Phase 2 trial results of Bayer's Nexavar in combination with capecitabine announced

Sep 23 2009

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trial showing that Nexavar(R) (sorafenib) tablets in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer. The data were presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress in Berlin.

Jose Baselga, M.D., chairman and professor of medicine at Vall d'Hebron Institute of Oncology in Barcelona, scientific chairman of SOLTI and the principal investigator of this study, reported that patients receiving Nexavar plus capecitabine had a 74 percent improvement in the time they lived without their disease progressing compared to those who received the 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>

"Onyx and Bayer have built a strong foundation with Nexavar in treating unresectable liver cancer and advanced kidney cancer - both disease areas with a previously unmet treatment need," said Todd Yancey, M.D., vice president of clinical development at Onyx. "These new results signify another step in understanding the potential role of Nexavar in breast cancer."

The study evaluated Nexavar in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Overall, treatment with Nexavar plus capecitabine was tolerable and resulted in no new side effects. Common grade 3 or 4 treatment-related adverse events included hand-foot skin reaction, diarrhea, dyspnea, neutropenia and mucositis.