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Nexavar in Combination with Chemotherapy Improves Progression-Free Survival in Patients with Advanced Breast Cancer in Phase 2 Study
Date:5/18/2011

r are continuing to explore Nexavar's potential utility in breast cancer through a Phase 3 trial evaluating Nexavar in combination with capecitabine in advanced breast cancer in 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."

The safety and tolerability profile of the combination was consistent with the previous experience. The most commonly reported treatment-emergent Grade 3/4 adverse events were hand-foot skin reaction (39 percent), neutropenia (21 percent) and stomatitis (10 percent).

Phase 2b Trial Design

This Phase 2b randomized, double-blind, placebo-controlled trial evaluated Nexavar in combination with chemotherapeutic agents, gemcitabine (1000 mg/m2) or capecitabine (1000 mg/m2) in 160 patients with locally advanced or metastatic HER-2 negative breast cancer who were previously treated with a bevacizumab-containing regimen. Patients were randomized to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to chemotherapeutic agents – gemcitabine or capecitabine. The primary endpoint was progression-free survival, and secondary endpoints included overall survival, time-to-progression and safety.

"We continue to explore the utility of Nexavar as a potential treatment option for breast cancer patients in variety of settings, including in the ongoing RESILIENCE Phase 3 trial," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare.  "As the second leading cause of cancer-related death in women, there is still an unmet need for treatments for these advanced patients.  We remain committed to evaluating Nexavar in this patient population."

About the RESILIENCE Phase 3 Breast Cancer Trial

The RESILIENCE trial is
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SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.
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