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Exelixis, Inc. (NASDAQ:EXEL) today announced that it has initiated CELESTIAL, a phase 3 pivotal trial comparing cabozantinib with placebo in patients with advanced hepatocellular carcinoma (HCC) who have previously been treated with sorafenib. The primary endpoint for the trial is overall survival (OS).
“Patients with advanced HCC who have progressed on sorafenib have few therapeutic options, and new approaches to managing their disease are much needed,” said Ghassan K. Abou-Alfa, M.D., Associate Attending at Memorial Sloan-Kettering Cancer Center, New York and the lead investigator on CELESTIAL. “Phase 2 data investigating cabozantinib in this patient population are worthy of more study, and cabozantinib’s target profile, which includes inhibition of both MET and VEGFR, is highly relevant in HCC.”
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.
“The initiation of the CELESTIAL trial is an important milestone as we work to expand the cabozantinib franchise into additional indications with substantial unmet medical needs,” said Gisela Schwab, M.D., executive vice president and chief medical officer of Exelixis. “CELESTIAL is the fifth pivotal trial for cabozantinib overall, and the second phase 3 trial to initiate this year. It was designed with the input of leading oncologists and HCC experts, and we believe that the data will provide important insight into the role that cabozantinib may play in improving the care of patients with this disease.”