Phase III trial of Stivarga (regorafenib) for hepatocellular carcinoma meets primary endpoint- Bayer HealthCare

Bayer HealthCare has announced that a Phase III trial evaluating its oncology compound Stivarga (regorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC) has met its primary endpoint of a statistically significant improvement in overall survival. The study, called RESORCE, evaluated the efficacy and safety of regorafenib in patients with HCC whose disease has progressed after treatment with sorafenib. The safety and tolerability were generally consistent with the known profile of regorafenib.

The RESORCE clinical trial is a randomized, double blind, placebo controlled, multicenter Phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) whose disease has progressed after treatment with sorafenib. The trial enrolled approximately 573 patients who were randomized in a 2:1 ratio to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Detailed efficacy and safety analyses from this study are expected to be presented at an upcoming scientific congress. Bayer plans to submit data from the RESORCE study as the basis for marketing authorization of regorafenib in the treatment of unresectable HCC in 2016.