THOUSAND OAKS (dpa-AFX) - Bayer HealthCare Pharmaceuticals Inc., a subgroup of Bayer AG (BAYZF.PK, BAYRY.PK, BYR.L), and Onyx Pharmaceuticals Inc., an subsidiary of Amgen (AMGN), reported that an investigational Phase 3 study of NEXAVAR or sorafenib tablets in patients with advanced breast cancer failed to achieve its primary endpoint of improving progression-free survival or PFS.
The RESILIENCE (Phase 3 TRial Comparing CapecitabinE in Combination with SorafenIb or PLacebo for Treatment of Locally Advanced or MetastatIc HER2-Negative Breast CancEr) trial was a randomized, double-blind, placebo-controlled Phase III study which enrolled 537 patients in over 20 countries, including the U.S., Europe, Japan and Australia.
The RESILIENCE trial assessed the efficacy and safety of sorafenib in combination with capecitabine, an oral chemotherapeutic agent, compared with placebo plus capecitabine, in patients with HER2-negative breast cancer who are resistant to or have failed prior taxane therapy, and resistant to or failed 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.
The trial data are likely to be presented at an upcoming scientific congress.
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