Bayer has reported positive results from a Phase III clinical trial of its oncology compound stivarga (regorafenib) tablets to treat patients with unresectable hepatocellular carcinoma (HCC).
HCC is the most common form of liver cancer, which reportedly represents 70% to 85% of liver cancer across the world.
Bayer has stated that the trial, called REgorafenib after SORafenib in patients with hepatoCEllular carcinoma (Resorce), met its primary endpoint of a statistically significant improvement in overall survival.
The trial evaluated the efficacy and safety of regorafenib in patients with HCC whose disease has progressed after treatment with nexavar (sorafenib) tablets, co-developed by Bayer.
In the US, stivarga is indicated to treat metastatic colorectal cancer (CRC) patients, who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
During the Resorce trial, the safety and tolerability were generally consistent with the known profile of regorafenib.
The study is a randomised, double blind, placebo controlled, multicentre Phase III study and enrolled around 573 patients who were randomised in a 2:1 ratio, to receive either regorafenib along with best supportive care (BSC) or placebo and BSC.
In the trial, patients received 160mg regorafenib once daily, for three weeks on / one week off, or placebo with 28 days constituting one full treatment cycle.
Secondary efficacy endpoints of the trial were timed to progression, progression-free survival, objective tumour response rate and disease control rate. Safety and tolerability of patients were also continuously monitored.
Bayer seeks to submit data from the Resorce trial as the basis for marketing authorisation of regorafenib in the treatment of unresectable HCC this year.