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Bayer HealthCare AG and Onyx Pharmaceuticals today announced results from a randomised, placebo-controlled phase II trial sponsored by Northwestern University.
The study, which evaluated Nexavar (sorafenib) tablets in combination with the chemotherapeutic agent paclitaxel in patients with locally advanced or metastatic HER-2 negative breast cancer, demonstrated a positive trend towards improvement of progression-free survival in the treatment group.
The safety and tolerability profile of the combination was consistent with previous experience with each agent and no new toxicities were observed. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting. Patients are continuing to be followed for a secondary
endpoint of overall survival.
The trial was led by principle investigator William Gradishar, professor of medicine, Robert H Lurie Comprehensive Cancer Center of Northwestern University. “These encouraging data warrant further investigation to determine the potential of the Nexavar and paclitaxel treatment combination in patients with advanced breast cancer, an often underserved patient population,” said Dr Gradishar.
“The preliminary results in this study demonstrate a clinical signal in favor of this treatment combination. These data require further analysis and interpretation before we determine the appropriate path forward,” said Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare.
“This trial is the second of four from our comprehensive clinical program in breast cancer, which is intended to explore Nexavar’s utility in a number of disease settings.”
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