Noted This Week
Cancer-related news briefs by week
March 17, 2017
- President Donald Trump released his proposed budget for fiscal year (FY) 2018, calling for an increase of $54 billion in defense spending. To pay for that without adding to the federal deficit, he suggests cutting allocations to a number of agencies and programs, including the NIH, which would see its budget slashed by $5.8 billion, about 20% of its current funding. Although no specifics were provided, the proposal also calls for “a major reorganization of NIH’s Institutes and Centers to help focus resources on the highest priority research and training activities.”
- President Trump nominated Scott Gottlieb, MD, to lead the FDA. Currently, Gottlieb is a health policy analyst and fellow at the conservative American Enterprise Institute, where he has studied the FDA and the Centers for Medicare and Medicaid Services. Previously, he served as deputy commissioner for medical and scientific affairs at the FDA.
- The FDA gave its stamp of approval to ribociclib (Kisqali; Novartis) as a first-line treatment for HR-positive, HER2-negative metastatic breast cancer in combination with an aromatase inhibitor such as letrozole. A CDK4/6 inhibitor, ribociclib was approved based on interim data from a phase III trial showing a 44% reduction in the risk of disease progression or death after 18 months of treatment. A subsequent analysis determined that the progression-free survival for ribociclib plus letrozole was 25.3 months compared with 16 months for letrozole alone.
- The FDA also approved the use of pembrolizumab (Keytruda; Merck) to treat children and adults with refractory classical Hodgkin lymphoma, as well as patients whose disease has returned after three or more prior therapies. The decision was based upon a multicenter, nonrandomized, open-label trial involving 210 patients, which yielded an overall response rate of 69%. The anti–PD-1 immunotherapy is already indicated for certain melanomas, non–small cell lung cancers, and head and neck squamous cell carcinomas.
- Under new rules issued by the Accreditation Council for Graduate Medical Education (ACGME), work hours for all medical residents will be capped at 80 hours a week, with shifts limited to 24 hours plus an additional 4 hours “to manage necessary care transitions.” The change, which goes into effect on July 1, will improve patient safety by reducing the number of times that one physician hands off patient care to another, according to the ACGME. The maximum shift duration for first-year residents had been set at 16 hours in 2011.
- The U.S. Preventive Services Task Force posted its Draft Research Plan on Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer. The plan is available for review and public comment until April 12. The plan guides a systematic review of evidence, which will be drawn upon to evaluate the benefits and harms of these clinical services and develop specific recommendations for their use.
March 10, 2017
- Personalized medicine can improve patients’ health and reduce medical expenses, yet multiple challenges are slowing broad implementation of the practice, which involves matching patients to therapies based on the molecular characteristics of their tumors, according to a report from The Personalized Medicine Coalition. Titled “The Personalized Medicine Report: Opportunity, Challenges, and the Future,” the report says that the lack of standardization in the review of laboratory-developed tests, questions about regulatory oversight of next-generation sequencing, reimbursement concerns, and the need to increase awareness among patients and healthcare providers about the value of personalized medicine have stymied its adoption.
- According to an audit, a project involving IBM’s Watson and The University of Texas MD Anderson Cancer Center in Houston has made little progress in using the technology to transform clinical care after almost 5 years of work and an investment of $62 million by the institution. The audit, according to The Wall Street Journal, found that “technology challenges at MD Anderson … made it hard to integrate artificial-intelligence software into complicated health-care settings,” and that the pilot program didn’t work with the hospital’s electronic health records. The audit didn’t assess Watson’s ability to learn from scientific data and publications and then recommend appropriate treatment options for patients.
- The FDA lifted a clinical hold on studies of the leukemia drug vadastuximab talirine (Seattle Genetics) after an analysis of data collected on about 300 patients and some changes to study protocols. The hold was implemented in December after four clinical-trial participants died.
- Using data from the Surveillance, Epidemiology, and End Results (SEER) database, researchers have found that deaths from childhood cancer may be nearly four times more common than previously thought. Writing in the Journal of Clinical Oncology, they point to a clinical trial involving children with acute myeloid leukemia in which 1.6% of patients died. In contrast, records in the SEER database show that about 6.2% of young patients die of the disease, noting that these children—especially those who haven’t reached their first birthday—often don’t live long enough to receive treatment or enroll in a clinical trial.
- In a multicenter, randomized phase III trial, patients with high-risk chronic lymphocytic leukemia were significantly more likely to respond to the combination of ublituximab (TG-1101) plus ibrutinib (Imbruvica; Pharmacyclics, Janssen) than ibrutinib alone, TG Therapeutics announced. (“High risk” was defined as having a 17p deletion, an 11q deletion and/or a p53 mutation.) Among 117 treated patients, 80% of those who received the combination responded, compared with 47% of those receiving ibrutinib alone. Ublituximab is a glycoengineered anti-CD20 monoclonal antibody.
March 3, 2017
- Kite Pharma announced positive data from a pivotal phase II trial evaluating its lead chimeric antigen receptor T-cell therapy, axicabtagene ciloleucel, in non–Hodgkin lymphoma (NHL). Among 101 patients with multiple types of aggressive NHL, each given a single infusion of the CD19-targeting cells, the objective response rate was 82%, of which 54% were complete responses; the median overall survival (OS) has not been reached. Based on these results, the Santa Monica, CA–based company intends to seek FDA approval of axicabtagene ciloleucel later this year.
- The NCI launched its largest study, to date, of African American cancer survivors. Through interviews, information from medical records, and biospecimen collection, the Detroit Research on Cancer Survivors study—funded by a 5-year, $9 million grant—will acquire comprehensive data on 5,560 cancer survivors in three counties surrounding Detroit, MI.
- San Diego, CA–based OncoSec Medical Inc. received the FDA’s Fast Track designation for developing ImmunoPulse IL-12 to treat patients with metastatic melanoma who have progressed on pembrolizumab (Keytruda; Merck) or nivolumab (Opdivo; Bristol-Myers Squibb). ImmunoPulse is designed to stimulate expression of IL12 in the tumor microenvironment, thereby potentially converting tumors from being immunologically “cold” to “hot.”
- The FDA granted Priority Review to two investigational agents, enasidenib (Celgene) and avelumab (Pfizer, EMD Serono), for relapsed/refractory acute myeloid leukemia (AML) and locally advanced or metastatic urothelial carcinoma, respectively. Enasidenib is a first-in-class targeted inhibitor of mutant IDH2, which occurs in 8% to 19% of AML cases; avelumab targets the PD-L1 ligand in the PD-1 immune checkpoint pathway. The agency’s approval decisions are expected by the end of August.
- According to a Journal of the National Cancer Institute study, rates of colon and rectal cancers are rising among young adults in the United States. “Compared with adults born circa 1950, those born circa 1990 have double the risk of colon cancer and quadruple the risk of rectal cancer,” the researchers report. Obesity, sedentary behavior, and diet are among the probable culprits; the findings suggest that some screening tests may need to begin before the age of 50, which is the age currently recommended for the average individual.
- Amgen reported positive results from a phase III trial comparing its proteasome inhibitor carfilzomib (Kyprolis) with Takeda’s bortezomib (Velcade) in relapsed/refractory multiple myeloma. Among patients randomly assigned to receive either drug plus dexamethasone, the median OS was 47.6 months in the carfilzomib arm, versus 40 months for those given bortezomib. Bortezomib has long been the standard of care, but these results support carfilzomib as the treatment of choice in this patient population, the company says.
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