Genentech has announced that its phase 3 coBRIM study, evaluating the safety and efficacy of a combination of cobimetinib and vemurafenib for the treatment of melanoma, has met its primary endpoint.
Genentech, a Roche company, studied the combination in 495patients with BRAF V600 advanced or metastatic melanoma. According to Genentech, cobimetinib is designed to block the activity of MEK, one of a series of cellular proteins that make up a signaling pathway that helps regulate cell division and survival. Cobimetinib binds to MEK while vemurafenib (Zelboraf, Genentech) binds to mutant BRAF, another protein on the pathway, to interrupt abnormal signaling that can cause tumors to grow.
“The study demonstrated, in a randomized fashion, that the investigational MEK inhibitor cobimetinib, used in combination with Roche’s BRAF inhibitor Zelboraf, helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer without their disease worsening, compared to Zelboraf alone,” Omid Hamid, M.D., coBRIM investigator and chief of research/immuno-oncology at the Angeles Clinic & Research Institute in Los Angeles, tells Dermatology Times. “Advances in the combination of targeted agents in melanoma hold the promise of improved survival. This combination, with initial data recently presented in Lancet Oncology, will be the backbone of future trials in combination with promising immunotherapies in melanoma. It represents the pinnacle of personalized medicine for melanoma, targeting known mutations for optimal benefit.”
Dr. Hamid says adverse events were consistent with those observed in a previous study of the combination, adding that full results will be presented at an upcoming meeting.
Genentech officials say they plan to submit the data to the Food and Drug Administration for potential approval.