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Noted This Week - Archive 2021

Noted This Week - 2021 Archive

Archive of cancer-related news briefs, by week, for 2021

April 2021

April 23–29

  • The FDA's Oncologic Drugs Advisory Committee voted to maintain accelerated approvals for four of six immunotherapy indications that were under review. The favorable votes were for the use of pembrolizumab (Keytruda; Merck) in hepatocellular carcinoma and urothelial carcinoma, and atezolizumab (Tecentriq; Genentech) in triple-negative breast cancer and urothelial carcinoma; the committee voted against pembrolizumab to treat gastric cancer and nivolumab (Opdivo; Bristol Myers Squibb) to treat hepatocellular carcinoma. The FDA doesn’t need to follow the committee's recommendation, although it usually does so.
  • The FDA granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics) in patients with relapsed/refractory large B-cell lymphoma who have received at least two other therapies. The approval was based on the phase II LOTIS-2 trial, in which patients had an overall response rate of 48.3% and a median duration of response of 10.3 months. The agent is a CD19-targeting antibody–drug conjugate.
  • The agency also announced it plans to ban menthol cigarettes and all flavored cigars within the next year. "Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products," said Acting FDA Commissioner Janet Woodcock, MD, noting higher rates of use among communities of color, people with low income, and LGBTQ+ individuals.
  • The FDA issued a Notice of Noncompliance to Acceleron Pharma for not reporting trial results to clinicaltrials.gov. The company now has 30 days to upload findings to the site, after which it could be fined up to $10,000 per day. The notice is the first issued by the FDA to enforce a Health and Human Services Department rule finalized in 2016, although the agency has sent more than 40 warnings to other companies.

Earlier This Year:

 ::  January  ::  February  ::  March

Noted This Week Archive:

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  • Young men are less likely to receive the human papillomavirus vaccine than young women, researchers reported (JAMA 2021;325:1673–4). Researchers reviewed vaccination data for 18- to 21-year-olds gathered by the National Health Interview Survey from 2010 to 2018. They found that, overall, 42% of females and 16% of males received at least one dose of the vaccine; in 2010, 32% of females and 2% of males received at least one dose, compared with 55% and 34%, respectively, in 2018.
  • Galera announced that avasopasem (GC4419) may improve the effectiveness of stereotactic body radiation in patients with locally advanced pancreatic cancer. In a phase I/II trial, patients treated with the agent plus radiotherapy had a median overall survival of 20.1 months and a response rate of 29%, compared with 10.9 months and 11% in patients who received radiotherapy alone. Avasopasem is a dismutase mimetic designed to convert superoxide into hydrogen peroxide and oxygen, thus protecting normal tissue from damage during radiotherapy.

April 16–22

  • The FDA granted accelerated approval to dostarlimab-gxly (Jemperli; GlaxoSmithKline) for patients with mismatch repair–deficient recurrent or advanced endometrial cancer who have already received chemotherapy. The approval of the PD-1 inhibitor was based on the single-arm GARNET trial, in which patients had an overall response rate of 42.3%, and 93.3% of patients responded for at least 6 months.
  • Bristol Myers Squibb announced that the FDA approved nivolumab (Opdivo) plus chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma—regardless of PD-L1 expression. The PD-1 inhibitor’s approval was based on the CHECKMATE-649 trial, in which patients treated with the combination had a median progression-free survival (PFS) of 7.7 months and a median overall survival (OS) of 14.4 months, compared with 6 months and 11.1 months, respectively, in patients who received chemotherapy alone.
  • The antibody–drug conjugate sacituzumab govitecan (Trodelvy; Immunomedics) may be effective in patients with relapsed/refractory triple-negative breast cancer (N Engl J Med 2021;384:1529–41). In the phase III ASCENT trial, patients treated with the agent had a median PFS of 5.6 months and a median OS of 12.1 months, compared with 1.7 months and 6.7 months, respectively, in patients who received chemotherapy. The FDA recently approved sacituzumab govitecan to treat these patients.
  • According to results of the ongoing phase I/II AUGMENT-101 trial, the menin inhibitor SNDX-5613 (Syndax) may be effective in patients with MLL rearranged or NPM1 mutant relapsed/refractory acute leukemias. In the trial, 15 of 31 evaluable patients responded to the drug, and 10 responders were minimal residual disease–negative; responses were seen in 13 of 24 patients with MLL rearranged disease.
  • A group of public and private cancer organizations announced the formation of a Multi-Cancer Early Detection Consortium. The consortium will evaluate the clinical and public health value of new cancer detection technologies and establish standards for using such technologies in routine medical care. More than 35 organizations have joined so far; founding members include Dana-Farber Cancer Institute in Boston, MA, Stand Up To Cancer, and Grail, among others.
  • Researchers launched the DiRECT study to investigate racial differences in response to immune checkpoint inhibitors. Led by New York’s Roswell Park Comprehensive Cancer Center in Buffalo and Wilmot Cancer Institute at the University of Rochester Medical Center, the study aims to enroll 600 Black patients and 1,200 white patients of European ancestry treated with immunotherapy. The project is supported by a 2-year, $2.08 million NCI grant.
  • Janssen Pharmaceuticals will not pursue FDA approval of the androgen receptor inhibitor apalutamide (Erleada) plus abiraterone acetate (Zytiga) and prednisone in patients with metastatic castration-resistant prostate cancer who have not received chemotherapy. The decision came after the triplet failed to improve OS compared with abiraterone acetate and prednisone alone in the phase III ACIS trial.

April 9–15
This week: Special content from the AACR Annual Meeting 2021 and other news

  • NCI Director Norman "Ned" Sharpless told attendees of the American Association for Cancer Research (AACR) Annual Meeting 2021 that progress must speed up dramatically. To cut the cancer mortality rate in half from its peak in the early 1990s, "will require a considerable acceleration of what we’ve been able to achieve in the last few decades," he said. At the current rate of 2.2% per year, it would take until 2040 to reach that goal—"that’s too long… Using all of our many tools of prevention and screening and new therapies, I think we can get there by 2026—that’s 5 years from now. This would require an average reduction in cancer mortality of about 4% per year, which is considerably faster than the rate of decline we’ve ever done before."
  • In a high-level outline of its budget priorities for fiscal year 2022 released on April 9, the Biden Administration proposed a total increase of $9 billion for the NIH. Of that, $2.5 billion would be distributed to the NIH’s various institutes, of which the NCI is the largest, Sharpless reported. If approved by Congress, "that would translate into a substantial increase in the NCI’s budget for FY2022. This would be key to allowing the NCI to continue to increase paylines and success rates for grant applications."
  • Aiming to cure major diseases, including cancer and diabetes, the Biden Administration proposed creating a $6.5 billion medical research agency that would be "housed" within the NIH. The Advanced Research Projects Authority for Health would be modeled after the Defense Advanced Research Projects Agency, wherein funding decisions are made by program managers rather than peer reviewers, and projects receive milestone-driven payments instead of multiyear grants.
  • During the AACR meeting, Melissa Davis, PhD, of Weill Cornell Medical College in New York, NY, discussed how a lack of genomic data from diverse populations can lead to disparities in cancer research. "Just about any population that is of non-European descent has a higher rate of reporting back on a mutation panel a variant of unknown significance," she said. These panels are used to determine eligibility for trials, she added, so "if their mutations are undefined and therefore by definition unknown and unactionable, this a systematic exclusion of these individuals for their access to trials."
  • The director of the Cold Spring Harbor Laboratory Cancer Center in New York, David Tuveson, MD, PhD, was inaugurated as president of the AACR on April 12, succeeding Antoni Ribas, MD, PhD, of the University of California, Los Angeles, Jonsson Comprehensive Cancer Center. Lisa Coussens, PhD, of the Knight Cancer Institute at Oregon Health & Science University in Portland, will become the organization’s president following Tuveson’s 1-year term.
  • At the AACR meeting, Eric Klein, MD, of Ohio’s Cleveland Clinic reported data from a prospective study on Galleri, GRAIL’s multicancer early detection test. Researchers assessed Galleri, which relies on sequencing of methylation regions in circulating cell-free DNA to detect malignancies, on 2,823 patients with cancer and 1,254 healthy people. The assay had a specificity of 99.5% and a sensitivity of 51.5% across cancer types and stages; sensitivity increased with cancer stage. Among patients who tested positive for cancer, Galleri accurately determined the tissue of origin in 88.7% of cases. "These data support the foundation for population-scale clinical implementation of this test," Klein concluded.
  • Engineered natural killer (NK) cells can target specific antigens via expression of chimeric antigen receptors (CAR). As an alternative approach to endow NK cells with CAR-like activity, Katayoun Rezvani, MD, PhD, of The University of Texas MD Anderson Cancer Center in Houston, reported the generation of cord blood–derived NK cells precomplexed prior to infusion with AFM13 (Affimed), a bispecific innate cell engager that binds CD16 on NK cells and CD30 on tumor cells. Preliminary results from a phase I trial indicate that adoptive transfer of AFM13-complexed CAR-like NK cells shows antitumor activity with minimal toxicity in patients with relapsed/refractory CD30+ Hodgkin lymphoma.
  • Tumor heterogeneity can make it difficult to determine which tumors are immunologically "hot" and thus more likely to respond to immunotherapy. Elisabeth De Vries, MD, PhD, and colleagues at the University Medical Center Groningen in the Netherlands explored whole-body PET imaging and reported that tumor uptake of radiolabeled PD-1 antibodies is associated with prolonged progression-free and overall survival. "Whole body information about what’s happening at the tumor and normal tissue level might provide insights into what’s happening during the complex processes induced by immunotherapy," she told AACR meeting attendees.
  • Also at the AACR meeting, Ross Levine, MD, of Memorial Sloan Kettering Cancer Center in New York, NY, outlined studies demonstrating the power of single-cell sequencing technology to precisely identify the timing of mutations and define clonal trajectories. Follow-up studies have shown that clonal genotypes are associated with distinct immunophenotypes, he said, and advances in in vivo modeling and multi-omics single-cell sequencing will provide insight into the mechanisms underlying evolutionary mutational trajectories and enable elucidation of the biological underpinnings of clonal hematopoiesis.
  • Michel Sadelain, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, NY, described several advances in chimeric antigen receptor (CAR) T-cell therapy that might improve its efficacy—modulation of transcriptional regulation, signaling calibration, and epigenetic enhancement. He also introduced a novel CAR design called HIT receptor and demonstrated its greater antigen sensitivity compared with "traditional" CAR T-cell therapy.
  • The 4-1BB (CD137)/HER2 bispecific cinrebafusp alfa (PRS-343; Pieris) may be active in patients with HER2-expressing cancers who have previously received multiple therapies. In a phase I trial presented at the AACR meeting, five of 42 evaluable patients responded to the therapy, and 17 more patients experienced stable disease; two of the responses—including one complete response—were in eight patients treated at the highest dose level. The agent increased CD8+ T cells, NK cells, and cytotoxic activity in the tumor microenvironment.
  • Researchers described the discovery of INCB89550, a PD1/PD-L1 inhibitor at the AACR meeting that is being tested in clinical trials. Using high-throughput screening, the team initially identified a compound that exhibited dose-dependent inhibition of PD-1–PD-L1 interactions. Analysis of the amino acid residues critical for drug activity revealed that the inhibitor blocked binding by interacting with PD-L1 directly at the PD-1–PD-L1 binding interface—a rare occurrence because this interface is largely flat and lacks a defined binding pocket. The researchers then used rational, structure-guided design of improved inhibitors derived from the initial hit to identify INCB086550 as a candidate for clinical development.
  • Also at the AACR meeting, researchers reported promising preclinical results for the targeted thorium conjugate HER2-TTC (BAY2701439; Bayer). The agent consists of a radioactive thorium isotope bound by a chelator that is covalently linked to a HER2 antibody. It kills HER2-expressing cells and neighboring cells by delivering alpha radiation that induces DNA damage—for which there is no known resistance mechanism. Preclinical results suggest that HER2-TTC may have anti-tumor activity in cancers with low levels of HER2 expression, as well as those that are resistant to other HER2-targeted agents. The agent is now being tested in a phase I trial of HER2-expressing malignancies.

  • In other news:

  • The FDA authorized the marketing of the artificial intelligence device GI Genius (Cosmo Artificial Intelligence), which assists clinicians in detecting lesions during a colonoscopy. In a prospective trial of patients with adenoma or carcinoma, the technology identified lesions in 55.1% of cases, compared with a 42% detection rate for colonoscopy alone. The device, which uses a machine learning algorithm, attaches to an endoscope and identifies regions of interest in the colon, alerting clinicians to take a closer look.
  • The agency also granted accelerated approval to sacituzumab govitecan (Trodelvy; Immunomedics), an antibody–drug conjugate, for patients with locally advanced or metastatic urothelial cancer who have received chemotherapy and a PD1/PD-L1 inhibitor. The approval was based on the phase II TROPHY trial, in which patients had an objective response rate of 27.7% and a median duration of response of 7.2 months.
  • GlaxoSmithKline (GSK) halted the phase II INDUCE-3 trial testing feladilimab, an inducible T-cell co-stimulatory agonist, plus pembrolizumab (Keytruda; Merck) in head and neck cancer based on the recommendation of an independent data monitoring committee. The company will also discontinue the phase II INDUCE-4 trial assessing feladilimab plus pembrolizumab and chemotherapy in head and neck cancer. GSK did not share details of the committee’s recommendation.

April 2–8

  • Daiichi Sankyo announced it will invest $13.6 billion in new cancer treatments through March 2026, an investment that represents a nearly 70% increase over the previous 5-year period. The company aims to expand the uses for the HER2-targeted antibody–drug conjugate (ADC) trastuzumab deruxtecan (Enhertu), jointly developed with AstraZeneca, beyond breast and gastrointestinal cancers. Also, the company plans to develop other ADCs, including TROP2- and HER3-targeting agents.
  • Researchers suggested that eligibility criteria for some cancer clinical trials could be expanded (Nature 2021 Apr 7 [Epub ahead of print]). They used an artificial intelligence tool called Trial Pathfinder to emulate clinical trials based on electronic health records of 61,094 patients with advanced non–small cell lung cancer. When they broadened enrollment criteria for these hypothetical trials, they found that the pool of eligible patients more than doubled on average, while overall survival (OS) decreased minimally.
  • The FDA upgraded sacituzumab govitecan-hziy’s (Trodelvy; Gilead) accelerated approval to a full approval in patients with locally advanced or metastatic triple-negative breast cancer who aren’t eligible for surgery and have already received at least two therapies. The decision was based on the phase III ASCENT trial, in which the agent led to a median progression-free survival of 4.8 months and a median OS of 11.8 months, compared with 1.7 months and 6.9 months, respectively, in patients who received chemotherapy. Sacituzumab govitecan-hziy consists of a monoclonal antibody against human trophoblast cell-surface antigen 2 conjugated to the topoisomerase I inhibitor SN-38.
  • The agency also approved a biweekly dosing regimen for the EGFR inhibitor cetuximab (Erbitux; ImClone) in patients with EGFR-mutant colorectal cancer or head and neck cancer. The approval was based on pharmacokinetic and real-world data suggesting that patients derive a similar benefit whether they are treated with the drug weekly or receive a larger dose every 2 weeks.
  • Researchers projected that the landscape of cancer incidence and mortality in the United States will change considerably by 2040 (JAMA Network Open 2021;4:e214708). Notably, melanoma incidence will increase, whereas prostate cancer incidence will drop. Additionally, there will be more deaths from pancreatic and liver cancers and fewer deaths from breast cancer. Estimates were made by combining data from the Surveillance, Epidemiology, and End Results Program with projections from the U.S. Census Bureau.

March 2021

March 26–April 1

  • The Federal Trade Commission will seek to stop Illumina’s $7.1 billion acquisition of Grail. The government agency claims that the deal will inhibit the market for blood-based cancer detection tests because Illumina is the only provider of DNA sequencing for such tests. Grail was founded by Illumina in 2016 and later became a stand-alone company.
  • The FDA approved idecabtagene vicleucel (ide-cel, Abecma; Bristol Myers Squibb) for patients with relapsed/refractory multiple myeloma who have already received at least four therapies. In the phase III KarMMA trial, the agent elicited an overall response rate of 72% and a median duration of response of 11 months. Idecabtagene vicleucel is a chimeric antigen receptor (CAR) T-cell therapy that targets B-cell maturation antigen; it is the first CAR T-cell therapy to be approved in multiple myeloma.
  • The agency also approved isatuximab-irfc (Sarclisa; Sanofi) plus carfilzomib (Kyprolis; Amgen) and dexamethasone in relapsed/refractory multiple myeloma. The approval was based on positive results in the phase III IKEMA trial: Patients treated with the triplet did not reach median progression-free survival, compared with 20.3 months in those who received carfilzomib plus dexamethasone. The approval is the first for isatuximab-irfc, a CD38-directed cytolytic antibody.
  • Jazz Pharmaceuticals announced that the FDA expanded the indication for daunorubicin and cytarabine (Vyxeos) to include children age 1 and older newly diagnosed with therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes. The approval was supported by two single-arm trials, AAML 1421 and CPX-MA-1201, in which there were no age-related differences in safety. The agent, a combination of a nucleoside metabolic inhibitor and an anthracycline topoisomerase inhibitor, was approved for adults with AML in 2017.
  • Adjuvant nivolumab (Opdivo; Bristol Myers Squibb) may be effective in esophageal and gastroesophageal junction cancer (N Engl J Med 2021;384:1191–203). In the phase III CheckMate-557 trial, patients treated with the PD-1 inhibitor had a median disease-free survival of 22.4 months compared with 11 months in those who received a placebo.
  • A survey conducted by the American Society for Radiation Oncology found that the COVID-19 pandemic may be causing cancers to be diagnosed at later stages. Sixty-six percent of radiation oncologists said patients are being diagnosed with more advanced cancers than prior to the pandemic, and 73% said patients at their practices are not receiving cancer screenings. Additionally, 66% said patients with cancer have experienced an interruption in radiation therapy.

March 19–25

  • The FDA approved the PD-1 inhibitor pembrolizumab (Keytruda; Merck) plus chemotherapy in patients newly diagnosed with locally advanced or metastatic esophageal junction carcinoma who are not eligible for surgery or chemoradiation. The approval was based on the phase III KEYNOTE-590 trial, in which patients treated with the combination had a median progression-free survival (PFS) of 6.3 months and a median overall survival (OS) of 12.4 months, compared with 5.8 months and 9.8 months, respectively, in patients who received only chemotherapy.
  • Pembrolizumab plus the VEGF inhibitor lenvatinib (Lenvima; Merck) may improve survival in advanced, metastatic, or recurrent endometrial cancer, according to findings presented at the Society of Gynecologic Oncology 2021 Annual Meeting on Women’s Cancer, held virtually March 19–25. In the phase III KEYNOTE-775/Study 309 trial, patients treated with the combination had a median PFS of 7.2 months and a median OS of 18.3 months, compared with 3.8 months and 11.4 months, respectively, in patients who received standard chemotherapy.
  • Novartis announced that the radionuclide 177Lu-PSMA-617 may be effective in patients with metastatic castration-resistant prostate cancer that expresses prostate-specific membrane antigen. In the phase III VISION trial, the agent extended OS and radiographic PFS compared with standard chemotherapy, although the company did not share any data. In a phase II trial, the drug led to a higher objective response rate and prostate-specific antigen response than chemotherapy (The Lancet 2021;397:797–804).
  • Researchers from the COVID-19 and Cancer Consortium reported that Black and Hispanic patients tend to develop more severe COVID-19 infections than white patients (Ann Oncol 2021 Mar 18 [Epub ahead of print]). That conclusion was based on data from 4,966 patients with cancer who developed COVID-19 infections between March and November 2020. Other risk factors associated with more severe COVID-19 included older age, obesity, being male, and comorbidities.
  • Stand Up To Cancer (SU2C) awarded $6 million to a team studying health equity in cancer research. The SU2C Health Equity Breakthrough Team will address underrepresentation of Black and indigenous populations, and people of color in breast, prostate, and liver cancer trials by working with community organizations, training scientists and doctors, and exploring better ways to educate these patients. The team is part of SU2C’s Health Equity Initiative, which launched in January 2020.

March 12–18

  • Sanofi and Regeneron announced that a phase III trial testing cemiplimab (Libtayo) in recurrent or metastatic cervical cancer will be stopped early due to positive results. The decision was made because patients treated with the agent experienced a statistically significant improvement in median overall survival compared with those who received chemotherapy: 12 months versus 8.5 months, respectively. A PD-1 inhibitor, cemiplimab is FDA approved for certain forms of basal cell carcinoma and non–small cell lung cancer.
  • Bintrafusp alfa (GlaxoSmithKline/Merck KGaA) may not be effective as a second-line therapy for patients with locally advanced or metastatic biliary tract cancer (BTC) who have received platinum-based chemotherapy. In a phase II trial, the agent elicited an objective response rate of 10.1%, which failed to meet the predefined threshold for efficacy. A bifunctional fusion protein that blocks TGFβ and PD-L1, bintrafusp alfa will continue to be tested in combination with chemotherapy in BTC.
  • Socioeconomically disadvantaged patients enrolled in cancer clinical trials may fare worse than their more affluent counterparts despite receiving high-quality care during the trials (J Clin Oncol 2021 Mar 17 [Epub ahead of print]). Researchers analyzed data from 41,109 patients with cancer enrolled in 55 phase II and III trials between 1985 and 2012. They found that patients from the poorest neighborhoods had a 28% increased risk of death compared with those from the most affluent areas.
  • A survey revealed that disposable electronic cigarettes (e-cigarettes) are becoming increasingly popular among kids (NEJM 2021 Mar 16 [Epub ahead of print]). Researchers analyzed responses from middle school and high school students gathered during 2019 and 2020. They found that among current e-cigarette users, the use of disposable devices increased from 3% to 15.2% for middle schoolers and from 2.4% to 26.5% for high schoolers.
  • A group of 47 UK charities warned that without government action, the COVID-19 pandemic could cause the UK’s cancer death rate to increase for the first time in decades. The warning highlights delays in cancer screening, diagnosis, and treatment during the pandemic, as well as disruptions to clinical trials. It urges governments to take steps such as directing resources into clearing the backlog of cancer cases, encouraging people with signs of cancer to seek care, and expanding the cancer workforce.
  • Five research teams were awarded Cancer Research UK–Children with Cancer UK Innovation Awards. Each team will receive up to $1.4 million over the next 3 years. With the funding, researchers will tackle projects such as analyzing inherited risk for solid cancers, developing targeted immunotherapy for leukemia in infants, and creating an atlas of rhabdomyosarcoma cases.

March 5–11

  • The FDA approved tivozanib (Fotivda; AVEO Oncology) for patients with relapsed/refractory advanced renal cell carcinoma who have received at least two prior therapies. The approval was based on the phase III TIVO-3 trial, in which patients treated with the agent had a median progression-free survival of 5.6 months and a median overall survival (OS) of 16.4 months, compared with 3.9 months and 19.2 months for patients who received sorafenib. The approval is the first for tivozanib, a VEGF tyrosine kinase inhibitor.
  • The agency also approved axicabtagene ciloleucel (Yescarta; Kite Pharma) in patients with relapsed/refractory follicular lymphoma who have received at least two prior therapies. The approval is based on the phase II ZUMA-5 trial, in which 91% of patients responded to the drug and 74% of patients were in remission at 18 months. A chimeric antigen receptor T-cell therapy, axicabtagene ciloleucel was previously approved for certain types of large B-cell lymphoma.
  • Following a review of recent research, the U.S. Preventive Services Task Force released a final guideline that expands the criteria for lung cancer screening (JAMA 2021;325;962–70). The document calls for screening adults ages 50 to 80 who have a 20 pack-year smoking history and who currently smoke or have quit within the past 15 years. Previously, the agency recommended that screening start at age 55 for people with a 30 pack-year smoking history.
  • Roche will stop marketing the PD-L1 inhibitor atezolizumab (Tecentriq) in the United States for patients with metastatic urothelial carcinoma who have received platinum-based chemotherapy. The decision was made in consultation with the FDA after the agent failed to meet its OS endpoint in the phase III IMvigor211 trial. The FDA had granted atezolizumab accelerated approval in 2016 based on results of the phase II IMvigor210 trial. In late April, the FDA Oncologic Drugs Advisory Committee will convene a meeting to review six other accelerated approvals for PD-1/PD-L1 agents.
  • The Bruton tyrosine kinase (BTK) inhibitor pirtobrutinib (LOXO-305; Loxo Oncology) may be effective in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), mantle cell lymphoma, and other non-Hodgkin lymphomas (Lancet 2021;397:892–901). In the phase I/II BRUIN trial, the agent elicited overall response rates (ORR) ranging from 52% to 71%, depending on the disease; 121 patients with CLL or SLL previously treated with a BTK inhibitor had an ORR of 67%.
  • A study suggests that the globalization of cancer clinical trials may contribute to racial disparities in enrollment (Cancer 2021 Mar 8 [Epub ahead of print]). Researchers analyzed 49 international trials that led to 35 drug approvals by the FDA between 2015 and 2018. They found that, overall, Black patients accounted for only 2.5% of enrollment, and trials with more patients enrolled outside the United States had fewer Black participants.
  • Based on findings from the phase III CANOPY-2 trial, Novartis announced that adding the IL1β inhibitor canakinumab (ACZ885) to chemotherapy may not improve OS of patients with locally advanced or metastatic non–small cell lung cancer who have received treatment. Canakinumab will continue to be tested as a first-line and adjuvant therapy in the phase III CANOPY-1 and CANOPY-A trials.

February 26–March 4

  • Amgen announced it will acquire Five Prime Therapeutics for $1.9 billion. In the deal, Amgen will gain Five Prime’s anti-FGFR2b agent bemarituzumab (FPA144), which is in clinical testing for patients with advanced gastric cancer and FGFR2b mutations. In the phase II FIGHT trial, bemarituzumab plus chemotherapy led to longer overall and progression-free survival than chemotherapy alone.
  • The FDA approved the ALK inhibitor lorlatinib (Lorbrena; Pfizer) in patients newly diagnosed with metastatic non–small cell lung cancer (NSCLC) who have ALK mutations. The approval was based on the phase III CROWN trial, in which the agent reduced the risk of disease progression or death by 72% compared with crizotinib (Xalkori; Pfizer). The agency also converted lorlatinib’s 2018 accelerated approval for previously treated ALK-positive NSCLC into a full approval.
  • The FDA also granted accelerated approval to melphalan flufenamide (Pepaxto; Oncopeptides AB) plus dexamethasone in patients with relapsed/refractory multiple myeloma who have received at least four prior therapies. The decision was based on the phase II HORIZON trial, in which the drug elicited an overall response rate of 23.7%, and patients responded for a median of 4.2 months. The approval is the first for melphalan flufenamide, a peptide–drug conjugate.
  • Researchers reported that blinatumomab may be effective in children with high-risk relapsed B-cell acute lymphoblastic leukemia (JAMA 2020;325:843–54). In a phase III trial, 31% of patients treated with blinatumomab experienced relapse, death, or a second malignancy after a median of 22.4 months, compared with 57% of those who received consolidation chemotherapy. Blinatumomab is a bispecific antibody that targets CD3 and CD19.
  • An analysis revealed that the COVID-19 pandemic may be disrupting pediatric cancer care worldwide (Lancet Child Adolesc Health 2021 Mar 3 [Epub ahead of print]). Researchers surveyed pediatric oncology providers at 213 institutions in 79 countries between June 22 and August 21, 2020. Overall, 43% of centers reported a decrease in newly diagnosed pediatric cancers and 34% reported an increase in "treatment abandonment," defined as a failure to start treatment or a delay in care of 4 weeks or longer.
  • Merck announced it will stop U.S. marketing of pembrolizumab (Keytruda) for previously treated metastatic small cell lung cancer. The decision came after the agent failed to improve overall survival in the phase III KEYNOTE-604 trial. Previously, the FDA granted the PD-L1 inhibitor accelerated approval for this indication based on encouraging results in the early-phase KEYNOTE-158 and KEYNOTE-028 trials.

February 2020

February 19–25

  • The FDA approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo; Regeneron/Sanofi) as a first-line treatment for patients with advanced non–small cell lung cancer and high PD-L1 expression. The approval was based on the phase III EMPOWER-Lung 1 trial, in which patients treated with the agent had a median overall survival (OS) of 22.1 months and a median progression-free survival (PFS) of 6.2 months, compared with 14.3 months and 5.6 months, respectively, in patients who received chemotherapy.
  • Idecabtagene vicleucel (ide-cel/bb2121; Bluebird Bio/Celgene) may be effective in patients with relapsed/refractory multiple myeloma (N Engl J Med 2021 Feb 25 [Epub ahead of print]). In the phase II KarMMa trial, 128 patients had an overall response rate of 73% and a median PFS of 8.8 months. Idecabtagene vicleucel is an autologous chimeric antigen receptor T-cell therapy that targets B-cell maturation antigen.
  • The launch of a new foundation called Break Through Cancer was announced. The foundation will bring together cancer scientists at five institutions: The Koch Institute for Integrative Cancer Research at MIT in Cambridge, MA, the Dana-Farber Cancer Institute in Boston, MA, Memorial Sloan Kettering Cancer Center in New York, NY, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, MD, and The University of Texas MD Anderson Cancer Center in Houston. Multidisciplinary teams will conduct translational research on difficult-to-treat malignancies such as pancreatic cancer, ovarian cancer, glioblastoma, and acute myeloid leukemia.
  • AstraZeneca will stop marketing the PD-L1 inhibitor durvalumab (Imfinzi) for locally advanced or metastatic bladder cancer in the United States. The FDA previously granted the agent an accelerated approval based on encouraging results in the phase I/II Study 1108 trial. The agent has since failed to meet its primary endpoint of improving OS compared with standard chemotherapy in the phase III DANUBE trial, prompting the decision.
  • The Epidemiology of Young Lung Cancer study launched to investigate the underlying causes of lung cancer in patients diagnosed before age 40. Researchers aim to gather medical, environmental, demographic, and lifestyle data from 250 patients with early-onset lung cancer and use this information to identify potential risk factors. The effort is a collaboration between the Addario Lung Cancer Medical Institute and the GO2 Foundation for Lung Cancer.
  • "Once we beat COVID, we’re going to do everything we can to end cancer as we know it," President Joe Biden said during a speech he gave after a tour of one of Pfizer’s COVID-19 vaccine manufacturing sites. Biden added that the President’s Council of Advisors on Science and Technology and the Office of Science and Technology Policy are developing an “advanced research effort on cancer and other diseases.” While serving as vice president, Biden led the White House’s Cancer Moonshot initiative.

February 12–18

  • Lenvatinib (Lenvima; Eisai) plus pembrolizumab (Keytruda; Merck) or everolimus (Afinitor; Novartis) may be effective in patients with advanced renal cell carcinoma. In the phase III CLEAR trial, patients treated with the pembrolizumab combination had a median progression-free survival (PFS) of 23.9 months and an objective response rate of 71%, compared with 14.7 months and 53.5% in patients who received the everolimus combination, and 9.2 months and 36.1%, respectively, in those who received standard sunitinib (Sutent; Pfizer). Findings were presented at the 2021 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, held virtually February 11–13, and simultaneously published (N Engl J Med 2021 Feb 13 [Epub ahead of print]).
  • Also presented at ASCO GU and published concurrently, researchers reported that the Nectin4-directed antibody–drug conjugate enfortumab vedotin (Seattle Genetics/Astellas) may extend survival for patients with advanced urothelial carcinoma who have already received chemotherapy and a PD-1–PD-L1 inhibitor (N Engl J Med 2021 Feb 12 [Epub ahead of print]). In the phase III EV-301 trial, patients treated with the agent had a median overall survival (OS) of about 12.9 months and a median PFS of 5.6 months, compared with nearly 9 months and 3.7 months, respectively, in patients who received standard chemotherapy. /li>
  • The tyrosine kinase inhibitor cabozantinib (Cabometyx; Exelixis) may be superior to sunitinib in patients with metastatic papillary renal cell carcinoma, according to findings reported at ASCO GU and concurrently published (Lancet 2021;397:P695–703). In a phase II trial, cabozantinib led to a response rate of 23% and a median PFS of 9 months, compared with 4% and 5.6 months for sunitinib.
  • Regeneron/Sanofi’s PD-1 inhibitor cemiplimab-rwlc may improve survival for patients newly diagnosed with advanced non–small cell lung cancer and high PD-L1 expression (Lancet 2021;397:P592¬–604). In the phase III EMPOWER-Lung 1 trial, patients treated with the agent did not reach median OS and had a median PFS of 8.2 months, compared with 14.2 months and 5.7 months, respectively, in patients who received standard chemotherapy.
  • The FDA approved the CDK4/6 inhibitor trilaciclib (Cosela; G1 Therapeutics) to protect bone marrow function and reduce the risk of severe neutropenia in patients receiving chemotherapy for extensive-stage small cell lung cancer. The approval was based on pooled findings from three randomized trials in which 11.4% of patients treated with the agent developed severe neutropenia during chemotherapy, compared with 52.9% of patients who received a placebo.
  • U.S. cancer centers and organizations issued a letter urging the Biden administration to prioritize COVID-19 vaccines for patients with cancer and survivors of cancer. "There is mounting evidence that patients with cancer are at increased risk of severe illness and death if they are infected with the virus," the letter states, adding that certain cancer survivors also have a higher risk of infection and death. The document was signed by more than 130 organizations, including the American Association for Cancer Research and the European Society for Medical Oncology.
  • The Leukemia & Lymphoma Society (LLS) launched the LLS National Patient Registry to gather data on patients with blood cancer who have been vaccinated against COVID-19, as well as those who have tested positive for the virus. Researchers aim to understand how patients with hematologic malignancies respond to the vaccine based on their type of cancer and any treatment they are receiving. Patients can join at www.lls.org.

February 5–11

  • Adjuvant nivolumab may be effective in patients with muscle-invasive urothelial carcinoma, according to findings presented at the 2021 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, held virtually February 11–13. In the phase III CheckMate 274 trial, patients treated with the PD-1 inhibitor after surgery had a median disease-free survival of 21 months, compared with 10.9 months in patients who received a placebo.
  • Also at ASCO GU, researchers reported that a decrease in prostate-specific antigen (PSA) testing has led to an increase in metastatic disease at diagnosis. Investigators analyzed data on PSA screening and metastatic prostate cancer in each U.S. state between 2008 and 2016. They found that the average percentage of eligible men screened for PSA overall decreased from 61.8% to 50.5%, while the incidence of metastatic disease at diagnosis increased from 6.4 to 9 cases per 100,000 men—and bigger drops in PSA screening were associated with larger increases in metastatic prostate cancer diagnoses.
  • The FDA approved lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) in adults with relapsed/refractory large B-cell lymphoma who previously received at least two other therapies. The approval was based on the TRANSCEND NHL 001 trial, in which 192 patients had an overall response rate of 73% and a complete response rate of 54%. The approval is the first for lisocabtagene maraleucel, a chimeric antigen receptor T-cell therapy that targets CD19.
  • The FDA approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo; Regeneron/Sanofi) in patients with locally advanced basal cell carcinoma who have already received a hedgehog pathway inhibitor (HHI), or who aren’t eligible for an HHI. The agency also granted accelerated approval to the drug for use in patients with metastatic disease. The approvals were based on Study 1620, in which patients with advanced disease had an objective response rate of 29%, and those with metastatic disease had an objective response rate of 21%.
  • The agency also granted accelerated approval to the PI3Kδ inhibitor umbralisib (Ukoniq; TG Therapeutics) in patients with relapsed/refractory marginal zone lymphoma (MZL) who received at least one prior anti-CD20 therapy, as well as in patients with relapsed/refractory follicular lymphoma (FL) who received at least three prior therapies. In the phase II UNITY-NHL trial, the agent elicited responses in 49% and 43% of patients with MZL and FL, respectively.
  • The FDA Oncologic Drugs Advisory Committee voted 10 to 0 against pembrolizumab (Keytruda; Merck) as a neoadjuvant therapy for high-risk triple-negative breast cancer. The committee concluded that the 7.5% improvement in pathologic complete response seen in the phase III KEYNOTE-522 trial is not large enough to indicate a clinical benefit, and more definitive findings are needed. The trial will continue to amass data on event-free survival and overall survival (OS).
  • AstraZeneca announced that durvalumab (Imfinzi) may not extend survival in patients with recurrent or metastatic head and neck squamous cell carcinoma and high PD-L1 expression. In the phase III KESTREL trial, the agent did not improve OS compared with standard chemotherapy. A PD-L1 inhibitor, durvalumab is FDA approved for certain forms of lung and bladder cancer.

January 29–February 4

  • At the American Association for Cancer Research (AACR) Virtual Meeting: COVID-19 and Cancer, held February 3–5, researchers reported that patients with lymphoma treated with B cell–depleting therapies may have poor outcomes if they develop severe COVID-19. Researchers evaluated 111 patients with lymphoma admitted to the hospital with severe COVID-19 infections, 63 of whom had received B cell–depleting therapies within the past year. These patients were almost twice as likely to stay in the hospital for more than 30 days than those who had received other therapies—and they were more than twice as likely to die.
  • Also at the AACR COVID-19 and Cancer meeting, researchers highlighted the financial burden of the COVID-19 pandemic on people who survive cancer. The team analyzed data from 10,760 U.S. adults during the pandemic, including 854 people who had been diagnosed with cancer. They found that 18% of cancer survivors experienced financial hardship during the pandemic; younger adults and those insured through Medicaid or living in rural areas were more likely to experience money troubles than those who had not been diagnosed with cancer.
  • A pair of papers revealed that fecal microbiota transplant (FMT) may improve immunotherapy responses in patients with melanoma. In one study, researchers transplanted fecal microbiota from seven immunotherapy responders to 16 patients with PD-1–refractory melanoma (Science 2021;6529:595–602). After transplant, six of the recipients responded to pembrolizumab (Keytruda; Merck). The second paper reported on a phase I trial in which three of 10 patients who had progressed on immunotherapy responded to a PD-1 inhibitor after FMT (Science 2021;6529:602–9).
  • People who survive cancer are more likely to have underlying medical conditions linked to severe COVID-19 than those in the general population (J Natl Cancer Inst 2021 Feb 3 [Epub ahead of print]). Researchers analyzed data from 6,411 people who had had cancer and 77,748 people without a history of cancer. They found that 56.4% of survivors had at least one medical condition associated with an increased risk of severe COVID-19, such as heart disease and diabetes, compared with 41.6% of people who hadn’t had cancer.
  • The FDA granted accelerated approval to tepotinib (Tepmetko; EMD Serono) in patients with metastatic non–small cell lung cancer with MET exon 14 skipping mutations. The approval was based on the phase II VISION trial, in which 69 newly diagnosed patients had an overall response rate (ORR) of 43% and a median duration of response (DoR) of 10.8 months; 83 patients who had received prior therapies had an ORR of 43% and a median DoR of 11.1 months.
  • The World Health Organization announced that breast cancer is now the most common form of cancer worldwide. In 2020, 2.3 million new cases of breast cancer were diagnosed, accounting for 11.7% of all cancer cases. Lung cancer—which had been the most common malignancy for the past two decades—is now second, followed by colorectal cancer.

January 2021

January 22–28

  • The KRASG12C inhibitor sotorasib (Amgen) may be effective in patients with previously treated non–small cell lung cancer (NSCLC), according to results presented at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer (WCLC), rescheduled from August and being held virtually January 28–31. In the phase II CodeBreak 100 trial, 124 patients had an objective response rate (ORR) of 37.1% and a median progression-free survival (PFS) of 6.8 months; responses lasted for a median of 10 months. Based on these data, Amgen filed for FDA approval of the drug in December 2020.
  • Also at the WCLC, researchers reported that amivantamab (Janssen) may be an effective therapy for patients with metastatic or inoperable NSCLC and EGFR exon 20 insertions who have already received chemotherapy. In the phase I CHRYSALIS trial, 40% of 81 patients responded; they had a median PFS of 8.3 months and a median overall survival (OS) of 22.8 months. Amivantamab is a bispecific antibody that targets EGFR and MET.
  • Datopotamab deruxtecan (AstraZeneca/Daiichi Sankyo) may be active in patients with advanced or metastatic NSCLC, researchers reported at the WCLC. In the phase I TROPION-PanTumor01 trial, 159 patients had ORRs ranging from 21% to 25%, depending on the dose; disease control rates ranged from 67% to 80%, and median PFS was 4.3 to 8.2 months. Datopotamab deruxtecan is an antibody–drug conjugate that consists of a TROP2-directed monoclonal antibody linked to a topoisomerase 1 inhibitor derived from exatecan.
  • Bristol Myers Squibb announced that the FDA approved nivolumab (Opdivo) plus cabozantinib (Cabometyx; Exelixis) for advanced renal cell carcinoma. The approval was based on the phase III CHECKMATE-9ER trial, in which newly diagnosed patients treated with the combination had a median PFS of 16.6 months and an overall response rate of 55.7%, compared with 8.3 months and 27.1%, respectively, in patients who received nivolumab, a PD-1 inhibitor, plus sunitinib (Sutent; Pfizer).
  • The American Lung Association released its 19th annual State of Tobacco Control report. The publication calls for ending sales of flavored tobacco products to reduce their use among kids as well as in Black communities. The report also highlights the increased need to prioritize smoking cessation during the COVID-19 pandemic, noting that smoking raises the risk of severe infection.
  • The National Comprehensive Cancer Network (NCCN) published guidelines on administering COVID-19 vaccines to patients with cancer. The document recommends vaccinating all patients undergoing active cancer treatment as soon as possible. It also offers suggestions for prioritizing patients for vaccines, scheduling inoculations around immunosuppressive therapy, and handling drug interactions or side effects, among other things.
  • U.S. cancer centers and organizations issued a public letter urging the resumption of cancer screening and treatment during the COVID-19 pandemic. The letter, which was written by the NCCN and the American Cancer Society, and signed by 76 other organizations, highlights considerable drops in cancer screening and diagnosis—as well as delays in treatment—during the pandemic.
  • President Joe Biden nominated Eric Lander, PhD, to serve as his science advisor and director of the Office of Science and Technology Policy, and Rochelle Walensky, MD, MPH, to lead the Centers for Disease Control and Prevention. Biden also appointed Janet Woodcock, MD, as acting commissioner of the FDA. Lander heads the Broad Institute of MIT and Harvard in Cambridge, MA, and Walensky is chief of the Infectious Diseases Division at Massachusetts General Hospital in Boston; Woodcock served as director of the FDA’s Center for Drug Evaluation and Research.

January 15–21

  • During the American Society of Clinical Oncology (ASCO) 2021 Gastrointestinal (GI) Cancers Symposium, held virtually January 15–17, researchers reported that adding bemarituzumab (FPA144; Five Prime) to chemotherapy may improve survival for patients with advanced gastric cancer and FGFR2b mutations. In the phase II FIGHT trial, patients treated with the combination had a median progression-free survival (PFS) of 9.5 months and did not reach median overall survival (OS), compared with 7.4 months and 12.9 months, respectively, in patients who received chemotherapy alone. Bemarituzumab is a targeted antibody that inhibits FBFR2b.
  • The investigational CD73 inhibitor AB680 (Arcus Biosciences) combined with nab-paclitaxel (Abraxane; Celgene) plus gemcitabine and zimberelimab (AB122; Arcus) may be effective in patients newly diagnosed with metastatic pancreatic cancer, researchers reported at the ASCO GI meeting. In a phase I trial, seven of 17 patients responded to the combination, and eight others experienced some tumor shrinkage.
  • The FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who previously received trastuzumab (Herceptin; Genentech). The approval was based on the phase II DESTINY-Gastric01 trial, in which patients treated with the agent had a median OS of 12.5 months, compared with 8.4 months in patients who received chemotherapy. Fam-trastuzumab deruxtecan-nxki consists of the anti-HER2 monoclonal antibody trastuzumab connected to deruxtecan, a topoisomerase I inhibitor.
  • The Community Oncology Alliance requested that community oncologists be given priority approval to administer COVID-19 vaccinations to their patients with cancer and blood disorders who are immunocompromised. The request, which was made to state governors and the U.S. government, also asked that oncologists be provided with enough vaccines to complete the inoculations.
  • Black women in the United States may be at greater risk of breast cancer recurrence than white women, according to findings in JAMA Oncology. Researchers analyzed Oncotype DX Breast Recurrence Score tests from 86,033 women with breast cancer. They found that Black women were significantly more likely than white women to have a recurrence score greater than 25; moreover, Black women were more likely to die from breast cancer than white women with comparable recurrence risk. They also discovered that the prognostic accuracy of the recurrence score was significantly lower in Black women than white women, highlighting the need to calibrate such tests in more diverse populations.
  • GlaxoSmithKline reported that bintrafusp alfa (M7824) may not be effective at treating non–small cell lung cancer that expresses PD-L1. In the phase III INTR@PID Lung 037 trial, the drug did not improve PFS compared with the PD-1 inhibitor pembrolizumab (Keytruda; Merck), leading an independent data monitoring committee to recommend discontinuing the trial. A bifunctional immunotherapy that blocks TGFβ and PD-L1, bintrafusp alfa will continue testing in other trials.

January 8–14

  • Sanofi announced it will acquire Kymab for $1.1 billion up front and up to $350 million more in milestone payments. Sanofi will gain KY1044, an anti-ICOS antibody that is being tested alone and in combination with a PD-L1 inhibitor in solid cancers. Sanofi’s purchase also includes Kymab’s leading candidate KY1005, an anti-OX40L antibody being assessed for various immune disorders.
  • Novartis will pay BeiGene $650 million up front and as much as $1.55 billion in milestone payments for the PD-1 inhibitor tislelizumab. Novartis will acquire rights to develop, manufacture, and commercialize the drug in North America, Japan, the European Union, and six other European countries. Tislelizumab is approved in China for certain forms of classic Hodgkin lymphoma, urothelial carcinoma, and non–small cell lung cancer (NSCLC).
  • The American Cancer Society (ACS) reported that the cancer mortality rate decreased by 2.4% from 2017 to 2018 in the United States, the biggest single-year drop on record. The ACS estimated that there will be 1.9 million new cancer diagnoses and 600,000 cancer-related deaths in 2021. However, the projections don’t account for the COVID-19 pandemic, which has disrupted cancer screenings and care.
  • In The New England Journal of Medicine, a report revealed the distribution of KRASG12C mutations by race and sex. Researchers analyzed the prevalence of KRASG12C mutations in 32,138 patients with cancer, 13.8% of whom had NSCLC. They found that among patients with NSCLC, KRASG12C mutations occurred in 13% of white, 10.9% of Black, and 3.6% of Asian patients. This mutation was significantly more common in white and Asian women with NSCLC than their male counterparts.
  • The FDA approved crizotinib (Xalkori; Pfizer) in children and young adults with relapsed/refractory, systemic anaplastic large cell lymphoma who have ALK mutations. The approval was based on a phase I/II trial in which 26 patients had an objective response rate of 88% and a complete remission rate of 81%. An ALK inhibitor, crizotinib was previously approved for patients with NSCLC who have ALK or ROS1 mutations.
  • The FDA placed a clinical hold on Neoleukin Therapeutics’ phase I trial of NL-201. The agency asked Neoleukin to develop a new assay that more precisely measures dosing of the drug. NL-201 is a protein therapeutic that stimulates IL2 and IL15 signaling.
  • U.S. Customs and Border Protection and the FDA announced the seizure of counterfeit, unauthorized electronic cigarette (e-cigarette) cartridges. In January, a shipment of 33,681 cartridges was discovered at the Dallas Fort Worth International Airport in Texas. In December, the agencies seized 42 shipments of e-cigarette cartridges from China en route to several Texas counties. In both instances, the shipments included flavored cartridges that are illegal in the United States.

December 29–January 7

  • In The New England Journal of Medicine, a paper documented two instances of vaginal cancer transmission from mother to infant. Next-generation sequencing revealed that a 2-year-old and a 6-year-old boy with lung cancer developed the malignancies from uterine cervical tumors that were transferred from their mothers during childbirth. In each case, the child’s tumor lacked a Y chromosome, and shared somatic mutations, a human papillomavirus genome, and single-nucleotide polymorphism alleles with the mother’s tumor.
  • After consulting with the FDA, Bristol Myers Squibb withdrew nivolumab (Opdivo) from the U.S. market for patients with small cell lung cancer who had received prior therapies. The decision was based on the phase III CheckMate-451 and CheckMate-331 trials, in which the PD-1 inhibitor did not improve overall survival (OS) compared with standard therapies. The FDA had granted nivolumab an accelerated approval in August 2018 based on promising results in the phase I/II CheckMate-032 trial.
  • Adding bevacizumab (Avastin; Genentech) to osimertinib (Tagrisso; AstraZeneca) may not improve the latter’s efficacy in patients with EGFR-mutant non–small cell lung cancer (NSCLC), researchers reported in JAMA Oncology. In a phase II trial, the combination did not increase progression-free survival (PFS) or OS compared with osimertinib alone. Researchers had hypothesized that bevacizumab, an angiogenesis inhibitor, might amplify the effects of osimertinib, a tyrosine kinase inhibitor.
  • Calithera announced that its glutaminase inhibitor telaglenastat plus cabozantinib (Cabometyx; Exelixis) may not be effective in advanced or metastatic renal cell carcinoma. In the phase II CANTATA trial, the combination did not improve PFS compared with cabozantinib alone. Given the negative results, the company will cut its workforce by approximately 35%, although testing will continue in NSCLC.
  • Eprenetapopt (APR-246; Aprea Therapeutics) plus azacitidine failed to improve outcomes in patients with TP53-mutant myelodysplastic syndromes. In a phase III trial, the combination did not significantly increase the complete remission rate compared with azacitidine alone, although the company will continue to analyze the data as it matures. Eprenetapopt is a small molecule that reactivates mutant TP53.
  • Men of African ancestry may be at higher risk of developing prostate cancer than those of European ancestry, according to findings in Nature Genetics. Researchers conducted a meta-analysis of prostate cancer studies that included 107,247 patients and 127,006 control subjects. They identified 86 new genetic risk variants associated with the disease and determined that men of African descent had a risk score that was 2.18 times higher on average than that of men with European backgrounds.

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