Stivarga regorafenib: Additional Phase III data

Additional data from the double-blind, international Phase III RESORCE trial in about 573 patients with unresectable HCC whose disease progressed after treatment with Nexavar sorafenib showed that once-daily 160 mg oral Stivarga for the first 3 weeks of each 4-week cycle plus best supportive care (BSC) led to a median OS, the primary endpoint, of 10.6 months vs. 7.8 months for placebo plus BSC (HR=0.62, 95% CI: 0.5, 0.78, p<0.001). Stivarga plus BSC also met the secondary endpoints of improving median PFS (3.1 vs. 1.5 months, HR=0.46, 95% CI: 0.37, 0.56, p<0.001), median time to progression (3.2 vs. 1.5 months, HR=0.44, 95% CI: 0.36, 0.55, p<0.001), DCR (65.2% vs. 36.1%, p<0.001) and ORR (10.6% vs. 4.1%, p=0.005) vs. placebo plus BSC. Bayer previously reported that Stivarga plus BSC met the primary endpoint (see BioCentury, May 16). ...