Exelixis Announces Positive Overall Survival Results From CoBRIM - Quick Facts

(RTTNews) - Exelixis Inc. (EXEL) announced positive overall survival or OS results from coBRIM, the phase 3 pivotal trial evaluating cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma carrying a BRAF V600 mutation.

Exelixis' collaborator Genentech, a member of the Roche Group, informed the company 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.

Exelixis announced the first regulatory approval of cobimetinib in Switzerland in August 2015. U.S. and EU regulatory applications sponsored by Genentech and Roche, respectively, are currently under review. In the United States, the Prescription Drug User Fee Act action date is November 11, 2015. In the EU, Roche anticipates a regulatory decision by the end of this year following a positive opinion from the European Committee for Medicinal Products for Human Use announced in late September.