Bayer has announced that a phase III trial evaluating its oncology compound Stivarga (regorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma 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 hepatocellular carcinoma 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, a press release said.
The RESORCE [Regorafenib after sorafenib in patients with hepatocellular carcinoma] clinical trial is a randomised, double blind, placebo controlled, multicentre phase III study of regorafenib in patients with hepatocellular carcinoma whose disease has progressed after treatment with sorafenib. The trial enrolled approximately 573 patients who were randomised in a 2:1 ratio to receive either regorafenib plus best supportive care or placebo plus best supportive care.
Patients received 160mg regorafenib once daily, for three weeks on/one week 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 tumour response rate and disease control rate. The safety and tolerability of patients were continuously monitored.
Bayer plans to submit this data as the basis for marketing authorisation of regorafenib in the treatment of unresectable hepatocellular carcinoma.