Exelixis Inc. said the phase 3 trial of Cabometyx met its main goal of overall survival in patients with advanced hepatocellular carcinoma, a form of liver cancer.
The CELESTIAL study, conducted in 760 patients, showed the drug is better than placebo in improving overall survival, or OS, a measure of how long a patient lives after diagnosis or start of treatment.
The study recorded a 32% increase in the median OS of patients treated with the drug versus the assumed median OS of 8.2 months for placebo.
The study's independent monitoring committee previously recommended stopping the trial for efficacy. However, the company said it will discuss the trial results with regulatory authorities and determine next steps.
The company is also planning a supplemental new drug application for Cabometyx, or cabozantinib, with the U.S. Food and Drug Administration in the first quarter of 2018.
Cabometyx is already approved in the U.S. for advanced liver cancer patients who have received prior anti-angiogenic therapy.