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Cabozantinib extends OS in advanced hepatocellular carcinoma
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A phase 3 trial designed to compare cabozantinib with placebo for patients with advanced hepatocellular carcinoma met its primary endpoint of OS.
Cabozantinib (Cabometyx, Exelixis) is a small molecule inhibitor of the MET, AXL and VEGFR2 tyrosine kinases.
The randomized, double-blind, placebo-controlled CELESTIAL trial included 760 patients with advanced HCC who received prior sorafenib (Nexavar, Bayer) and received up to two prior systemic cancer therapies. All study participants had adequate liver function.
Researchers randomly assigned patients 2:1 to 60 mg cabozantinib once daily or placebo.
OS served as the primary endpoint. Secondary endpoints included objective response rate and PFS. Exploratory endpoints included patient-reported outcomes, safety and biomarkers.
Detailed results from the trial will be submitted for presentation at a medical meeting.
Company officials intend to discuss the CELESTIAL results with regulatory authorities to determine the trial’s next steps, including the possibility that patients assigned placebo can be offered the chance to cross over to cabozantinib.
“We are excited that these positive results from the phase 3 CELESTIAL trial bring us one step closer to the potential of offering previously treated patients with this aggressive form of advanced liver cancer a much-needed new treatment option,” Gisela Schwab, MD, president of product development and medical affairs and chief medical officer at Exelixis, said in a company-issued press release. “This is an important milestone for the cabozantinib development program. We are committed to studying cabozantinib in a range of tumor types as part of our mission to deliver medicines that improve treatment outcomes and give patients hope for the future.”