Nexavar Improved Overall Survival in Asia-Pacific Liver Cancer Trial

A review by an independent data monitoring committee (DMC) found that Nexavar tablets significantly improved overall survival, progression-free survival and time to progression in an Asia-Pacific regional Phase III trial of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer, Bayer Healthcare and Onyx Pharmaceuticals announced.

Based on the DMC’s recommendation, the trial will be stopped to allow all patients to receive treatment with Nexavar (sorafenib), Bayer said.

The Asia-Pacific 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 Asian-Pacific patient populations, the company said.

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 company said. The primary objectives of the study were to compare overall survival, progression free survival and time to progression in patients administered Nexavar 400 mg twice daily versus patients administered placebo.

The company has completed supplemental regulatory filings in several countries and regions including Europe, China and the U.S. for Nexavar in the treatment of liver cancer. These filings were based on positive data from the pivotal Phase III SHARP study announced earlier this year. Additional regulatory submissions for Nexavar in liver cancer are being finalized, Bayer said.