Exelixis Begins Phase 3 Trial Of Cabozantinib In Patients With Advanced HCC

(RTTNews) - Exelixis Inc. (EXEL) announced Tuesday that it has initiated CELESTIAL, a phase 3 pivotal trial comparing cabozantinib with placebo in patients with advanced hepatocellular carcinoma or HCC who have previously been treated with sorafenib. The primary endpoint for the trial is overall survival or OS.

CELESTIAL is a randomized, double blind, placebo controlled study of cabozantinib in patients with advanced HCC that is being conducted at up to 200 sites globally in up to 30 countries. The trial is expected to enroll 760 patients with advanced HCC who have received prior sorafenib. Patients will be randomized 2:1 to receive 60 mg of cabozantinib daily or placebo.

The primary endpoint for the trial is OS, and the secondary endpoints include objective response rate (ORR) and progression-free survival (PFS). Exploratory endpoints include patient-reported outcomes, biomarkers, and safety.

Based on available clinical trial data, the primary endpoint assumes a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90% power to detect a 32% increase in OS (HR = 0.76). Interim analyses are planned once 50% and 75% of events have been observed, respectively.