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Nexavar® in Combination with Chemotherapy Demonstrates 74 Percent Improvement in Progression-Free Survival


First presentation of results at joint ECCO-ESMO congress in Berlin, Germany

Berlin. – Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo controlled Phase II trial showing that Nexavar® (sorafenib tablets) in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer by 74 percent. The data were presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress in Berlin, Germany.

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 chemotherapy alone. The difference in median progression-free survival of Nexavar plus capecitabine versus capecitabine plus placebo was statistically significant, 6.4 months vs. to 4.1 months (HR=0.576, p=0.0006).

“These data represent a potentially significant advance in the treatment of breast cancer, which is the second leading cause of cancer-related death in women,” said Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare. “In addition to the positive signal generated in this trial, Bayer and Onyx are committed to the development of Nexavar in breast cancer in a variety of settings through a robust clinical program.”

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 showed an acceptable tolerability, without any new side effects. Common grade 3 or 4 treatment-related adverse events included hand-foot skin reaction, diarrhea, dyspnea, neutropenia and mucositis.

Breast Cancer Phase-II-Trial Design
The randomized, double-blind, placebo-controlled Phase II study evaluated Nexavar in combination with the oral chemotherapeutic agent, capecitabine, in 229 patients. All patients had locally advanced or metastatic HER-2 negative breast cancer and 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. Patients were randomized to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to 1000 mg/m2 of capecitabine twice daily for 14 days followed by a seven day rest from capecitabine.

“Bayer and Onyx 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 an important step in understanding the potential role of Nexavar in breast cancer.”

About the Nexavar Clinical Program in Breast Cancer
In a clinical development program known as Trials to Investigate the Effects of Sorafenib in Breast Cancer (TIES), Nexavar is being evaluated in diverse treatment settings for patients with breast cancer in collaboration with investigators and cooperative groups. Among these clinical trials are three ongoing randomized Phase II studies, including a trial to evaluate Nexavar plus paclitaxel in the first-line setting, a trial to evaluate Nexavar plus gemcitabine or capecitabine in the first- or second-line setting following progression on bevacizumab, and a trial to evaluate Nexavar plus docetaxel and/or letrozole in the first-line setting.

About Breast Cancer
Breast cancer was the most commonly diagnosed cancer among women worldwide in 2007-2008 (approximately 1.3 million cases), and the second leading cause of cancer-related death among women (approximately 465,000 deaths). It is the most commonly diagnosed cancer among women in the United States (1 in 4 cancer diagnoses is breast cancer). There are approximately 200,000 new cases of breast cancer in the United States and 430,000 in Europe each year. More than 40,000 women in the United States and more than 130,000 in Europe die of breast cancer each year.


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