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Thursday, May 10, 2018

Exelixis-Genentech phase 3 colorectal cancer trial misses primary endpoint

Exelixis (EXEL) announced that IMblaze370, the phase 3 pivotal trial of atezolizumab, an anti-PDL1 antibody discovered and developed by Genentech, a member of the Roche Group (RHHBY), and cobimetinib, an Exelixis-discovered MEK inhibitor, did not meet its primary endpoint. Genentech, Exelixis’ collaborator and sponsor of the IMblaze370 trial, informed the company that the combination of atezolizumab and cobimetinib did not deliver an improvement in overall survival, or OS, versus regorafenib. The IMblaze370 trial evaluated the combination in patients with difficult-to-treat, locally advanced or metastatic colorectal cancer whose disease had progressed or who were intolerant to at least two systemic chemotherapy regimens. The safety profile for the combination appeared consistent with the known safety profile of each individual medicine, and no new safety signals were identified with the combination. Genentech will further examine results from IMblaze370 and plans to present the data at an upcoming medical meeting.

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