Stivarga Improves Overall Survival in Hepatocellular Carcinoma Study
Bayer announced that the Phase 3 study, RESORCE, evaluating 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.
RESORCE (REgorafenib after SORafenib in patients with hepatoCEllular carcinoma) is a randomized, double blind, placebo-controlled, multicenter Phase 3 trial which evaluated the efficacy and safety of regorafenib in approximately 573 patients with HCC whose disease has progressed after treatment with sorafenib. Patients were randomized to receive either regorafenib 160mg once daily for 3 weeks on/1week off plus best supportive care (BSC) or placebo plus BSC. The primary efficacy endpoint was overall survival. Secondary endpoints included time to progression, progression-free survival, objective tumor response rate and disease control rate.
Preliminary data showed that treatment with regorafenib significantly improved overall survival, meeting the study's primary endpoint. The safety and tolerability were generally consistent with the known profile of regorafenib. Detailed study analyses are expected to be presented at an upcoming scientific congress.
Stivarga (regorafenib) is a kinase inhibitor currently indicated for the treatment of patients with metastatic colorectal cancer (CRC) 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, and for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
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