The Lancet Publishes Results from Pivotal Study of Eisai's Halaven (Eribulin Mesylate) Injection in Patients with Late-Stage Metastatic Breast Cancer

Phase III Study Demonstrated that Halaven Met its Primary Endpoint of Overall Survival (OS)

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Mar 2, 2011 - 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 (hazard ratio 0.81, 95% CI 0.66-0.99; p=0.041) in women with late-stage metastatic breast cancer. When approximately 50% of events had been observed, results from the primary analysis demonstrated that patients treated with Halaven survived a median of 13.1 months (95% CI; 11.8-14.3) compared to 10.6 months (95% CI; 9.3-12.5) for patients who were treated with a single-agent therapy chosen by their physician.

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 46th 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.

About the Global Phase III Clinical Study (EMBRACE)

EMBRACE was an open-label, randomized, global, multi-center study designed to compare overall survival in patients treated with Halaven (1.4 mg/m2 administered intravenously for two-to-five minutes on days 1 and 8 of a 21-day treatment cycle) versus a treatment chosen by their physician (control group). The study, which was designed to reflect “real world” clinical practice, included 762 patients with metastatic breast cancer who previously had been treated with an average of four prior chemotherapies. Metastatic breast cancer is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body. Ninety-seven percent of patients in the control group received chemotherapy, including vinorelbine (26%), gemcitabine (18%), capecitabine (18%), taxane (16%), anthracycline (9%) and other chemotherapy (10%), while 3% of patients received hormonal therapy.

Important Safety Information about Halaven

Decreased White Blood Cells (Neutropenia)

A doctor should do a blood test to monitor patients' blood cells before they receive each dose of HALAVEN, and should monitor patients more often if they develop lower white blood cells. If patients develop severe neutropenia lasting longer than seven days or neutropenia with a fever, their next dose of HALAVEN should be delayed and reduced. Severe neutropenia occurred in 57% (287/503) of patients who received HALAVEN and lasted more than one week in 12% (62/503) of patients. Neutropenia with a fever occurred in 5% (23/503) of patients; two patients died from complications of neutropenia with a fever. Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Patients should call their healthcare provider immediately if they have any of the following symptoms: fever (temperature above 100.5 ºF), chills, coughing, burning or pain when they urinate.

Nerve Disorders (Peripheral Neuropathy)

HALAVEN can cause numbness, tingling, or burning in the hands and feet (peripheral neuropathy). Patients should be monitored closely for signs of neuropathy. If patients develop severe neuropathy, treatment with HALAVEN should be delayed until the neuropathy improves and the next dose of HALAVEN should be reduced. Severe peripheral neuropathy occurred in 8% (42/503) of patients who received HALAVEN. Neuropathy lasting more than one year occurred in 5% of patients. Twenty-two percent (109/503) of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days. Peripheral neuropathy was the most common side effect that caused patients to stop taking HALAVEN.

Pregnancy and Nursing

HALAVEN may harm an unborn baby. Patients should avoid becoming pregnant while receiving HALAVEN. Patients should tell their healthcare provider right away if they become pregnant or think they are pregnant while receiving HALAVEN. Patients and their healthcare providers should decide if they will take HALAVEN or breastfeed. They should not do both.

Heartbeat Changes

HALAVEN can cause changes in a patient's heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death. Healthcare providers will decide if patients need heart monitoring (electrocardiogram, or ECG) or blood tests during treatment with HALAVEN to watch for this problem.

Liver and Kidney Problems

In patients with mild or moderate liver problems, and/or moderate kidney problems, a lower starting dose of HALAVEN is recommended.

Please see the Halaven full prescribing information at www.halaven.com.

About Halaven (eribulin mesylate) Injection

Discovered and developed by Eisai, Halaven is a non-taxane, microtubule dynamics inhibitor that is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into nonproductive aggregates.

Halaven is indicated 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 an anthracycline and a taxane either in the adjuvant or metastatic setting.

Eisai Oncology

Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that may make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, vaccines, and biologic agents across various types of cancer.

Eisai is committed to helping patients gain access to its therapies. For more information about our reimbursement support and patient assistance programs, please call the Eisai Assistance Program at 1-866-61-EISAI between 8 a.m. and 8 p.m. ET Monday through Friday.

Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top 20 United States pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the United States pharmaceutical operation of Eisai Co., Ltd.

Eisai has a global product creation organization that includes United States-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include: neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.

Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.

For further information, please visit www.eisai.co.jp.

 

Contact: Media Inquiries:
Eisai Inc.
Judee Shuler
201-746-2241 (office)
or
Investor Inquiries:
Eisai Inc.
Dave Melin
908-255-6378 (cell)

 

Posted: March 2011

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