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news.A phase III trial assessing Bayer's Stivarga (regorafenib) to treat unresectable hepatocellular carcinoma (HCC) has met its primary endpoint of a statistically significant improvement in overall survival.
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The study, dubbed Resorce, enrolled 573 subjects who were randomized 2:1 to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC.
Patients were treated with 160 mg of regorafenib once daily for three weeks on/one week off or placebo for 28 days.
The primary endpoint of the study was improved overall survival, which was reached, and secondary efficacy endpoints included time to progression, progression free survival, objective tumor response rate and disease control rate.
Bayer member of the executive committee for pharmaceutical division and head of development Joerg Moeller said: "Effective treatment options are urgently needed for patients with unresectable liver cancer.
"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."
Stivarga is a multi-kinase inhibitor, which blocks various enzymes that promote cancer growth.
In the US, Stivarga is indicated to treat metastatic colorectal cancer who have been earlier treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor who have been previously treated with imatinib mesylate and sunitinib malate.