Exelixis (EXEL +27%) is trading at a new all-time high after announcing that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC) -- the most common form of liver cancer.
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.
Based on these results, Exelixis plans to submit a supplemental New Drug Application (sNDA) to the FDA in the first quarter of 2018.
Exelixis also announced that the FDA determined the company's supplemental New Drug Application (sNDA) for CABOMETYX for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted Priority Review of the filing and assigned a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2018.
Exelxisi's market cap is just over $9 billion. The stock hit a new high today and is up ~110% year-to-date.