Bayer initiates Ph III Stivarga study in liver cancer; Sanofi enrolls sarilumab patients

German drug major Bayer (BAYN: DE) says 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) for the treatment of patients with hepatocellular carcinoma (HCC) who have progressed on Nexavar (sorafenib) tablets, an anticancer drug for the treatment of patients with unresectable HCC.

Stivarga has been approved by the US Food and Drug Administration for two different tumor types. In February 2013, the FDA cleared 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.1

Sanofi and Regeneron update on two Ph III trials with sarilumab in RA