Interim data analysis found that primary endpoint of improving overall survival would not be reached.
Bayer Healthcare and Onyx Pharmaceuticals stopped a Phase III trial of Nexavar after predicting that the cancer drug would not improve survival in patients with unresectable stage III or stage IV melanoma.
Patients in the study received either twice-daily doses of Nexavar or placebo along with carboplatin and paclitaxel over a period of 10 cycles, followed by a maintenance phase of Nexavar or placebo.
Nexavar targets cell proliferation and angiogenesis in combating cancers. It is currently approved in more than 70 countries for liver cancer and in more than 80 countries for kidney cancer. In 2008, net sales reached $678 million, a 82% growth over 2007.
Bayer and Onyx continut to study nexavar in various combinations and in different stages of liver and kidney cancer. Additionally, the companies are investigating the drug’s potential in breast and non-small-cell lung cancer.
Under their collaboration and co-promotion agreements, Onyx funds 50% of worldwide development, except Japan. The two companies co-promote Nexavar in the U.S., sharing equally in profits or losses. Everywhere else in the world, except in Japan, Bayer has exclusive marketing rights, and the firms share profits 50/50. In Japan, Bayer funds all product development and Onyx will receive a royalty.