Phase 3 study of eribulin for locally advanced or metastatic breast cancer

Eisai announced preliminary results from a recently completed Phase 3 study with eribulin mesylate (E7389) in patients with locally advanced or metastatic breast cancer. This global study, known as EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389), was an open-label, randomized, parallel two-arm, multicenter 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 (administered intravenously over 2–5 minutes on days 1 and 8 every 21 days) or with a treatment of the physician's choice, 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 demonstrated a statistically significant improvement in the primary endpoint of overall survival in eribulin-treated patients compared with the physician's choice of therapy. The safety profile of eribulin in this Phase 3 study was consistent with the adverse events seen in previous Phase 2 clinical studies and the most common adverse event reported was myelosuppression.

Eribulin is a synthetic analog of halichondrin B, a naturally-derived compound that was first isolated from a marine sponge. While taxanes inhibit cell division by stabilizing microtubules, eribulin is a microtubule dynamics inhibitor that arrests the cell cycle through inhibition of the growth of microtubules without interfering with microtubule shortening.

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