Nexavar misses primary endpoint
Bayer and partner Onyx’s multi-tyrosine kinase and RAF-1-inhibitor sorafenib (Nexavar) may not significantly slow hepatocellular carcinoma (HCC) progression in responders (=25% tumor shrinkage or necrosis) to transarterial chemoembolisation (TACE), the firms said on the weekend at the meeting for the American Society of Clinical Oncology Gastrointestinal Cancers in Orlando. The drug missed the primary endpoint of significantly increasing time to progression in a phase III trial conducted with 456 patients in Japan and Korea. Median time to progression or recurrence was 5.4 months in the sorafenib arm, and 3.7 months in the placebo arm. Overall survival was similar in the two groups. The researchers concluded that further study evaluating the safety and efficacy of sorafenib in combination with TACE is warranted; it is also approved for the treatment of liver cancer without TACE (more...), and for the treatment of advanced kidney cancer. Additionally, researchers from France and Canada have reported that patients with advanced renal cell cancer (RCC) and treated with Nexavar® (sorafenib) showed muscle wastage. The details of this study have appeared in an early online publication in the Journal of Clinical Oncology. In April, the companies announced that sorafenib tosylate had failed in a phase III trial conducted as a first-line therapy in melanoma patients (more...).