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Published on 22 July 2009

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Nexavar in combination with chemotherapy shown to extend progression-free survival

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Bayer HealthCare AG and Onyx Pharmaceuticals, Inc today announced that their first cooperative group-sponsored randomised 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. 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, M.D., 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.”

The randomised, double-blind, placebo-controlled phase II study evaluated Nexavar in combination with the oral chemotherapeutic agent, capecitabine, in 229 patients. These patients had locally advanced or metastatic HER-2 negative breast cancer and had received no more than one prior chemotherapy in this setting.

The primary endpoint of the study was progression-free
survival. There were several secondary endpoints including overall survival, time to progression, and safety. Patients were randomised to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to 1000mg/m2 of capecitabine twice daily for 14 days followed by a seven day rest from capecitabine.



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