the way researchers share data, access patient samples, and gather informed consent, remarked John Quackenbush, PhD, at the Bio-IT World Conference and Expo 2012 in Boston. "The biggest barriers are not technical or intellectual; the biggest barriers are cultural," said Quackenbush, who leads the Center for Cancer Computational Biology at the Dana-Farber Cancer Institute.
April 26, 2012
- The NIH extramural budget will drop by 11.1% ($2.8 billion) in January 2013 if the Budget Control Act of 2011's "sequestration" mechanism kicks in, suggested an analysis from the Federation of American Societies for Experimental Biology (FASEB). "These estimates are conservative as they do not account for either the rising costs of research due to inflation or ongoing efforts to shift the burden of sequestration from defense to non-security programs or exempt certain programs from the mandated cuts," said Howard H. Garrison, PhD, FASEB deputy executive director for policy.
- Indiana University Health and the Indiana University School of Medicine, both of Indianapolis, will invest $150 million over 5 years in a research collaboration. One main goal is to enable the Indiana University Melvin and Bren Simon Cancer Center to become a National Cancer Institute (NCI) comprehensive cancer center.
- "The general impression is to expect a flat [NCI] budget for the next 5 years," said Stan Gerson, MD, director of the Case Comprehensive Cancer Center, following a meeting with NCI head Harold Varmus and directors of NCI-designated cancer centers. Noting "the expectation that 3 to 5 additional cancer centers will join as NCI-designated over the next 5 years," Gerson added that "the budgets of the additional centers will likely reduce available funds to existing centers."
- In a study of 118 patients with various types of brain cancers, microRNA profiling of cerebrospinal fluid could determine the presence of glioblastoma, researchers reported in Neuro-Oncology.
- The European Patent Office has awarded Rosetta Genomics of Philadelphia, PA, a patent covering the use of the microRNA miR-34a in drugs for treating p53-negative cancers. The company says that miR-34a is a direct transcriptional target of p53 and that perturbation of miR-34a expression may contribute to tumorigenesis.
- The American Cancer Society (ACS) released its latest Nutrition and Physical Activity Guidelines for Cancer Survivors report. "This is the first time the evidence has been strong enough to release formal guidelines for survivorship, as we've done for cancer prevention," said Colleen Doyle, MS, RD, ACS director of nutrition and physical activity. The report includes specific recommendations for people diagnosed with breast, colorectal, endometrial, ovarian, lung, prostate, head and neck, and hematologic cancers.
- Childhood obesity is positively linked with developing hepatocellular carcinoma in adulthood, according to a study of 165,540 men and 160,883 women by the Fatty Liver Inhibition of Progression consortia, presented at the International Liver Congress 2012 in Barcelona on April 19.
- New interim guidelines for lung cancer screening from the American Lung Association recommend low-dose CT scans for current or former smokers (ages 55 to 74 years) with a smoking history of at least an average of a pack a day for 30 years and no history of lung cancer.
April 20, 2012
- Adding bevacizumab (Avastin; Genentech) to the standard chemotherapy regimen for non–small cell lung cancer (NSCLC) did not lead to significantly increased survival rates for patients over the age of 65, according to a report in the Journal of the American Medical Association. The authors advised that for cancers such as NSCLC that tend to arise in elderly patients, clinical trials of new therapies should include an adequate number of older patients and analysis of data for those patients.
- Merck of Whitehouse Station, NJ, and Endocyte of West Lafayette, IN, will jointly develop and commercialize Endocyte's vintafolide (EC145), a drug conjugate that links folate with a chemotherapy agent. Vintafolide is being evaluated in a phase III clinical trial for platinum-resistant ovarian cancer and a phase II trial for NSCLC. Both studies are using Endocyte's companion diagnostic agent, etarfolatide (EC20). Endocyte will receive a $120 million upfront payment from Merck and is eligible for milestone payments up to $880 million.
- As Congress studies reauthorization of the Pediatric Research Equity Act, the Alliance for Childhood Cancer has asked that the revised bill require pediatric oncology studies when a relevant target or pathway is explicitly included in the product label for a new adult oncology drug and is highly relevant to any pediatric cancer.
- The Princess Margaret Hospital Foundation in Toronto kicked off a 5-year campaign to raise $1 billion Canadian ($1 billion U.S.), half from donors and half from research grants, to boost its personalized cancer medicine and research programs.
- In a phase II trial of autologous heat shock protein peptide vaccine (HSPPC-96) for recurrent glioblastoma multiforme, 43 patients achieved a median survival of 48 weeks, compared to 33 weeks for 86 control patients. HSPPC-96 is made from a patient's individual tumor containing glycoprotein-96 associated with cancer-specific antigenic peptides. The results suggest that survival could be extended further by combining the vaccine with other drugs that enhance the immune response it produces, and a trial combining the vaccine with bevacizumab will begin enrolling patients this year. Andrew Parsa, MD, PhD, of the University of California, San Francisco led the study, which was reported on April 17 at the American Association of Neurological Surgeons meeting in Miami.
- Members of the Pharmaceutical Research and Manufacturers of America said their investments in research and development totaled $49.5 billion in 2011. Their U.S. R&D expenses were estimated at 21% of domestic sales.
- Digital chest tomosynthesis may offer detection of lung cancer at rates similar to that of computed tomography but at lower costs and radiation doses, said surgeons from S. Croce e Carle Hospital in Cuneo, Italy. They studied the screening technique in more than 1,500 patients with no previous evidence of cancer and reported results at the 3rd European Lung Cancer Conference in Geneva, Switzerland, in April.
April 12, 2012
- Scientists have discovered why diabetic-like symptoms develop in some patients given rapamycin, a drug now being tested in many cancer clinical trials. A study published in Cell Metabolism shows that normal mice given rapamycin were more likely to have trouble regulating their blood sugar because of a drop in insulin signaling, triggered by activity of a protein called Yin Yang 1 (YY1). Animals in whose muscles YY1 was knocked out were protected against the development of diabetes-like symptoms.
- Stephen D. Nimer, MD, has been appointed director of the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine in Florida. An internationally recognized expert on leukemia and stem cell transplantation, Nimer was previously the vice chair for faculty development at Memorial Sloan-Kettering Cancer Center's Department of Medicine.
- People with Huntington's disease or other polyglutamine neurodegenerative disorders show significantly reduced risks of cancer, noted an article in The Lancet Oncology.
- A phase III trial of Bayer HealthCare's regorafenib (BAY 73-4506) for treatment of patients with metastatic gastrointestinal stromal tumors met its primary endpoint of better progression-free survival.
- Researchers led by the Duke–National University of Singapore Graduate Medical School in Singapore and the National Cancer Centre of Singapore say they have identified hundreds of novel genes that are mutated in stomach cancer. A paper about the exome study of 15 gastric adenocarcinomas and their matched normal DNAs appears in Nature Genetics.
- Work in mice reported in Nature Nanotechnology indicates that normalizing blood vessels within tumors via anti-angiogenesis agents, which may improve the delivery of standard chemotherapy drugs, can increase the penetration of the smallest nanotherapeutic agents but can block larger nanotherapeutic agents.
- Sanofi of Paris and Regeneron Pharmaceuticals of Tarrytown, NY, got good and bad news about the angiogenesis inhibitor aflibercept (Zaltrap). The U.S. Food and Drug Administration granted priority review for the agent in combination with chemotherapy for patients with metastatic colorectal cancer. But patients in a phase III trial combining Zaltrap with docetaxel and prednisone for the first-line treatment of metastatic androgen-independent prostate cancer did not show improvement in overall survival.
Reporting from the AACR Annual Meeting
- The U.S. Food and Drug Administration (FDA) hopes to soon issue final guidance for industry on the codevelopment of two or more unmarketed investigational drugs for combination use. "We're still wading through all of the comments" on the draft guidance document that was published in December 2010, said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, at a panel at the American Association for Cancer Research (AACR) Annual Meeting 2012 on April 3.
- Peptide vaccination in children with gliomas was tolerated well, with evidence of immunological and clinical responses, Ian F. Pollack, MD, of the University of Pittsburgh School of Medicine reported at the AACR Annual Meeting 2012 on April 2. Among 22 children vaccinated with peptides for glioma-associated antigen epitopes every 3 weeks for 8 courses, 4 had rapidly progressive disease, 14 had stable disease for more than 3 months, 3 had sustained partial responses, and 1 had prolonged disease-free status after surgery. "This was the first study of its type that examined peptide vaccine therapy for children with brain tumors like this," said Pollack. He added that seeing tumor shrinkage in children with very high-risk tumors "has been extremely encouraging and somewhat surprising."
- Today's rapid advances in understanding cancer "are now under unprecedented threat from reduced funding," said American Association for Cancer Research (AACR) president Judy Garber, MD, PhD, during the opening plenary session at the AACR Annual Meeting 2012 on April 1. "We already see the effects on our most precious resource, young investigators. This is potentially disastrous." The AACR will redouble its efforts to engage with Congress to make research funding a higher national priority, and call on its 34,000 members and its partners to jointly explain and illustrate the value of cancer research.
- Four aberrantly activated translational proteins regulated by the PI3K/mTOR molecular signaling pathway are associated with poor prognosis in hormone-receptor-positive breast cancer, researchers reported at the AACR Annual Meeting 2012 on April 1. Funda Meric-Bernstam, MD, of The University of Texas MD Anderson Cancer Center, and her colleagues analyzed tumors from 190 patients. The 4 aberrations that were predictors of overall survival included increased phosphorylation of ribosomal protein S6 and of translation initiation factor 4E-binding protein 1, increased expression of eukaryotic elongation factor 2 kinase, and decreased expression of programmed cell death protein 4.
- Patients with castration-resistant prostate cancer (CRPC) had limited side effects and in many cases a drop in prostate-specific antigen (PSA) expression with galeterone (TOK-001), an oral drug with 3 mechanisms of action. The phase I data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2012 by R. Bruce Montgomery, MD, of Washington School of Medicine in Seattle, WA. In a study of 49 patients with CRPC, 49% had PSA reductions of 30% or more. Researchers will investigate long-term safety and efficacy in a phase II study that Tokai Pharmaceuticals plans to launch later this year.
- "Data suggest that research participants and the public want and expect return of individual research results and incidental findings, yet research practice has been not to return them," said Susan Wolf, JD, of the University of Minnesota in Minneapolis during a discussion at the AACR Annual Meeting 2012 on April 2. "We as a scientific community are going to have to deal with this. The ostrich days of 'head in the sand' are over."
- "Whole-genome sequencing is enabling us to zero in on the specific challenges presented with each individual triple-negative breast cancer tumor, advancing a 'personalized medicine' approach," said John Carpten, PhD, of the Translational Genomics Research Institute in Phoenix, AZ, speaking at the AACR Annual Meeting 2012 on April 2. He added that whole-genome analyses "not only will inform us on therapies, they might inform us on combination therapies."
- Arul M. Chinnaiyan, MD, PhD, of the University of Michigan, and Charles L. Sawyers, MD, of Memorial Sloan-Kettering Cancer Center, will lead a Stand Up To Cancer (SU2C) Dream Team project for advanced prostate cancer. At the American Association for Cancer Research (AACR) Annual Meeting 2012 on April 1, SU2C and the Prostate Cancer Foundation announced a $10-million grant for the 3-year project among 7 centers.
- In today's cancer research, "most biomarker hypotheses are wrong," Mark Ratain, MD, of the University of Chicago School of Medicine told a session at the AACR Annual Meeting 2012 on April 2. "The field is filled with false discovery. Good drugs can potentially be misdeveloped with flawed biomarkers, and you can pick exactly the wrong [patient] population if you don't understand what's going on."
- Adaptive clinical trial design "should be adaptive by design, not an ad hoc change of trial conduct," commented Keaven Anderson, PhD, from Merck Research Laboratories in North Wales, PA, during a session on highly adaptive trials in drug development at the AACR Annual Meeting 2012 on April 1. "It's not a remedy for poor planning."
- Emil J. Freireich, MD, DSc, director of the Adult Leukemia Research Program at MD Anderson Cancer Center, accepted an award as a 50-year AACR member on April 1 and gracefully reminisced about a paper he gave at an AACR meeting in 1964. Freireich wryly noted that the paper not only described the VAMP (vincristine, amethopterin, 6-MP, and prednisone) trial — a history-making chemotherapy treatment for childhood leukemia — but introduced the use of acronyms for such clinical trials.
- The antiangiogenic drug pazopanib (GlaxoSmithKline) has demonstrated clinically meaningful activity in patients with refractory urothelial cancer, according to results presented at the AACR conference by Andrea Necchi, MD, of Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy. Data from the phase II trial with 41 patients identify pazopanib as the first targeted compound to provide clinically meaningful activity. At follow-up, 7 patients had a partial response to therapy and 24 patients had stable disease. "Most interestingly, our biomarker analysis clearly pointed out the role of rising levels of circulating interleukin-8 as an early and potentially practice-changing indicator of tumor resistance and poor survival," Necchi added.
Also in the News
- Roche's antibody-drug conjugate trastuzumab emtansine (T-DM1) showed positive Phase III results for progression-free survival among women with human epidermal growth factor receptor 2–positive metastatic breast cancer who had previously received treatment with Herceptin and a taxane. The company did not give details about results from the 991-patient EMILIA trial but said it would do so at an upcoming meeting and would submit the drug for approval by the U.S. Food and Drug Administration and the European Medicines Agency later this year.
- Amazon Web Services has made the world's largest set of data on human genetic variation, created by the international 1000 Genomes Project, available for free on the Amazon Simple Storage Service. Currently totaling 200 terabytes, the data now being released on the cloud service (and already available on other free public sites) include DNA sequencing results from about 1,700 people.
- The latest "Annual Report to the Nation on the Status of Cancer" shows rates of death from all cancers continued to decline in the United States between 2004 and 2008. The report also finds that the overall rate of new cancer diagnoses for men and women combined decreased by less than 1% per year, on average, from 1998 through 2006, with rates leveling off from 2006 through 2008. The report was co-authored by researchers from the U.S. Centers for Disease Control and Prevention, the North American Association of Central Cancer Registries, the National Cancer Institute, and the American Cancer Society.
- The Cancer Prevention and Research Institute of Texas (CPRIT) announced more than $81 million in funding to support cancer research and commercialization in the state, including $20 million for a Houston-area pre-commercialization center to incubate promising cancer-focused technologies. The 25 newly funded projects bring the total amount of grants by CPRIT to more than $650 million since its inception in 2007.
March 29, 2012
- Seven types of human tumors transplanted into mice shrank or disappeared when scientists treated the animals with a single antibody that masks the CD47 protein, which protects cancer cells from macrophages and other immune cells. The anti-CD47 antibody treatment also blocked metastasis by highly aggressive tumors, according to a paper in PNAS. CD47 is normally expressed on the surfaces of circulating blood stem cells to protect them from macrophages, noted senior author Irving Weissman, MD, of the Stanford University School of Medicine.
- Under-reporting of potential heart damage from cancer drugs puts patients at an increased risk for heart failure, declared a commentary in the Journal of Clinical Oncology. "Clinicians need to know the full array of possible cardiac side effects so that they can monitor cardiac function appropriately and consider starting cardiac medications or holding the anticancer therapy altogether when necessary," said Ronald Witteles, MD, of Stanford University.
- In the BOLERO-2 phase III clinical trial among postmenopausal women with advanced breast cancer, combining everolimus (Afinitor; Novartis) and exemestane (Aromasin; Pfizer) treatment significantly improved bone strength and reduced the chances of bone metastasis. "These results indicate a new standard of care for women with advanced estrogen receptor–positive breast cancer that is resistant to hormonal therapy," Michael Gnant, MD, of the Medical University of Vienna told the 8th European Breast Cancer Conference.
- The U.S. Supreme Court set aside a ruling by the Federal Circuit Court of Appeals about the Myriad Genetics patents of BRCA1 and BRCA2 genes, and sent the case back to the lower court for further review.
- Memorial Sloan-Kettering Cancer Center and IBM are collaborating to build a decision-support tool based on the IBM Watson system (most famous for defeating humans on the Jeopardy quiz show) that will provide medical professionals with improved access to comprehensive cancer data and practices. Pilot applications for lung, breast, and prostate cancers will be released to a select group of oncologists late this year.
- Patients with a high risk of recurrence of a gastrointestinal stromal tumor who received imatinib (Gleevec; Novartis) for 3 years instead of 1 had markedly improved recurrence-free survival and overall survival, according to a study in JAMA.
- A personalized mouse "avatar," a mouse grafted with a patient's tumor tissue and treated with various agents, "makes it possible to try out different combinations and make some mistakes before going into the clinic," Edison Liu, MD, president of the Jackson Laboratory (Bar Harbor, ME) commented to Nature. "It's the direction in which a lot of research groups are going."
March 22, 2012
- South Korea's National Center for Cancer Genomics is launching a collaborative project to analyze breast cancer in Asian women. Genomic data from Asian patients will be compared to data in current International Cancer Genome Consortium (ICGC) programs led by France, the United Kingdom, and the United States.
- Additionally, the ICGC has made its eighth major data release, including first data releases from France's Liver Cancer project, Germany's Pediatric Brain Cancer project, and the United Kingdom's Myelodysplastic Syndrome project, plus updates from the Australian Pancreatic Cancer Project, Canadian Pancreatic Cancer project, Japanese Liver Cancer project, and the United Kingdom's Breast Cancer (Triple Negative) project. The ICGC says it has funding commitments for 47 project teams in 15 jurisdictions to study more than 18,000 tumor genomes.
- A U.S. Food and Drug Administration (FDA) advisory panel has recommended approval of GlaxoSmithKline's Votrient (pazopanib) to treat advanced soft-tissue sarcoma. The anti-angiogenesis drug received FDA approval in 2009 for treating advanced renal cell carcinoma.
- The first large-scale study of the relevance of circulating tumor cells (CTC) in early breast cancer prognosis has demonstrated that patients with at least 5 CTCs detected immediately after surgery have a 4-fold increase in risk of recurrence and a 3-fold increase in risk of death, according to a presentation at this week's eighth European Breast Cancer Conference (EBCC-8) in Vienna.
- The American Association for Cancer Research (AACR) has elected Charles L. Sawyers, MD, as president-elect for 2012–2013. Sawyers is chair of the Human Oncology and Pathogenesis Program at New York's Memorial Sloan-Kettering Cancer Center and a Howard Hughes Medical Institute investigator. Frank McCormick, PhD, director of the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, will be inaugurated as AACR president for 2012–2013 next month at the organization's 103rd annual meeting in Chicago.
- Women ages 21 to 65 should have a Pap smear every 3 years, according to new guidelines for cervical cancer screening from the U.S. Preventive Services Task Force (USPSTF) published in Annals of Internal Medicine. The guidelines say that women between ages 30 and 65 can safely extend the screening interval to once every 5 years if they undergo the human papillomavirus test at the same time as the Pap.
- The National Cancer Institute and the Cancer Institute/Hospital of the Chinese Academy of Medical Sciences (CICAMS) have signed a statement of intent to collaborate in biomedical research, as they have done for more than 30 years. Recently named China's National Cancer Center, CICAMS is now playing an expanded role in China's cancer prevention and control efforts.
March 15, 2012
- The 5-year survival rate for children and adolescents with acute lymphoblastic leukemia (ALL) improved to 90.4% for those diagnosed between 2000 and 2005 from 83.7% in those diagnosed between 1990 and 1994, according to a study in the Journal of Clinical Oncology. The 21,626 patients analyzed represented an estimated 55.8% of cases of ALL, the most common childhood cancer, diagnosed in the United States during this period. "I wonder how much more we could improve therapy for, say, breast cancer if half of all women with that disease were enrolled in clinical trials," commented lead author Stephen Hunger, MD, director of the Center for Cancer and Blood Disorders at Children's Hospital Colorado (Aurora, CO).
- An article in the Journal of the National Cancer Institute estimates that between 1975 and 2000, 2.1 million men and 1.1 million women died from lung cancer in the United States. The research suggests that 550,000 lung cancer deaths among men and 240,000 among women were averted by tobacco control efforts. In an accompanying editorial, Thomas J. Glynn, PhD, Director of Cancer Science and Trends and International Cancer Control at the American Cancer Society, declared that "We should use all of the tools at our disposal to rein in the rogue tobacco industry, and assiduously apply all of our political, research, advocacy, public health, and clinical skills to end tobacco's century of death, disease, and disability."
- Janssen Research & Development (Raritan, NJ) unblinded a phase III trial of Zytiga (abiraterone acetate) plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC) who have not received chemotherapy. After a planned interim analysis, the independent data monitoring committee recommended that patients in the placebo arm be offered treatment with the drug. Last year the U.S. Food and Drug Administration (FDA) approved Zytiga plus prednisone for men with metastatic CRPC who have received prior chemotherapy containing docetaxel.
- The American Society of Gene and Cell Therapy (ASGCT) has asked that individual gene therapy clinical trials no longer be reviewed by the federal Recombinant DNA Advisory Committee (RAC) because the proposals already are scrutinized by the FDA and institutional review boards. "After 20 years of testing and over 1,000 trials, no evidence exist at all to support the current regulatory burden the RAC request from gene transfer protocols," says ASGCT president-elect Xandra Breakefield, PhD, of Massachusetts General Hospital.
- The NIH's new National Center for Advancing Translational Sciences (NCATS) and Lilly Research Laboratories (Indianapolis, IN) have agreed that the NCATS Pharmaceutical Collection of 3,800 approved and investigational medicines will be screened with Lilly's Phenotypic Drug Discovery (PD2) panel, designed to reveal novel mechanisms or pathways of potential medicines for cancer and other diseases. The screening will take place over the next 18 months and results will be public at the NIH website: http://tripod.nih.gov/npc.
- Mersana Therapeutics (Cambridge, MA) will join with Endo Pharmaceuticals (Chadds Ford, PA) to create next-generation antibody-drug conjugates against one or more cancer targets. The deal includes an undisclosed upfront payment plus up to $270 million in milestone payments in addition to potential royalties.
- "Reducing the National Cancer Institute budget by $500 million and redistributing this money to fight Alzheimer's disease and diabetes might be more beneficial to overall health care in the U.S.," writes John LaMattina, former president of Pfizer Research and Development, in a commentary in Forbes. "At a time of tight budgets with no possibilities for increases in the near future, along with the enormous costs that other diseases are going to place on our healthcare system in the next decade, I believe that the NIH needs to revisit its funding priorities."
March 8, 2012
- NIH's National Center for Biotechnology Information has unveiled the Genetic Testing Registry, which collects voluntary submissions of genetic test information by providers. The database includes the test's purpose, methodology, analytic validity, clinical validity and utility, and laboratory contacts and credentials.
- The Impact of Personal Genomics Study will survey 1,000 consumers of personal genome testing to identify their motivations, expectations, and attitudes, as well as their responses to learning their genetic disease risk, carrier status, and drug-response results. Researchers from Brigham and Women's Hospital and the University of Michigan have teamed up with personal genome testing firms 23andMe (Mountain View, CA) and Pathway Genomics (San Diego, CA) for the study.
- The American College of Physicians has issued a new guidance statement for colorectal cancer screening based on individualized assessment of risk. It recommends that physicians screen for colorectal cancer in average-risk adults starting at the age of 50 and in high-risk adults starting at either the age of 40 or 10 years younger than the age at which the youngest affected relative was diagnosed with colorectal cancer.
- Dainippon Sumitomo Pharma of Osaka, Japan will buy Boston Biomedical Inc. (BBI) of Norwood, MA, for $200 million plus development milestones up to $540 million and commercial milestones up to $1.89 billion. BBI's BBI608 and BBI503 oral compounds are likely to become the first drugs in the world targeting cancer stem cells, according to Dainippon Sumitomo. BBI608 is in the preparatory stage for a phase III clinical trial for colorectal cancer in North America, and is in phase Ib and II clinical trials for various solid tumors.
- CYP2D6 genotypes that indicated reduced activity of enzymes that metabolize tamoxifen did not predict clinical responsiveness to adjuvant tamoxifen therapy among postmenopausal women with early-stage breast cancer, according to two studies in the Journal of the National Cancer Institute. CYP2D6 testing previously has been recommended to aid in deciding whether such patients should receive tamoxifen treatment. One study was led by researchers from the University of Michigan and the other by investigators from the Dana-Farber Cancer Institute and Emory University.
March 1, 2012
- A study by Italian and Swiss researchers estimates that 1.3 million people in the European Union (EU) will die from cancer in 2012. Although that figure would represent an increase in the actual number of cancer deaths, it would constitute a drop in the rate of cancer deaths of 10% in men and 7% in women compared with 2007 statistics. Published in the Annals of Oncology, the study examined overall cancer rates across the 27 EU member countries and in 6 individual countries—France, Germany, Italy, Poland, Spain, and the United Kingdom—for all cancers and separately for stomach, intestine, pancreas, lung, prostate, breast, uterine, and cervical cancers, and leukemias.
- A long-term study reported in the New England Journal of Medicine found that colonoscopy not only prevents colorectal cancer by removing polyps, but also prevents deaths from the disease. In follow-ups lasting as long as 23 years, researchers observed 2,602 patients who had precancerous polyps removed as part of the National Polyp Study. They concluded that detecting and removing the polyps led to a 53% reduction in colorectal cancer mortality.
- Based on recommendations issued last fall by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, the American Academy of Pediatrics says males age 11 and older should receive the Gardasil (HPV4; Merck) vaccine to protect them against HPV infections, which can cause genital warts as well as penile, anal, and oropharyngeal cancers.
- Dutch investigators reported that women who underwent the once-common CMF chemotherapy regimen for breast cancer between 1976 and 1995 scored slightly lower on cognitive tests than women who have never had cancer. (A combination of cyclophosphamide, methotrexate, and 5-fluorouracil, CMF has been replaced by other drug regimens.) The study published in the Journal of Clinical Oncology indicates that cognitive problems, which are known to occur shortly after treatment, may be observed decades later.
- The leukemia drugs nilotinib and imatinib could potentially reduce the spread of Ebola virus within the body, giving the immune system time to control the infection, according to an article in Science Translational Medicine.
- "We're seeing oncology drugs being systematically delayed from introduction and reimbursement" by government organizations such as the U.K.'s National Institute for Health and Clinical Excellence, GlaxoSmithKline chief executive Andrew Witty complained in an interview with the BBC. "We're seeing a variety of the more innovative, and yes more expensive medicines, being delayed in a whole series of different diseases across Europe."
February 23, 2012
- Oxford Nanopore Technologies has presented DNA sequence data using its nanopore "strand-sequencing" system, which is said to deliver ultra-long-read-length single-molecule sequence data with real-time results and competitive accuracy. The approach passes strands of DNA through nanopore protein channels and reads out DNA bases electronically. The Oxford, UK–based company plans to offer a range of scaleable commercial DNA sequencing systems this year, including a disposable device the size of a USB memory stick that is expected to retail for under $900. The company says that next year a high-end version of its scalable systems will be able to deliver a complete human genome in 15 minutes.
- Duke Cancer Institute celebrated the opening of the new Duke Cancer Center on February 22. The 7-story, 267,000-square-foot structure, designed to fully integrate cancer care and research, will include dedicated spaces where patients can speak with research nurses about available clinical trials.
- A new mouse reference library called the Collaborative Cross (CC) provides data on genetic variation contained in hundreds of specially bred mice. The publicly available CC mice have much more genetic variation than normal lab mice, and thus more closely mirror the genetic complexity found in humans, according to researchers who presented the resource this month in Genetics and G3:Genes/Genomes/Genetics.
- Researchers at Brown University have developed a self-assembling 3-dimensional living tissue glioma model complete with supporting blood vessels to examine the effects of cancer therapeutics, as described this month in Theranostics.
- Illumina of San Diego, CA, has launched a Cancer Analysis Service offered through the Illumina Genome Network, which links researchers needing large-scale, whole human genome sequencing services with institutions that provide these services.
- Gen-Probe, also of San Diego, says the U.S. Food and Drug Administration (FDA) has approved its Progensa PCA3 assay, the first molecular test to help assess the need for repeat prostate biopsies in men who have had a previous negative biopsy.
- Moffitt Cancer Center has received a patent for a computerized system that efficiently matches a cancer patient's molecular profile to specific targeted drugs. Moffit's for-profit subsidiary, M2Gen of Tampa, FL, will use the patent to support its business of gene-based trial matching.
- The FDA has agreed to allow temporary imports of drugs from abroad to ease critical shortages of 2 cancer therapies—doxorubicin (Doxil; Janssen) and methotrexate. Lipodox (Sun Pharma Global), which is similar to Doxil, will be shipped from India. Hospira is rushing 31,000 vials of preservative-free methotrexate to the United States from its Australia facility.
- Despite FDA actions, cancer drug shortages "will remain for the foreseeable future," says Jack Muckstadt, professor of engineering at Cornell University and the former director of Cornell's School of Operations Research and Industrial Engineering. "Simply put, there are no financial incentives for increasing capacity within or between manufacturers."
February 16, 2012
- Biotechnology firms received $4.7 billion in funding in 446 deals from U.S. venture capital in 2011, an increase of 22% in dollars and a drop of 9% in deals over the previous year, according to a report from PricewaterhouseCoopers and the National Venture Capital Association based on Thomson Reuters data. In the fourth quarter of 2011, early-stage funding for biotech soared to $797 million, a 110% climb from the same quarter in 2010.
- The U.S. Food and Drug Administration's Oncologic Drug Advisory panel voted against Amgen's Xgeva as a preventive measure for men who have recurring prostate cancer and are at high risk of developing bone metastases.
- Multiple cycles of fasting could potentially replace or augment the efficacy of certain chemotherapy drugs in the treatment of various cancers, according to studies in yeast, mammalian cell lines, and mouse models reported in Science Translational Medicine. In mice, 5 of 8 cancer types responded to fasting alone. "The combination of fasting cycles plus chemotherapy was either more or much more effective than chemo alone," said senior author Valter Longo, PhD, of the University of Southern California.
- On average, drugs developed by major pharmaceutical companies cost at least $4 billion and the total can exceed $11 billion, according to Matthew Herper of Forbes, after an analysis based on data from the InnoThink Center for Research in Biomedical Innovation. "The main expense," he added, "is failure."
- The President's Council of Advisors on Science and Technology says that the predicted shortfall of a million science, technology, engineering, and mathematics (STEM) graduates in the next decade can be met "with only a modest increase in the retention rate of STEM majors during the first few years of college." Today, fewer than 40% of students who enter college intending to major in a STEM field graduate with such a degree.
- BGI has opened its first European Genome Research Center in Copenhagen. One of the projects in the newest outpost of the world's largest genomics organization (formerly Beijing Genomics Institute) will be to identify and develop vaccines for previously unknown pathogens implicated in cancer.
- In designing clinical trials, "maybe we should engage the public in a discussion of what endpoint is 'meaningful,'" suggests Don S. Dizon, MD, FACP, on the ASCO Connection. "We are not only being called on to design 'smarter' trials. Our patients, living in an electronic age where information is at the fingertips, are calling on us to provide 'smarter' answers."
February 9, 2012
- The U.S. Food and Drug Administration has granted priority review for Genentech's pertuzumab in combination with trastuzumab (Herceptin; Genentech) and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous treatment or whose disease has relapsed after adjuvant therapy. The action date is June 8 for the application, which is based on results from the phase III CLEOPATRA study.
- The Norwegian Cancer Genomics Consortium is taking a step toward integrating next-generation genome sequencing into the country's health care system. In a 3-year pilot program, the group plans to prospectively sequence hundreds of genes in samples from 1,000 cancer patients as well as retrospectively studying 3,000 existing tumor samples.
- The aromatase inhibitor Exemestane (Aromasin; Pfizer), which has been demonstrated to prevent breast cancer in postmenopausal women at high risk of developing the disease, appears to significantly worsen age-related bone loss, according to an article in The Lancet Oncology. The results came from a substudy of the Mammary Prevention 3 (MAP.3) trial, which examined the effect of exemestane at preventing breast cancer in more than 4,500 healthy postmenopausal women at high risk of developing the disease and found that exemestane reduced the risk by 65% compared with placebo.
- Canada announced an initiative in research on personalized medicine for cancer and other illnesses. Funding of $67.5 million Canadian ($67.8 million U.S.) will come from Genome Canada, the Canadian Institutes of Health Research, and the Cancer Stem Cell Consortium. Investigators must obtain at least equal matching funding for their projects.
- Treatments with sorafenib (Nexavar; Bayer/Onyx Pharmaceuticals), sunitinib (Sutent; Pfizer), and pazopanib (Votrient; GlaxoSmithKline) have been linked to a slightly elevated chance of fatal adverse effects, in a meta-analysis in the Journal of Clinical Oncology.
- AB Science reported data from a phase II trial indicating that masitinib significantly improved overall survival for patients with imatinib–resistant gastrointestinal stromal tumors compared to sunitinib (Sutent; Pfizer), the current standard of care for these patients. After 2 years, 53% of 23 patients treated with masitinib were still alive, versus 0% of the 21 patients treated with sunitinib, the company said. Masitinib is a tyrosine kinase inhibitor that targets mast cells and certain kinases that play key roles in various cancers.
- The U.K. National Institute for Health and Clinical Excellence (NICE) has made a preliminary decision that the prostate cancer drug abiraterone (Zytiga; Johnson & Johnson) costs too much for use in the U.K. National Health Service.
February 2, 2012
- Celgene Corporation (Summit, NJ) will acquire Avila Therapeutics (Bedford, MA) for $350 million plus as much as $575 million more for meeting certain milestones. Avila is developing targeted drugs that treat diseases by covalently binding to disease-causing proteins. Its compound
AVL-292, a Bruton's tyrosine kinase (Btk) inhibitor, is currently in phase I clinical trials for hematologic cancers.
- The U.S. Food and Drug Administration (FDA) approved 2 new drugs: vismodegib (Erivedge; Genentech) for the treatment of basal cell carcinoma and axitinib (Inlyta; Pfizer) for the treatment of renal cell carcinoma. The agency also approved imatinib (Gleevec; Novartis) for expanded use in patients with gastrointestinal stromal tumors.
- Treatment with the investigational drug MDV3100 reduced the risk of death from late-stage prostate cancer by 37% compared with placebo in a phase III study of 1,200 men, the results of which were announced at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, February 2–4. Men treated with the drug had a median survival of 18.4 months, compared with 13.6 months for men who received a placebo. San Francisco's Medivation, the drug's manufacturer, will reportedly seek FDA approval for MDV3100 later this year.
- The Cambridge, MA, company Infinity Pharmaceuticals halted its randomized phase II clinical trial comparing saridegib
(IPI-926) plus gemcitabine to placebo plus gemcitabine in patients with metastatic pancreatic cancer. A preliminary analysis of the data showed that subjects in the gemcitabine arm lived longer than those in the saridegib plus gemcitabine arm. The company will continue trials of the drug in myelofibrosis and in chondrosarcoma.
- Amgen will buy the cancer drug development company Micromet for $1.16 billion. The purchase includes Micromet's top prospect, blinatumomab, a monoclonal antibody that is a bispecific T-cell engager under development for the treatment of acute lymphoblastic leukemia and non-Hodgkin lymphoma. Founded in Germany, Micromet's headquarters are located in Rockville, MD.
- The UK's Wellcome Trust Sanger Institute has launched an online survey to gather opinions about whether scientists should share genomic information with volunteers who provided blood or saliva samples for research purposes—information they do not typically receive. Survey responses will be used to guide policy on how genome research studies should be conducted in the future.
- A 4-week regimen with a dendritic cell vaccine targeting HER2 made with a patient's own cells eliminated tumors in nearly 20% of women with ductal carcinoma in situ, according to findings published in Cancer and the Journal of Immunotherapy. More than 85% of the women treated appear to have had a sustained immune response after vaccination, which may reduce their risk of developing a more invasive cancer in the future.
- In a hostile takeover bid, Roche Holding AG offered $5.7 billion for Illumina, Inc., a U.S. gene-sequencing equipment company. The world's largest manufacturer of oncology drugs, Roche would benefit from acquiring sequencing technology, which is central to personalized medicine.
January 26, 2012
- Overall success rates for NIH extramural research project grants have fallen to a record low of 18%, according to the NIH Data Book, recently updated with fiscal year 2011 data. The number of competing grant applications climbed 8% to a record high of 49,592. Average size of R01-equivalent grants increased slightly to $408,594. The representation of female investigators remains at 29% and their success rates for new applications were equal to those of male investigators at 15%.
- The Nebraska Medical Center and University of Nebraska Medical Center in Omaha plan to build a new cancer center with a 98-lab research tower for a total cost now estimated at $370 million. Construction dates have not been finalized for the center, which is being launched with the goal of becoming a National Cancer Institute Comprehensive Cancer Center by 2020.
- Single-agent treatment with Bayer's investigational drug regorafenib significantly improved survival and delayed cancer progression in patients with metastatic colorectal cancer that had progressed after standard therapies, according to a second interim analysis of a phase III trial reported at the 2012 Gastrointestinal Cancers Symposium in San Francisco. Among 760 patients, the median overall survival was 6.4 months for those given the oral multikinase inhibitor and 5.0 months for those given placebo.
- Another study presented at the 2012 Gastrointestinal Cancers Symposium showed that tests based on detecting the PAM4 protein in blood correctly identified 64% of patients with early-stage pancreatic ductal adenocarcinoma, which has historically been extremely difficult to uncover. The study examined sera from more than 600 patients with a mixture of malignant and benign diseases of the pancreas and surrounding tissues.
- Novartis's Sandoz subsidiary has begun 2 phase III clinical trials for biosimilars that target Amgen's Neupogen and Neulasta, which aid in accelerating neutrophil counts after chemotherapy. The trial for the Neupogen-like biosimilar is aimed at United States markets. Sandoz says it has at least 8 biosimilar molecules under development.
- Myriad Genetics, Inc., has licensed intellectual property covering the analysis of the RAD51C gene, whose mutations have been associated with an increased risk for hereditary breast and ovarian cancer. The Salt Lake City, Utah–based company has obtained an exclusive worldwide license, with co-exclusivity in Germany, to provide commercial testing for RAD51C.
January 19, 2012
- In patients with HER2-positive breast cancer, combining lapatinib (Tykerb; GlaxoSmithKline) with trastuzumab (Herceptin; Genentech) for neoadjuvant treatment with chemotherapy appears roughly twice as effective as either single-agent therapy, according to a report in The Lancet. The NeoAdjuvant Lapatinib and/or Trastuzumab Treatment Optimization (NeoALTTO) study enrolled 455 patients in 23 countries; more than half of those receiving combined anti-HER2 therapy achieved a pathologic complete response. An accompanying comment suggested that well-executed neoadjuvant trials "could lead to a saving of enormous sums in drug development costs, and promising new drugs for treatment of early breast cancer could become available much more quickly than at present."
- In an international phase III clinical trial, median length of survival for patients with metastatic colorectal cancer who were treated with Bayer's multi-kinase drug regorafenib increased from 5 months to 6.5 months, a statistically significant jump. This could be the first new therapy in recent years to result in improvement for such patients. The findings were presented this week at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology in San Francisco by Mayo Clinic oncologist Axel Grothey, MD.
- The U.S. Food and Drug Administration (FDA) has asked Congress to approve a user fee program (similar to programs for new and generic drugs) for an abbreviated regulatory approval pathway for biosimilar agents.
- Research results from the St. Jude Children's Research Hospital and Washington University Pediatric Cancer Genome Project (PCGP) are now posted on a free website. The PCGP is said to be the largest current effort aimed at whole-genome sequencing of both normal and cancer cells from pediatric cancer patients.
- Among 282 medicines for children and adolescents by U.S. biopharmaceutical companies that are in clinical trials or FDA review, 54 target cancer, according to a survey by the Pharmaceutical Research and Manufacturers of America.
- Researchers at the United Kingdom Medical Research Council's Cancer Cell Unit and New York University have discovered a mechanism for identifying Barrett's dysplasia cells by spraying on a fluorescent probe with a wheat-germ protein that sticks to sugars and lights up abnormal areas during endoscopy, according to a report in Nature Medicine.
January 12, 2012
- Life Technology Corp. of Carlsbad, CA, is taking orders for a $149,000 sequencer that sits on a bench and is designed to sequence the entire human genome in a day for $1,000. "The technological advances in the new Ion Proton instrument promise to be game-changing for both research and clinical applications," commented Richard Lifton, MD, PhD, chair of the Department of Genetics at Yale School of Medicine. "Just 6 months after our first semiconductor sequencing chip was released, people used it to solve the German E. coli outbreak, sequencing the toxic strain in just a couple of hours," said Jonathan Rothberg, PhD, founder and CEO of Life Technology's Ion Torrent division. "Now, 6 months later we're developing a chip that's 1,000 times more powerful than that to sequence an entire human genome in about the same amount of time."
- Men who were screened annually for prostate cancer had no evidence of a mortality benefit compared to a control group over a 13-year period, according to a study published in the Journal of the National Cancer Institute and drawn from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening trial.
- Scientists have discovered the first major genetic variant associated with inherited prostate cancer, as reported in The New England Journal of Medicine. The study indicated that men who inherit a HOXB13 gene mutation have a 10- to 20-times higher risk of developing prostate cancer.
- Genetic alterations fueling a subtype of acute lymphoblastic leukemia (ALL) known as early T-cell precursor ALL (ETP-ALL) and characterized by a poor prognosis may have more in common with acute myeloid leukemia than with other subtypes of ALL, according to a study in Nature.
- MD Anderson Cancer Center's historic Houston Medical Building was brought down by implosion on January 8. The University of Texas acquired the 20-story structure in 1974.
January 5, 2012
- Overall U.S. cancer incidence rates declined by 0.6% per year in men and were stable in women between 2004 and 2008, while cancer death rates decreased by 1.8% per year in men and by 1.6% per year in women, according to the American Cancer Society's annual statistics report. But the incidence of several cancers has increased in the past decade, including cancers of the pancreas, liver, thyroid, and kidney, and melanoma of the skin, as well as esophageal adenocarcinoma and certain types of oropharyngeal cancer associated with human papillomavirus infection. A total of 1.634 million new cancer cases and 577,000 deaths from cancer are projected to occur in the United States in 2012.
- Several papers published this week in the British Medical Journal (BMJ) look at the extent, causes, and consequences of unpublished evidence from clinical trials. A BMJ editorial outlines a "culture of haphazard publication and incomplete data disclosure," and one study found that incorporating unpublished data in published meta-analyses of drug trials often changes their results.
- Researchers at the National Cancer Institute have used quantitative high-throughput screening with the NIH Chemical Genomic Center's complete pharmaceutical collection to identify agents with an antiproliferative effect in thyroid cancer cell lines, according to a report in the Journal of Clinical Endocrinology & Metabolism. The newly assembled collection contains 2,816 approved drugs and bioactive compounds.
- Cancer Genetics Inc. plans to make an initial public offering of up to $50 million. The Rutherford, NJ, company provides cancer diagnostic and prognostic tools, including a microarray tailored for detecting chronic lymphocytic leukemia.
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