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.
