Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. announced the start of a Phase III study with Nexavar® (sorafenib) tablets in liver cancer.

The randomized, double-blind, placebo-controlled study is evaluating Nexavar as an adjuvant therapy for patients with hepatocellular carcinoma (HCC), or primary liver cancer. An adjuvant treatment is given as an additional systemic therapy after the initial tumor treatment, e.g. surgery, to fight cancer cells that may have spread.
The STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial aims to further build on earlier Phase III data, 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 U.S. and Europe at the end of 2007.

"Nexavar is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations," said Dimitris Voliotis, MD, Vice President, Nexavar Clinical Development, Bayer HealthCare. "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."

In addition, the U.S. Food and Drug Administration (FDA) has completed a Special Protocol Assessment (SPA) for the trial. An SPA is a written agreement between the FDA and the company that the design and size of a clinical trial are acceptable to support a New Drug Application for marketing in the United States.

Nexavar® targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is currently approved in more than 40 countries for liver cancer and in more than 70 countries for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.