Eisai announces publication of Halaven Phase III study results against breast cancer in The Lancet journal

Eisai announced today that results from the global Phase III clinical study "EMBRACE" (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus Eribulin) will be published online in The Lancet. The EMBRACE study showed that Halaven (eribulin mesylate) Injection demonstrated a statistically significant increase in overall survival.

“There is a great need for therapies that improve survival in heavily pre-treated patients”

The U.S. Food and Drug Administration approved Halaven on November 15, 2010, for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included two common chemotherapy treatments, an anthracycline and a taxane, for early or advanced breast cancer.

"There is a great need for therapies that improve survival in heavily pre-treated patients," said study investigator Linda Vahdat, M.D., Professor of Medicine, Division of Hematology & Medical Oncology at the Iris Cantor Women's Health Center at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City. "These study results are significant because it appears to be the first time a single-agent study of a cytotoxic or biologic agent has shown a significantly increased survival benefit in this patient population."

The most common side effects (incidence ≥ 25%) reported by patients receiving Halaven were low white blood cells (82%), low red blood cells (58%), weakness/tiredness (54%), hair loss (45%), numbness, tingling or burning in the hands and feet (35%), nausea (35%) and constipation (25%). The most common serious side effects reported in patients receiving Halaven were neutropenia with or without fever (4% and 2%, respectively). The most common side effect resulting in discontinuation of treatment with Halaven was peripheral neuropathy (5%).

Results from the EMBRACE study were initially presented at the 46^th Annual Meeting of the American Society of Clinical Oncology Meeting (ASCO) in June 2010. This is the first time the EMBRACE investigators and Eisai have published the Phase III data in a peer-reviewed journal.

"We are pleased to see these compelling data about Halaven published in The Lancet," said Lonnel Coats, President & CEO, Eisai Inc. "The availability of this new treatment option reinforces our human health care mission to produce therapies that can help make a difference in the lives of patients and their families."

In addition to the United States, Halaven also recently obtained regulatory approval in Singapore. Regulatory applications are under review in Japan, the EU, Switzerland and Canada.

Source: Eisai