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Phase II Nexavar study looks promising

Nexavar in combination with chemotherapy demonstrates 74 per cent improvement in progression-free survival

Bayer HealthCare and Onyx Pharmaceuticals have announced the full results from their collaborative phase II trial showing that Nexavar (sorafenib tablets) in combination with the oral chemotherapeutic agent, capecitabine, extended progression-free survival in patients with advanced breast cancer by 74 per cent. The data were presented at the joint 15th European Cancer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) multidisciplinary congress in Germany.

The principal investigator in the study was Jose Baselga MD, chairman and Professor of Medicine at Vall d'Hebron Institute of Oncology in Barcelona, and scientific chairman of the Spanish Collaborative Group for the Study, Treatment and Other Experimental Strategies in Solid Tumours (SOLTI).

The difference in median progression-free survival of Nexavar plus capecitabine versus capecitabine plus placebo was statistically significant, at 6.4 months vs 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 programme."

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.

The randomised, double-blind, placebo-controlled study had 229 patients, all with locally advanced or metastatic HER-2 negative breast cancer and having 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 received 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 break from capecitabine.

23rd September 2009

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