Based on the DMC’s recommendation, the trial will be stopped to allow all patients to receive treatment with Nexavar. Data from this study will be submitted for presentation at an upcoming scientific meeting.
The liver cancer study was conducted at the request of Asian health authorities in order to provide supplemental information on Nexavar’s efficacy and safety in Asia-Pacific patient populations. Supplemental regulatory filings have been completed in several countries/regions including Europe, China and the US for Nexavar in the treatment of liver cancer. Additional regulatory submissions for Nexavar in liver cancer are being finalized.
“Liver cancer incidence continues to rise in the Asia-Pacific region, due to the high prevalence of hepatitis B virus infection,” said Dr Ann-Lii Cheng, principal investigator and professor of medicine, National Taiwan University Hospital. “These study results confirm that Nexavar’s efficacy and tolerability in liver cancer extends across ethnic groups and geographies and suggest that Nexavar could meet a tremendous unmet need for patients and families impacted by this devastating disease.”
The double-blind, randomized, placebo-controlled Phase III trial was designed to evaluate Nexavar in patients with advanced HCC, or primary liver cancer, who had no prior systemic therapy. The study enrolled 226 patients from sites in China, Korea and Taiwan. The primary objectives of the study were to compare overall survival, time to progression (TTP) and progression free survival (PFS) in patients administered Nexavar 400mg twice daily versus patients administered placebo.