Eisai Inc. today 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.
This global Phase III study, known as "EMBRACE," (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389), was an open-label, randomized, 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 (administered intravenously over two to five minutes on days 1 and 8 every 21 days) 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 a statistically significant 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.
Eribulin is a new chemical compound discovered and developed by Eisai. It is a synthetic analogue 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.