Bayer HealthCare and Onyx Pharmaceuticals have announced the full results from the randomised, 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%.
The randomised, 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 randomised to receive 400mg of oral Nexavar or matching placebo twice daily, in addition to 1000mg/m2 of capecitabine twice daily for 14 days followed by a seven day rest from capecitabine.
Jose Baselga, chairman and professor of medicine at Vall d’Hebron Institute of Oncology in Barcelona, scientific chairman of SOLTI and the principal investigator of the study, said: “Patients receiving Nexavar plus capecitabine had a 74% 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).
Dimitris Voliotis, vice president of global clinical development oncology at Bayer HealthCare, said: “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. 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.”
Nexavar, an oral anti-cancer therapy, is currently approved in 80 countries for liver cancer and in more than 90 countries for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.