Phase III CELESTIAL trial of Cabometyx (cabozantinib) meets primary endpoint in advanced hepatocellular carcinoma.- Ipsen + Exelixis.

Ipsen and Exelixis announced that its global phase III CELESTIAL trial met its primary endpoint of overall survival (OS), with Cabometyx (cabozantinib) providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC). The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. The safety data in the study were consistent with the established profile of cabozantinib.

CELESTIAL is a randomized, global phase III trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. In line with and in collaboration with partner Exelixis, Ipsen expects to file in the first half of 2018 a variation of the initial application to the EMA and other relevant regulatory agencies and to evaluate potential next steps in the development strategy for cabozantinib outside the United States and Japan as a treatment for advanced HCC in patients who have been previously treated. Detailed results from CELESTIAL will be submitted for presentation at a future medical conference.