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Preliminary Results Announced From Phase 3 Study of Halaven (Eribulin Mesylate) in Breast Cancer
The phase III, open-label, randomized, parallel-arm, multicenter study was designed to evaluate Halaven versus capecitabine in 1,102 women with locally advanced or metastatic breast cancer who were previously treated with anthracyclines and taxanes. The patients were randomly assigned to receive treatment with either Halaven or capecitabine in accordance with their HER2 (human epidermal growth factor receptor type 2) status and geographic region.
Preliminary results showed that the trial did not meet the prespecified criteria for either of the co-primary endpoints of overall survival and progression-free survival. The study did show, however, a trend toward improved overall survival for patients who received Halaven compared with those who received capecitabine, but the improvement was not statistically significant. No difference was seen in progression-free survival. The safety profile of Halaven was consistent with that reported in previous clinical studies.
Eisai is conducting detailed analyses of the trial data, including the secondary endpoints and subgroup analyses prespecified in the study protocol, and will work closely with health authorities with regard to a potential regulatory filing.
Halaven is currently approved for the treatment of breast cancer in 37 countries worldwide, including the U.S., European Union member states, Japan, and Singapore. Phase III clinical trials evaluating Halaven for the additional indications of soft-tissue sarcoma and non–small-cell lung cancer are currently underway.
Read the news release here.