Onyx, Bayer initiate patient enrollment in Nexavar Phase 3 trial for breast cancer treatment

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the companies have begun enrolling patients in a Phase 3 randomized, double-blind, placebo-controlled 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."

Phase 3 Trial Design

The RESILIENCE (Phase 3 TRial Comparing CapecitabinE in Combination with SorafenIb or PLacebo for Treatment of Locally Advanced or MetastatIc HER2–Negative Breast CancEr) 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.

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, M.D., Executive Vice President and Head of Research and Development and Technical Operations for Onyx Pharmaceuticals.