Nexavar sees very strong Ph III data in HCC

German drug major Bayer AG and the USA's Onyx Pharmaceuticals have reported unexpected positive data on their co-developed anticancer drug Nexavar (sorafenib). The independent data monitoring committee has reviewed the safety and efficacy data from the companies' pivotal Phase III study in advanced hepatocellular carcinoma, or primary liver cancer, and concluded that the trial met its primary endpoint of superior overall survival versus placebo.

On the day of the news, February 12, Onyx shares almost doubled, climbing $11.89 to a 52-week high of $24.15, while shares in Bayer fell 0.5% to 44.37 euros.

Based on the results, the DMC recommended that the trial be stopped early to allow all patients access to Nexavar. The drug is already approved in the USA for the treatment of kidney tumors and the firms said that, given the limited systemic therapies for this new indication, they will continue discussions with health authorities worldwide to get the drug approved as soon as possible. The companies plan to present the trial results at the annual meeting of the American Society of Clinical Oncology, to be held in June.