(ChemotherapyAdvisor) – Addition of Tarceva® (erlotinib) to Nexavar® (sorafenib) did not provide additional benefit to patients with unresectable liver cancer in a phase 3 trial, according to a July 23 press release jointly published by Bayer HealthCare Pharmaceuticals (Wayne, NJ), Astellas Pharma Inc. (Tokyo, Japan), and Onyx Pharmaceuticals, Inc. (South San Francisco, CA).
The phase 3 trial known as SEARCH (Sorafenib and Erlotinib, a rAndomized tRial protoCol for the treatment of patients with Hepatocellular carcinoma) trial compared sorafenib in combination with erlotinib to sorafenib alone. An international, multicenter, placebo-controlled, randomized study involving 720 patients with advanced liver cancer, SEARCH end points were overall survival (primary) and secondary were safety, time to radiographic progression, disease control rate and patient-reported outcome. In the study, randomized patients received either sorafenib (400mg, twice daily) and erlotinib (150mg, once daily) or sorafenib (400mg, twice daily plus matching placebo).
The combination therapy did not improve survival in this patient population. However, safety and tolerability were generally as expected based upon experience and use of the two products alone; no new or unexpected toxicities or changes to the respective product safety profiles were observed.
Data from this study will be presented at an upcoming scientific meeting.