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Bayer, Onyx, Astellas report Phase 3 HCC trial results

Bayer HealthCare, Onyx Pharmaceuticals and Astellas Pharma have reported results from Phase 3 Sorafenib and Erlotinib, a rAndomized tRial protoCol for the treatment of patients with Hepatocellular carcinoma (SEARCH) trial in patients with unresectable liver cancer.

The trial evaluated the efficacy and safety of the addition of Tarceva (erlotinib) tablets to Nexavar (sorafenib) tablets for patients with unresectable liver cancer.

The addition of Tarceva tablets to Nexavar did not improve overall survival for patients with unresectable hepatocellular carcinoma (HCC) vs. Nexavar alone.

Bayer HealthCare global clinical development oncology vice president Dimitris Voliotis said the data from SEARCH showed that the addition of Tarceva to Nexavar did not provide additional benefit to patients with unresectable HCC.

"The results of this trial confirm the efficacy and safety profile of Nexavar in the treatment of unresectable liver cancer," Voliotis added.

Patients were randomised with either 400mg of Nexavar twice daily and 150mg of Tarceva once daily or 400mg of Nexavar twice daily with matching placebo.

The overall survival was the primary endpoint while the secondary endpoints were safety, time to radiographic progression, disease control rate and patient-reported outcome.

Bayer and Onyx jointly developed Nexavar, which is approved in the US for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma. Tarceva is jointly marketed by Astellas and Genentech.