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Phase 3 Trial Initiated to Evaluate Combination Therapy of Nexavar(R) andTarceva(R) in Patients with Liver Cancer

Thu, 05/28/2009 - 4:33am
Bayer HealthCare LLC., Onyx Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc. and Roche todayannounced the initiation of a Phase 3 trial examining Nexavar(R) (sorafenib)tablets in combination with Tarceva(R) (erlotinib) tablets as a potential newtreatment option for patients with advanced hepatocellular carcinoma (HCC), orprimary liver cancer. The SEARCH (Sorafenib and erlotinib, a randomized trial protocol for thetreatment of patients with hepatocellular carcinoma) trial aims to furtherbuild on data from the Phase 3 SHARP trial, which demonstrated that Nexavarsignificantly extended overall survival in patients with unresectable livercancer by 44 percent (HR0.69; p-value0.0006). Based on the strength ofthese data, Nexavar was approved for the treatment of patients withunresectable HCC in the United States and in Europe for the treatment of HCC.Nexavar is currently approved in more than 70 countries for the treatment ofHCC, including China where more than half of all liver cancer cases worldwideoccur each year. "Nexavar is the only approved targeted therapy with efficacy andtolerability in liver cancer," said Dimitris Voliotis, MD, vice president,Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "We lookforward to seeing the potential of combining Nexavar with another effectivecancer treatment, Tarceva, in treating this disease and further extending thelives of patients." "This study will enable us to learn whether combining two oral targetedtherapies, Nexavar and Tarceva, can improve survival in a disease that isdifficult to treat since most patients are diagnosed at an advanced stage,"said Karsten Witt, M.D., Vice President, Clinical Development Oncology andDrug Safety, OSI Pharmaceuticals. "We are pleased to collaborate with Roche,Bayer and Onyx to explore Tarceva in hepatocellular carcinoma, a new diseasearea which if successful, has the potential to expand the use of Tarcevabeyond its current indications in second/third-line non-small cell lung cancerand first-line pancreatic cancer."
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