Bayer HealthCare AG and Onyx Pharmaceuticals, Inc announced that their first cooperative group-sponsored randomized phase-II trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival. The study evaluated Nexavar (sorafenib) tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer.

Study findings demonstrated that the median progression-free survival was extended in patients treated with Nexavar and capecitabine compared to patients receiving capecitabine and placebo. These results were statistically significant (p-value = 0.0006). In this trial, the safety and tolerability of the combination was as expected and did not show any new or unexpected toxicities. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting.

"Based on these encouraging data, Bayer and Onyx are evaluating various strategies for Nexavar in breast cancer. Nexavar is already benefiting patients worldwide with liver cancer and kidney cancer," said Kemal Malik, member of the Bayer HealthCare executive committee and chief medical officer. "Despite significant treatment advances, breast cancer continues to be the leading cause of cancer death in women. We hope to establish Nexavar as an important new treatment option for patients with this devastating disease."

"This outcome represents a positive signal of the benefit of this combination for patients with advanced breast cancer and is the first statistical demonstration of efficacy for a multi-tyrosine kinase inhibitor in this disease," said Jose Baselga, chairman and professor of medicine at Vall d'Hebron Institute of Oncology in Barcelona and the principle investigator of this study. "One goal of this study was to evaluate the success of an all oral regimen, which may represent a unique treatment option for patients with breast cancer."

Nexavar is being evaluated in collaboration with investigators and cooperative groups in a variety of treatment settings for patients with breast cancer.

Nexavar, an oral anti-cancer therapy, is currently approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer.

Onyx Pharma is a biopharmaceutical company committed to improving the lives of people with cancer.