Bayer HealthCare and its partners Onyx Pharmaceuticals, OSI Pharmaceuticals and Roche have announced the initiation of a phase III clinical trial for Nexavar (sorafenib) liver cancer tablets.
Bayer sees the tablets used in combination with Tarceva (erlotinib), as a potential new treatment option for patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer.
The trial will aim to 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%.
OSI Pharmaceuticals vice president of clinical development oncology and drug safety Karsten Witt said that this study would enable the group 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,” said Witt.
Based on the data demonstrated by Nexavar, the treatment has been approved for patients with unresectable HCC in the US and in Europe.