Phase III study of Cotellic (cobimetinib) with Zelboraf (vemurafenib) meets secondary endpoint in metastatic melanoma- Exelixis/Genentech

Exelixis announced positive overall survival (OS) results from coBRIM, the phase III pivotal trial evaluating Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) in previously untreated patients with unresectable locally advanced or metastatic melanoma carrying a BRAF V600 mutation. Exelixis’ collaborator Genentech announced that coBRIM met its secondary endpoint of demonstrating a statistically significant and clinically meaningful increase in overall survival for patients receiving the combination of cobimetinib and vemurafenib, as compared to vemurafenib monotherapy. Ongoing study monitoring did not identify any new safety signals. Long-term safety data are expected later this year. These data will be the subject of a presentation at an upcoming medical meeting.

Comment: The cobimetinib/vemurafenib combination will be in direct competition with Mekinist/Tafinlar combination from Novartis of the MEK inhibitor trametinib and the BRAF inhibitor dabrafenib, respectively. This combination was already approved in the US and recently in the EU.