Nexavar + capecitabine combination fails Phase III RESILIENCE trial for HER 2 negative Breast Cancer - Bayer + Onyx Pharma

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc., an Amgen subsidiary,announced that an investigational Phase III 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.