Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals and Astellas Pharma have reported results from a Phase 3 trial evaluating 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) versus Nexavar alone.
Bayer HealthCare global clinical development oncology vice president Dr Dimitris Voliotis said the data from the SEARCH trial demonstrated 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.
The SEARCH (Sorafenib and Erlotinib, a rAndomized tRial protoCol for the treatment of patients with Hepatocellular carcinoma) trial compared Nexavar in combination with Tarceva to Nexavar alone.
Patients in the SEARCH trial 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.
According to the company, no new or unexpected toxicities or changes to the respective product safety profiles were observed.
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.
