Phase III data shows Halaven improves OS in Breast Cancer - Eisai

Data from a pooled analysis provides evidence that Halaven (eribulin), from Eisai, improves overall survival (OS) in women with advanced Breast Cancer compared with other standard therapies (15.2 vs 12.8 months). In particular, a significant OS benefit was observed in women with human epidermal growth-factor receptor-2 (HER2) negative Breast Cancer (15.2 vs 12.3 months), a subtype that affects an estimated 85% of women with breast cancer. This OS benefit was also seen in people with triple negative Breast Cancer (TNBC), (12.9 vs 8.2 months), but not in women with HER2 positive Breast Cancer (13.5 vs 12.2 months). There were no noticeable differences in the tolerability and safety data previously shown in the EMBRACE and 301 studies.

Dr Chris Twelves, Professor of Clinical Cancer Pharmacology and Oncology and Honorary Consultant in Medical Oncology at the University of Leeds presented data from two pivotal Phase III studies of more than 1,800 women; EMBRACE and study 301 at ASCO. The objective of the analysis, requested by the European Medicines Agency, was to assess OS in the overall intent to treat population and in subgroups based on HER2 and hormone receptor status.