The 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%.
Based on the data demonstrated by Nexavar, it was approved for the treatment of patients with unresectable HCC in the US and in Europe for the treatment of HCC.
Karsten Witt, Vice President, Clinical Development Oncology and Drug Safety at OSI Pharmaceuticals, said: “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.
“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.