Exelixis, Ipsen report Phase III data for cabozantinib in HCC

Exelixis Inc. (NASDAQ:EXEL) and partner Ipsen (Euronext:IPN; PINK:IPSEY) reported additional data from the double-blind, international Phase III CELESTIAL trial of cabozantinib to treat advanced hepatocellular carcinoma (HCC). In October, the partners reported that the trial met the primary endpoint of improving median overall survival (OS) vs. placebo and was stopped for efficacy after a planned second interim analysis (prespecified critical p≤0.021), but did not report data (see BioCentury, Oct. 19, 2017).

In 707 evaluable patients, once-daily 60 mg oral cabozantinib led to median OS of 10.2 months vs. 8 months for placebo (HR=0.76, 95% CI: 0.63, 0.93, p=0.0049). On secondary endpoints, cabozantinib significantly increased median progression-free survival (PFS) (5.2 vs. 1.9 months, HR=0.44, 95% CI: 0.36, 0.52, p<0.0001) and objective response rate (ORR) vs. placebo (4% vs. 0.4%, p=0.0086)...