Noted This Week
Lilly Oncology announced that ramucirumab (Cyramza) plus erlotinib (Tarceva; Genentech) may improve outcomes in patients with newly diagnosed, EGFR-mutant non–small cell lung cancer. In the phase III RELAY trial, patients treated with the EGFR inhibitor/VEGFR2 inhibitor combination had a median progression-free survival of 19.4 months, compared with 12.4 months in patients who received a placebo plus erlotinib. Results were published in The Lancet Oncology.
GRAIL released data validating its multicancer early-detection test that analyzes cell-free DNA in blood samples. The company ran its test on 1,264 participants from the Circulating Cell-Free Genome Atlas and STRIVE studies, including 654 people with cancer. With 99.3% specificity, the test had an overall detection rate of 76% for 12 cancers that generally have poor outcomes, including detection rates of 39% and 69% for stage I and stage II disease, respectively.
Bristol-Myers Squibb’s nivolumab (Opdivo) plus bevacizumab (Avastin; Genentech) may be a promising therapy in patients with relapsed epithelial ovarian cancer, according to findings in JAMA Oncology. In a phase II trial of 38 women, 28.9% had an objective response to the drug, including 40% with platinum-sensitive disease and 16.7% with platinum-resistant disease. A PD-1 inhibitor, nivolumab is approved for a variety of cancers, including melanoma, lung cancer, and hepatocellular carcinoma.
At the Biopharma Congress in Washington, DC, FDA leaders expressed concern about the agency's ability to recruit and retain experts in cutting-edge scientific fields such as cell and gene therapies and oncology. “We’re dealing with the issue of a very competitive job market,” said Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Review. The FDA is considering measures such as increasing salary caps and transitioning to a more academic model in which its medical oncologists are encouraged to develop expertise on a particular topic and take on responsibilities beyond day-to-day review work.
The FDA awarded more than $15 million in grants to 12 research groups developing therapies for rare diseases. Eight of the grants will fund clinical trials in rare cancers, including high-grade gliomas, squamous cell carcinoma, and pediatric malignant cerebellar brain tumors. The grants, awarded through the FDA’s Orphan Products Clinical Trials Grants Program, will be spread over 3 to 4 years.