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Stivarga Increases Overall Survival in Patients with Unresectable HCC
Bayer announced results of its phase 3 RESORCE clinical trial, indicating Stivarga improved overall survival in patients with unresectable hepatocellular carcinoma.
In the trial, 573 patients with HCC whose disease progressed after treatment with Nexavar (sorafenib, Bayer HealthCare) were treated with either 160 mg of Stivarga (regorafenib, Bayer) for 3 weeks on and 1 week off, or placebo with 28 days constituting one full treatment cycle, according to a press release.
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.
The release further states that the safety and tolerability of the drug were consistent with the known profile of regorafenib.
“Effective treatment options are urgently needed for patients with unresectable liver cancer,” Joerg Moeller, MD, head of development and member of the executive committee of Bayer AG's pharmaceutical division, said in the release. “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.”
Results from efficacy and safety analyses from RESORCE are expected to be presented at an upcoming scientific congress, according to the release.
Regorafenib is currently indicated in the U.S. for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy, and for patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor who have been previously treated with imatinib mesylate and sunitinib malate, according to the release.
Disclosure: Moeller is employed by Bayer.