Phase 3 study of Nexavar and Tarceva for primary liver cancer

Bayer HealthCare, Onyx Pharmaceuticals, OSI Pharmaceuticals and Roche announced the initiation of a Phase 3 trial examining Nexavar (sorafenib tablet, from Bayer and Onyx) in combination with Tarceva (erlotinib tablet, from Genentech) for the treatment of patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer. The SEARCH (Sorafenib and erlotinib, a randomized trial protocol for the treatment of patients with hepatocellular carcinoma) trial is an international multicenter, randomized, placebo-controlled study expected to enroll about 700 patients with advanced liver cancer. The study will examine whether Nexavar in combination with Tarceva prolongs survival as compared to Nexavar alone. The primary endpoint of the study is overall survival and the secondary endpoints are safety, time to radiographic progression, disease control rate and patient-reported outcome.

Nexavar is an oral multikinase inhibitor targeting both the tumor cell and tumor vasculature. Tarceva is a once-daily oral formulation designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cell.

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