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news.Eisai has announced preliminary results of Phase III study of Halaven (eribulin mesylate) injection in locally advanced or metastatic breast cancer.
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The trial included 1,102 women with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes either in the (neo) adjuvant setting or for locally advanced or metastatic disease.
The open-label, randomised study failed to meet the pre-specified criteria for either of the co-primary endpoints of overall survival (OS) and progression-free survival (PFS).
Eisai Oncology Product Creation Unit president Kenichi Nomoto said the study was a head-to-head comparison designed to show superiority against a commonly used drug approved in an earlier line of therapy than the FDA-approved indication for Halaven.
"Eisai remains committed to evaluating the safety and efficacy of eribulin in patients living with locally advanced or metastatic breast cancer, an area of significant unmet medical need," Nomoto added.
According to the company, study observed a trend toward improved OS for patients who received Halaven compared with capecitabine, but the improvement was not statistically significant. No difference was reported in PFS.
The company is conducting an analysis of the data, such as the secondary endpoints and subgroups pre-specified in the study protocol, and is planning to discuss the data with health authorities for regulatory filing.