Bayer HealthCare AG, Onyx Pharmaceuticals, Inc, OSI Pharmaceuticals, Inc and Roche announced the initiation of a phase-III trial examining Nexavar (sorafenib) tablets in combination with Tarceva (erlotinib) tablets as a potential new treatment option for 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 aims to further build on data from the Phase III SHARP trial, which demonstrated that Nexavar significantly extended overall survival in patients with unresectable liver cancer by 44 per cent. Based on the strength of these data, Nexavar was approved for the treatment of patients with unresectable HCC in the US and in Europe for the treatment of HCC. Nexavar is currently approved in more than 70 countries for the treatment of HCC, including China where more than half of all liver cancer cases worldwide occur each year.
"Nexavar is the only approved targeted therapy with efficacy and tolerability in liver cancer," said Dimitris Voliotis, vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "We look forward to seeing the potential of combining Nexavar with another effective cancer treatment, Tarceva, in treating this disease and further extending the lives of patients."
"This study will enable us to learn whether combining two oral targeted therapies, Nexavar and Tarceva, can improve survival in a disease that is difficult to treat since most patients are diagnosed at an advanced stage," said Karsten Witt, vice president, Clinical Development Oncology and Drug Safety, OSI Pharmaceuticals. "We are pleased to collaborate with Roche, Bayer and Onyx to explore Tarceva in HCC, a new disease area which if successful, has the potential to expand the use of Tarceva beyond its current indications in second/third-line non-small cell lung cancer and first-line pancreatic cancer."
Nexavar, an oral anti-cancer therapy, is currently approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer.
Tarceva is a once-a-day pill that targets the EGFR pathway. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR signalling pathway inside the cell, one of the critical growth factors in NSCLC and pancreatic cancers.
Onyx Pharma is a biopharmaceutical company committed to improving the lives of people with cancer.
OSI Pharma is committed to 'shaping medicine and changing lives' by discovering, developing and commercializing high-quality, novel and differentiated targeted medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity.