SAN ANTONIO, Dec. 7, 2012 /PRNewswire/ -- Results from the first large, global Phase III study of Halaven(®) (eribulin mesylate) Injection in patients with early-stage metastatic breast cancer were presented today during the 2012 CTRC-AACR San Antonio Breast Cancer Symposium.

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The 1,102-patient, open-label, multi-center study compared Halaven versus capecitabine (Xeloda(®)) in women with locally advanced or metastatic breast cancer. The majority of the patients received study treatment as their first or second-line chemotherapy for metastatic disease, a different population than what was studied for FDA approval.

The study did not meet the co-primary endpoints for overall survival or progression-free survival. However, the data showed a trend toward improved overall survival in patients treated with Halaven with a median survival of 15.9 months versus 14.5 months with capecitabine (HR 0.879; 95% CI 0.770, 1.003; p=0.056). Progression-free survival was 4.1 and 4.2 months for eribulin and capecitabine, respectively (independent review; HR 1.079; 95% CI 0.932, 1.250; p=0.305).

Additionally, pre-specified exploratory subgroup analyses suggested a potential overall survival advantage for Halaven over capecitabine in certain patient populations based on receptor status. Further study is warranted.

Adverse events (AEs) were consistent with the known side-effect profiles of both drugs. The most common AEs for eribulin and capecitabine (> 20% all grades) were neutropenia (54.2% vs. 15.9%), hand-foot syndrome (0.2% vs. 45.1%), alopecia (34.6% vs. 4.0%), leukopenia (31.4% vs. 10.4%), diarrhea (14.3 vs. 28.8%) and nausea (22.2% vs. 24.4%), respectively.

"Though the study did not reach the statistical threshold required to prove superiority compared to capecitabine - a commonly used treatment in earlier lines of metastatic breast cancer - trends observed in certain patient populations that were treated with Halaven merit additional research, especially considering the unmet need in metastatic breast cancer," said Peter A. Kaufman, MD, one of the lead investigators of the study and Associate Professor of Medicine, Geisel School of Medicine at Dartmouth and an oncologist and hematologist at the Norris Cotton Cancer Center in Lebanon, New Hampshire.

About the Study
Study 301 was a global, open-labeled, randomized, two-parallel-arm, multi-center study of Halaven (eribulin mesylate) Injection versus capecitabine in 1,102 women with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes, either in the (neo) adjuvant setting or for locally advanced or metastatic disease. Patients in the study received zero to two previous chemotherapies for advanced disease.

Patients were randomized to treatment with either Halaven 1.4mg/m(2) (administered intravenously over two to five minutes on days 1 and 8, every 21 days) or capecitabine 2.5g/m(2) (administered orally twice daily in two equal doses on days 1 to 14, every 21 days).

About Halaven
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.

Important Safety Information

Decreased White Blood Cells (Neutropenia)
A doctor should do a blood test to monitor a patient's blood cells before they receive each dose of Halaven, and should monitor them more often if they develop lower white blood cells. If a patient develops severe neutropenia lasting longer than 7 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 1 week in 12% (62/503) of patients. Neutropenia with a fever occurred in 5% (23/503) of patients; 2 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 degrees F), chills, coughing, burning or pain when they urinate.

Nerve Disorders (Peripheral Neuropathy)
Halaven can cause numbness, tingling, or burning in a patient's hands and feet (peripheral neuropathy). A patient should be monitored closely for signs of neuropathy. If a patient develops 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 receiving Halaven.

Pregnancy and Nursing
Halaven may harm a patient's unborn baby. A patient should avoid becoming pregnant while they are receiving Halaven. A patient should tell their healthcare provider right away if they become pregnant or think they are pregnant while they are receiving Halaven. The patient and their healthcare provider should decide if they will receive Halaven or breastfeed. A patient 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. A patient's healthcare provider will decide if they need heart monitoring (electrocardiogram or ECG), or blood tests during their 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.

Most Common Side Effects
The most common side effects reported in >25% of 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 your 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 a fever (4% and 2%, respectively).

For full prescribing information for HALAVEN, please visit: http://www.halaven.com/sites/default/files/HALAVEN_full_Prescribing_Information.pdf

Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that can help 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 is to help address unmet medical needs and to increase the benefits health care provides to patients and their families. 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, biologic and supportive care agents for cancer across multiple indications.

Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai's key areas of commercial focus are neurology and oncology. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-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/US.

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 healthcare system.

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