Nexavar to be given to all patients in Asia-Pacific trial after it boosts survival in HCC

Bayer Healthcare Pharmaceuticals, a US unit of Germany's Bayer, and US biopharmaceutical firm Onyx Pharmaceuticals say that a planned review by an independent data monitoring committee found that their co-developed cancer drug Nexavar (sorafenib) 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. 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 firms noted.

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 local patient populations. Supplemental regulatory filings have been completed in several regions including Europe, China and the USA for Nexavar in the treatment of this indication. 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, according to Bayer.

"Liver cancer incidence continues to rise in the Asia-Pacific region, due to the high prevalence of hepatitis B virus infection," said 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."