Ipsen : Phase 3 CELESTIAL Trial Of Cabozantinib Meets Primary Endpoint In HCC

(RTTNews) - Ipsen (IPSEY) and its partner Exelixis (EXEL) announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival, with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma or 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. CELESTIAL is a randomized, global phase 3 trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. The safety data in the study were consistent with the established profile of cabozantinib.

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.