Exelixis, Ipsen planning cabozantinib submissions in HCC
Exelixis Inc. (NASDAQ:EXEL) and partner Ipsen Group (Euronext:IPN; Pink:IPSEY) plan to submit regulatory applications in 2018 for cabozantinib (XL184) as a second-line treatment of advanced hepatocellular carcinoma (HCC) after the drug met the primary endpoint of improving median overall survival (OS) vs. placebo in the Phase III CELESTIAL trial. Based on a planned second interim analysis, an IDMC recommended the trial be stopped for efficacy. The double-blind, international trial was designed to enroll 760 patients with advanced HCC who were previously treated with Nexavar sorafenib to receive once-daily oral 60 mg cabozantinib or placebo. Secondary endpoints include progression-free-survival (PFS) and objective response rate (ORR).
Exelixis plans to submit an sNDA to FDA next quarter, while Ipsen expects to submit the candidate to EMA in 1H18. Ipsen has rights to cabozantinib outside the U.S. and Japan from Exelixis (see BioCentury, March 7, 2016)...