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Breast cancer; pooled analysis results of two Phase III Halaven® (eribulin) trials

The results from a pooled analysis of two Phase III Halaven(R) (eribulin) trials are published in Research and Treatment. Findings from the pooled analysis show that eribulin improves overall survival in women compared to control. This overall survival benefit was observed in women with human epidermal growth-factor receptor-2 (HER2) negative and triple negative (TNBC).[1]

“These pooled data show the overall survival benefit of eribulin in the important and often forgotten about HER2 negative and triple negative subtypes, who constitute the majority of patients with cancer. Chemotherapy remains the backbone of treatment for women with and this analysis confirms that these women benefit from eribulin,” comments 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 in 1,864 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, initially requested by the European Medicines Agency (EMA), was to assess overall survival in the overall intent to treat (ITT) population and in specific patient subgroups, previously treated with an anthracycline and a taxane, based on HER2 and hormone receptor status.

In the pooled analysis, eribulin was found to improve significantly overall survival vs. control in the ITT population (15.2 vs 12.8 months, HR=0.85 [95% CI, 0.77, 0.95]; p=0.003). A significant overall survival benefit was observed in women with 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 estimated 85% of women with breast cancer.[1],[4],[5] This overall survival benefit was also seen in people with 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).[1] There were no noticeable differences in the tolerability and safety data previously shown in the EMBRACE study (Study 305) and Study 301.[1]

On 3 July 2014, The European Commission (EC) issued Marketing Authorisation Approval (MAA) for eribulin in 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.[6] This decision was based on clinical evidence from EMBRACE (Study 305)[2] and Study 301.[3]