Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals Inc., an Amgen subsidiary, announced that an investigational Phase 3 trial of sorafenib (Nexavar) tablets plus capecitabine in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).
The study, called RESILIENCE, evaluated the efficacy and safety of sorafenib in combination with capecitabine, an oral chemotherapeutic agent, compared to placebo plus capecitabine, in patients with HER2 negative breast cancer who are resistant to or have failed prior taxane, and are resistant to or have failed an anthracycline or for whom further anthracycline therapy is not indicated. Based on initial review of the data, the types of adverse events observed were generally comparable with those known for either sorafenib or capecitabine. Detailed efficacy and safety analyses from this study are expected to be presented at an upcoming scientific congress.
“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. “While the primary endpoint of this trial was not met, the 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.”
Date: July 25, 2014
Source: Bayer HealthCare