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.
|Printer friendly Cite/link Email Feedback|
|Date:||Dec 5, 2018|
|Previous Article:||Genentech granted priority review for Tencentriq, chemotherapy combination.|
|Next Article:||U.S. Silica announces price increases on industrial and specialty products.|