Genentech reports success in coBRIM trial with cobimetinib + Zelboraf combination for Metastatic Melanoma

Genentech has announced that the Phase III coBRIM study met its primary endpoint. The study demonstrated that the investigational MEK inhibitor cobimetinib, used in combination with Genentech's BRAF inhibitor Zelboraf (vemurafenib), helped patients with previously untreated BRAF V600 mutation-positive Advanced Melanoma live significantly longer without their disease worsening (progression-free survival; PFS) compared to Zelboraf alone. Adverse events were consistent with those observed in a previous study of the combination.

CoBRIM is an international, randomized, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of cobimetinib in combination with Zelboraf, compared to Zelboraf alone, in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or Metastatic Melanoma, previously untreated for advanced disease. The primary endpoint for coBRIM is PFS. Secondary endpoints include overall survival, objective response rate, duration of response and other safety, pharmacokinetic and quality of life measures.

The coBRIM study used the Roche cobas 4800 BRAF Mutation Test to determine eligibility of patients for the study. This test identifies people whose tumors carry the BRAF V600 mutation, and therefore, patients who are most appropriate to receive this combination of treatments.