Bayer announced that a Phase 3 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. Detailed efficacy and safety analyses from this study are expected to be presented at an upcoming scientific congress.
“Effective treatment options are urgently needed for patients with unresectable liver cancer,” said Dr. Joerg Moeller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. “With sorafenib having been the only systemic option for the treatment of unresectable HCC since 2007, regorafenib could now become the second proven systemic option. We would like to thank the patients and the study investigators for their contributions and participation in this study.”
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.
About the Phase III Study
The RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] 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.
Patients received 160 mg regorafenib once daily, for 3 weeks on/1week off, or placebo with 28 days constituting one full treatment cycle. The primary endpoint of the study was overall survival, and secondary efficacy endpoints were time to progression, progression-free survival, objective tumor response rate and disease control rate. Safety and tolerability of patients were continuously monitored.
Filed Under: Drug Discovery