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Nexavar in Combination With Chemotherapy Demonstrates Activity in Patients With Advanced Breast Cancer in Two Phase 2 Studies
Date:12/11/2009

WAYNE, N.J. and EMERYVILLE, Calif., Dec. 11 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced results from two collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trials were presented at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). The first of these studies evaluated Nexavar® (sorafenib) tablets in combination with chemotherapy agent capecitabine and the second study evaluated Nexavar in combination with paclitaxel.

"Onyx and Bayer are encouraged by these results as they suggest Nexavar may have potential as a combination therapy for advanced breast cancer patients in both the first and second-line setting," said Todd Yancey, M.D., senior vice president of clinical development at Onyx. "These findings, in particular the statistically significant results demonstrated with Nexavar in combination with capecitabine, are the basis for a registrational Phase 3 program that is expected to begin next year."

Nexavar in Combination with Capecitabine

The randomized, double-blind, placebo-controlled Phase 2 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.

Patients receiving capecitabine plus Nexavar had a 74 percent improvement in progression-free survival as compared to those who received chemotherapy alone. The increase in median progression-free survival of capecitabine plus Nexavar versus capecitabine plus placebo was statistically significant (median 6.4 months vs. 4.1 months, HR=.576, p=0.0006).

In a post-hoc, subgroup analysis of first-line pati
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SOURCE Onyx Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals Inc.
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