Bayer’s Breast Cancer Drug Fails in Trial
According to the German drug company, Bayer, its breast cancer drug, Nexavar did not meat the primary endpoint goal in the Phase III trial. The researchers reported that Nexavar was not capable of prolonging the progression of advanced breast cancer.
In the study, which was titled Resilience, researchers examined the effects of taking Nexavar (sorfenib) tablets in combination with capecitabine, which is a chemotherapeutic agent. The female patients were all diagnosed with HER2-negative breast cancer that were either localized or had already metastasized. The patients had not responded to taxane or anthracycline therapy.
The trial design was a randomized, double-blind, placebo-controlled Phase III study that recruited 537 patients taken from over 20 different countries. The primary endpoint of the study was progression-free survival. Other endpoints were overall survival, disease progression time, overall response rate, disease control, response time, and patient-reported life quality.
"We are disappointed that the trial did not show an improvement in progression-free survival in patients with advanced breast cancer," said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development according to the Wall Street Journal. "While the primary endpoint of this trial was not met, the trial results do not affect the currently approved indications for NEXAVAR. We would like to thank the patients and the study investigators for their contributions and participation in this study."
The trial's findings are expected to be presented at an upcoming scientific congress.