Eisai's eribulin meets Ph III primary endpoint; Japan, US and EU filings this year

Japanese drug major Eisai has announced preliminary results from a recently-completed Phase III study with in-house discovered E7389 (eribulin mesylate) in patients with locally advanced or metastatic breast cancer and updated on its regulatory filing aims for the drug.
T
his global Phase III trial, 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(1) 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 one and eight every 21 days) or with treatment of physician's choice.

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.

While early detection by breast cancer screening and the development of innovative anti-cancer drugs have contributed to the decline in breast cancer mortality around the world, breast cancer remains one of the leading causes of cancer death in women, the Japanese firm notes. Although advances are being made every year in the treatment of breast cancer, women with locally advanced or metastatic breast cancer have limited treatment options and the development of more effective treatment or anti-cancer drugs is critically important.

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

Eisai is currently conducting clinical trials of this compound in-house to evaluate the efficacy and safety not only in breast cancer, but also in non-small cell lung cancer (NSCLC), hormone refractory prostate cancer, and sarcoma. The company also includes eribulin as one of the compounds in the co-development projects based on the strategic collaboration agreement with Quintiles and will proceed with joint clinical development of this for NSCLC, as well as bladder cancer.