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Addition Of Tarceva® (erlotinib) To Nexavar® (sorafenib) Did Not Provide Additional Benefit To Patients With Unresectable Liver Cancer Versus Nexavar Alone In Phase 3 Trial

WAYNE, N.J., SOUTH SAN FRANCISCO, Calif. and TOKYO, July 23, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX), and Astellas Pharma Inc. (TSE: 4503) today announced that a Phase 3 trial evaluating the efficacy and safety of the addition of Tarceva ® (erlotinib) tablets to Nexavar ® (sorafenib) tablets did not improve overall survival for patients with unresectable hepatocellular carcinoma (HCC) vs. Nexavar alone. The SEARCH ( S orafenib and E rlotinib, a r A ndomized t R ial proto C ol for the treatment of patients with H epatocellular carcinoma) trial compared Nexavar in combination with Tarceva to Nexavar alone. The safety and tolerability of the treatment combination were generally as expected based upon experience and use of the two products alone and there were no new or unexpected toxicities or changes to the respective product safety profiles observed. Data from this study will be presented at an upcoming scientific meeting. Nexavar is jointly developed by Bayer and Onyx. Tarceva is jointly marketed by Astellas and Genentech, a member of the Roche Group.

"The data from SEARCH showed that the addition of Tarceva to Nexavar did not provide additional benefit to patients with unresectable HCC," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare. "The results of this trial confirm the efficacy and safety profile of Nexavar in the treatment of unresectable liver cancer."

About the Phase 3 Study

The SEARCH trial was an international multicenter placebo-controlled Phase 3 study that randomized 720 patients with advanced liver cancer. The study examined whether the addition of Tarceva to Nexavar prolongs survival as compared to Nexavar alone in patients with unresectable HCC. The primary endpoint of the study was overall survival (OS) and the secondary endpoints were safety, time to radiographic progression (TTP), disease control rate (DCR) and patient-reported outcome.  Patients were randomized to receive either 400 mg of Nexavar twice daily and 150 mg of Tarceva once daily or 400 mg of Nexavar twice daily with matching placebo. 

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