BERLIN—Bayer HealthCare and Onyx Pharmaceuticals (Emeryville, California) have halted the phase III Asia-Pacific liver cancer study after a planned review by an independent data monitoring committee found that sorafenib(Drug information on sorafenib) (Nexavar) tablets significantly improved overall survival, progression-free survival, and time to progression in patients with advanced hepatocellular carcinoma. All study patients can now receive treatment with sorafenib, the companies said in a press release.
The Asia-Pacific liver cancer study was conducted at the request of Asian health authorities in order to provide supplemental information on sorafenib's efficacy and safety in Asian-Pacific patient populations.
The double-blind, randomized, placebo-controlled trial enrolled 226 HCC patients who had no prior systemic therapy from sites in China, Korea, and Taiwan. Patients received either sorafenib 400 mg twice daily or placebo. Sorafenib targets members of two classes of kinases known to be involved in both cell proliferation and angiogenesis.
The FDA has granted priority review to Nexavar for the treatment of HCC, based on data from the phase III SHARP study showing that the agent extended overall survival by 44%, compared with placebo.The drug is currently FDA approved for use in advanced kidney cancer.
