Bayer HealthCare announced today that patient enrollment is underway for RESORCE (Regorafenib after Sorafenib in Patients with Hepatocellular Carcinoma), an international Phase III trial to evaluate the efficacy and safety of Stivarga® (regorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC) who have progressed on Nexavar® (sorafenib) tablets, an anticancer medicine for the treatment of patients with unresectable HCC. Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis and maintenance of the tumor microenvironment.
Stivarga has been approved by the U.S. Food and Drug Administration (FDA) for two different tumor types. In February 2013, the FDA approved Stivarga to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Last September, Stivarga was approved for the treatment of patients with metastatic colorectal cancer (mCRC) 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.
"There is an unmet need for HCC patients whose disease has progressed after treatment with sorafenib, the only oral systemic therapy shown to improve overall survival in patients with unresectable HCC," said Pamela A. Cyrus , MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "We look forward to sharing our findings with the scientific community."