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Pooled analysis of two Phase III Trials shows Halaven® (Eribulin) improves survival in advanced breast cancer
Significant survival benefit observed in women with HER2 negative breast cancer – ASCO Press Release. 
Data from a pooled analysis presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) provides further evidence that Halaven® (eribulin) improves overall survival (OS) in women with advanced breast cancer compared with other standard therapies (15.2 vs 12.8 months, HR=0.85 [95% CI, 0.77-0.95]; p=0.003).1 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, HR=0.82 [95% CI, 0.72-0.93]; p=0.002), a subtype that affects an estimate 85% of women with breast cancer.1
This OS benefit was also seen in people with triple negative breast cancer (TNBC), (12.9 vs 8.2 months, HR=0.74 [95% CI, 0.60-0.92]; p=0.006), but not in women with HER2 positive breast cancer (13.5 vs 12.2 months, HR=0.82 [95% CI, 0.62-1.06]; p=0.135). There were no noticeable differences in the tolerability and safety data previously shown in the EMBRACE and 301 studies.1
“Eribulin remains the only single agent chemotherapy proven to improve significantly overall survival in women with advanced breast cancer after either adjuvant or metastatic anthracycline and taxane treatment. These new data clearly confirm that women with advanced breast cancer benefit from eribulin. The overall survival benefit that was observed in HER2 negative and triple negative breast cancer patients is particularly interesting as very often these patients are underserved with few effective treatment options,” commented Dr Chris Twelves, Professor of Clinical Cancer Pharmacology and Oncology and Honorary Consultant in Medical Oncology at the University of Leeds and St James’s Institute of Oncology.
The pooled analysis examined data from two pivotal Phase III studies of more than 1,800 women; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician’s Choice Versus Eribulin)2 and study 301.3 The objective of the analysis, requested by the European Medicines Agency (EMA), was to assess OS in the overall intent to treat (ITT) population and in subgroups based on HER2 and hormone receptor status.
A total of 12 abstracts have been accepted at this year’s ASCO congress highlighting the ongoing clinical development of eribulin in women with difficult to treat metastatic breast cancer sub-types, in combination with other agents and in different therapeutic areas.
On 27 May 2014, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for eribulin for the treatment of patients with locally advanced or metastatic breast cancer (MBC) who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
1. Twelves C, Cortes J et al. Efficacy of eribulin in patients with metastatic breast cancer: a pooled analysis by HER2 and ER status. Presented at ASCO 2014. Poster #: 95
2. Cortes J, O’Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011;377:914-923
3. Kaufman P, Awada A, Twelves C et al. A Phase III, open-label, randomised, multicenter study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes. Presented at 2012 CTRC-AACR San Antonio Breast Cancer Symposium
