Exelixis and Ipsen Initiate Phase 3 Pivotal Trial for Advanced Hepatocellular Carcinoma Treatment

Evelix’s, Inc. and Ipsen have announced the initiation of COSMIC-312, a phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) versus sorafenib in previously untreated advanced hepatocellular carcinoma (HCC). The 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.

"Liver cancer is the fastest-rising cause of cancer-related death in the U.S., underscoring the need for new treatment options for this patient community," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "Based on past evidence of potential synergistic effects with cabozantinib and immune checkpoint inhibitors, the combination offers promise for patients with advanced liver cancer who have not received prior treatment."

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 (40 mg) and atezolizumab, sorafenib, or cabozantinib (60 mg).

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.

"With more than 800,000 new diagnoses of liver cancer worldwide each year and a poor prognosis for patients with advanced disease, there is an urgent need to identify new treatment options," said R. Kate Kelley, M.D., Associate Professor of Clinical Medicine, Division of Hematology/Oncology, University of California, San Francisco, and lead investigator on COSMIC-312. "We look forward to learning whether the combination of cabozantinib and atezolizumab may improve outcomes for previously untreated patients."

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