Emeryville, Calif — Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have begun enrolling patients in a Phase 3 trial evaluating Nexavar (sorafenib) tablets in combination with the oral chemotherapeutic agent, capecitabine, versus placebo plus capecitabine for the treatment of patients with advanced breast cancer. This Phase 3 trial was initiated based on the results from a cooperative group-sponsored Phase 2 clinical trial evaluating Nexavar in combination with capecitabine in patients with advanced breast cancer.

"This Phase 3 trial is an important milestone in our development of Nexavar as it provides an opportunity to evaluate Nexavar in this patient population," said Dr. Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare. "We look forward to continuing our breast cancer clinical trial program, which includes two ongoing cooperative group-sponsored Phase 2 trials."

The Phase 3 trial is a randomized, double-blind, placebo-controlled Phase 3 study planned to enroll 519 patients in more than 20 countries including the United States, Brazil, Japan and Australia. The study will evaluate Nexavar in combination with capecitabine in patients with locally advanced or metastatic HER-2 negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline is not indicated. The primary endpoint of the study is progression-free survival. Secondary endpoints include overall survival, time to progression, and safety. For more information regarding this trial refer to www.clinicaltrials.gov (NCT 01234337).

"Nexavar has demonstrated efficacy in advanced kidney cancer and unresectable liver cancer and we are committed to evaluating Nexavar in a variety of treatment settings and tumor types," said Ted W. Love, MD, executive vice president and Head of Research and Development and Technical Operations for Onyx Pharmaceuticals.

The Trials to Investigate the Effects of Sorafenib in Breast Cancer (TIES) program is a cooperative group-sponsored clinical development program evaluating Nexavar in a variety of treatment settings for patients with breast cancer conducted by investigators and oncology cooperative groups. Among these clinical trials are two ongoing randomized Phase 2 studies, including a trial to evaluate Nexavar plus gemcitabine or capecitabine in the second-line setting following progression on bevacizumab and a trial to evaluate Nexavar plus docetaxel and/or letrozole in the first-line metastatic breast cancer setting.

Nexavar is approved in the United States for the treatment of patients with unresectable liver cancer and for the treatment of patients with advanced kidney cancer. Nexavar inhibits both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to inhibit members of two classes of kinases thought 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.

SOURCE Onyx Pharmaceuticals, Inc