Nexavar in Combination with Chemotherapy Shown To Extend Progression-Free Survival in Patients with Advanced Breast Cancer
Statistically Significant Results Reported from a Phase II Study Combining Two Oral Cancer Therapies
Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that their first cooperative group-sponsored randomized Phase II trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival. The study evaluated Nexavar® (sorafenib) tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Study findings demonstrated that the median progression-free survival was extended in patients treated with Nexavar and capecitabine compared to patients receiving capecitabine and placebo. These results were statistically significant (p-value = 0.0006). In this trial, the safety and tolerability of the combination was as expected and did not show any new or unexpected toxicities. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting.
“Based on these encouraging data, Bayer and Onyx are evaluating various strategies for Nexavar in breast cancer. Nexavar is already benefiting patients worldwide with liver cancer and kidney cancer,” said Kemal Malik, member of the Bayer HealthCare Executive Committee and Chief Medical Officer.
“This outcome represents a positive signal of the benefit of this combination for patients with advanced breast cancer and is the first statistical demonstration of efficacy for a multi-tyrosine kinase inhibitor in this disease,” said Jose Baselga, M.D., chairman and professor of medicine at Vall d'Hebron Institute of Oncology in Barcelona and the principle investigator of this study. “One goal of this study was to evaluate the success of an all oral regimen, which may represent a unique treatment option for patients with breast cancer.”
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