Phase 2 study of Nexavar for the treatment of advanced breast cancer

NEXAVAR (sorafenib) 200mg tablets from Bayer and Onyx
NEXAVAR (sorafenib) 200mg tablets from Bayer and Onyx
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced the full results from their first Phase 2 trial of Nexavar (sorafenib tablets) in combination with the oral chemotherapeutic agent, capecitabine for the treatment of advanced breast cancer. This randomized, double-blind, placebo-controlled study enrolled 229 patients with locally advanced or metastatic HER-2 negative breast cancer who had received no more than one prior chemotherapy. The primary endpoint of the study was progression-free survival. Secondary endpoints included overall survival, time to progression, and safety. Positive results from this study showed that Nexavar in combination with capecitabine, significantly extended progression-free survival in patients with advanced breast cancer by 74 percent compared to those who received chemotherapy alone. The difference in median progression-free survival of Nexavar plus capecitabine versus capecitabine plus placebo was statistically significant, 6.4 months vs. 4.1 months (HR=0.576, p=0.0006).

Nexavar is a multikinase inhibitor indicated for the treatment of advanced renal cell carcinoma and unresectable hepatocellular carcinoma.

For more information call (800) 288-8371 or visit www.nexavar.com.