Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced results from a Phase 2b trial evaluating Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic breast cancer previously treated with a bevacizumab-containing regimen, which showed that Nexavar was associated with statistically significant improvements in progression-free survival (the primary endpoint of the study) and time-to-progression. The study evaluated Nexavar in combination with a chemotherapeutic agent, either gemcitabine or capecitabine. The data will be presented on June 6, 2011, at 11:45 a.m. during the oral abstract session at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.
Clifford Hudis, M.D., Chief of the Breast Cancer Medicine Service and attending physician at the Memorial Sloan-Kettering Cancer Center, as well as Professor of Medicine at Weill Cornell Medical College, reported that patients receiving Nexavar in addition to standard chemotherapy agents obtained a progression-free survival benefit with median of 3.4 months to progression.
"These results demonstrate the importance of continuing to evaluate antiangiogenic compounds in breast cancer, and their study should remain a high priority for the research community," said Dr. Hudis.
"These data are similar to those observed in our previous Phase 2 trial evaluating Nexavar in combination with capecitabine," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development and Technical Operations for Onyx Pharmaceuticals. "Onyx and Bayer 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).
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