Exelixis, Ipsen initiate Phase 3 COSMIC-312 trial

Exelixis (EXEL) and Ipsen (IPSEY) announced the initiation of COSMIC-312, a phase 3 pivotal trial of cabozantinib versus sorafenib in previously untreated advanced hepatocellular carcinomaThe co-primary endpoints of the trial are progression-free survival and overall survival. An exploratory arm will also evaluate cabozantinib monotherapy in this first-line setting. COSMIC-312 is a multicenter, randomized, controlled phase 3 pivotal trial that aims to enroll approximately 640 patients at up to 200 sites globally. Patients will be randomized 6:3:1 to one of three arms: cabozantinib and atezolizumab, sorafenib, or cabozantinib. Exelixis is sponsoring COSMIC-312, and Ipsen will co-fund the trial. Ipsen will have access to the results to support potential future regulatory submissions outside of the U.S. and Japan. Genentech, a member of the Roche Group, is providing atezolizumab for use in this trial.
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