Eisai’s Phase III Results Of Eribulin Meets Primary Endpoint

Eisai announced preliminary results from a recently completed phase III study with eribulin mesylate (E7389), discovered and developed by the company, in patients with locally advanced or metastatic breast cancer.

Global phase III study, known as “EMBRACE,” (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389), was an open-label, randomised, parallel two-arm, multi-center study of 762 women with locally recurrent or metastatic breast cancer previously treated with at least two and a maximum of five prior chemotherapy regimens, including an anthracycline and a taxane.

The patients were treated either with eribulin or with treatment of physician’s choice. Treatment of physician’s choice is defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer or palliative treatment or radiotherapy administered according to local practice.

Preliminary results from the study demonstrated improvement in overall survival, the primary endpoint, in eribulin-treated patients compared with the physician’s choice of therapy. The safety profile of eribulin in this phase III study was consistent with the adverse events seen in previous phase II clinical studies and the most common adverse event reported was myelosuppression.

Eisai will complete a more detailed analysis of the data prior to submitting marketing authorisation applications for eribulin to health authorities in Japan, the US, and Europe for locally advanced and metastatic breast cancer by the end of the fiscal year 2009.