Bayer and partner Onyx Pharmaceuticals have announced the start of a new late-stage study of Nexavar for use as an adjuvant therapy in patients with liver cancer.

The STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial aims to further build on earlier Phase III data, the companies say, which demonstrated a significant improvement in overall survival in patients with unresectable liver cancer. Based on the strength of these data, Nexavar was approved for HCC in the USA and Europe at the end of 2007, having already been on the market for advanced kidney cancer.

The drug "is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations,” said Dimitris Voliotis, vice president of Nexavar clinical development at Bayer. “Liver cancer is the third largest global cause of cancer-related deaths worldwide and there is a significant need for new therapies that can be used at all stages in the course of the disease to delay progression and prolong life.”

Noting that there are currently no adjuvant therapies, ie used after surgery, with proven benefit for HCC, Bayer and Onyx said that the STORM trial will enrol about 1,100 patients. It will evaluate whether adjuvant treatment with oral Nexavar delays the time to recurrence and improves overall survival.

Nexavar has become a major earner for Bayer and generated 108 million euros to second-quarter sales, up 80%.