Eisai Announces Preliminary Results of Phase III Study of Halaven® (eribulin mesylate) Injection in Locally Advanced or Metastatic Breast Cancer

WOODCLIFF LAKE, N.J., July 9, 2012 /PRNewswire/ -- Eisai Inc. today announced preliminary results from a recently completed phase III study of Halaven versus capecitabine (Xeloda®) in women with locally advanced or metastatic breast cancer. The trial did not meet the pre-specified criteria for either of the co-primary endpoints of overall survival (OS) and progression-free survival (PFS). The study did show, however, a trend toward improved OS for patients who received Halaven compared with capecitabine, but the improvement was not statistically significant. No difference was seen in PFS.

Eisai is conducting a detailed analysis of the data, including the secondary endpoints and subgroups pre-specified in the study protocol, and plans to discuss the data with health authorities toward potential regulatory filing. Full study results will be submitted for presentation at an upcoming medical meeting.  

"It is important to note that this was a head-to-head comparison designed to show superiority against a commonly used drug approved in an earlier line of therapy than the FDA-approved indication for Halaven," said Kenichi Nomoto, President, Oncology Product Creation Unit at Eisai. "We will look closely at the full data results to determine meaningful learnings for the medical community. Eisai remains committed to evaluating the safety and efficacy of eribulin in patients living with locally advanced or metastatic breast cancer, an area of significant unmet medical need."

The global phase III trial (Study 301) was an open-label, randomized, two-parallel-arm, multicenter study of 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. The study included patients with zero to two previous chemotherapies for advanced disease. Patients were randomized at a ratio of 1:1 to receive treatment with Halaven or capecitabine in accordance with their HER2/neu status and geographic region.  Patients received either Halaven 1.4mg/m2 (administered intravenously over two to five minutes on days 1 and 8, every 21 days) or capecitabine 2.5g/m2/day (administered orally twice daily in two equal doses on days 1 to 14, every 21 days).

Adverse events observed in the trial were consistent with the known safety profile of Halaven found in the full prescribing information.

About HALAVEN

Halaven is a non-taxane, microtubule dynamics inhibitor that is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. Halaven is indicated for patients with breast cancer who have received at least two other types of anticancer medicines for their breast cancer once it has spread. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer.

The FDA approval of Halaven in November 2010 was supported by results from EMBRACE, a phase III, randomized (2:1), open-label, multicenter, multinational trial in patients with metastatic breast cancer.

EMBRACE demonstrated a statistically significant OS benefit for patients treated with Halaven compared with a single-agent Treatment of Physician's Choice.

Important Safety Information

• Decreased White Blood Cells (Neutropenia)
  • Doctors should do blood tests to monitor patients' blood cells before they receive each dose of HALAVEN, and should monitor them more often if they develop lower white blood cells.
  • If patients develop 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% of patients who received HALAVEN and lasted more than 1 week in 12% of patients.
  • Neutropenia with a fever occurred in 5% 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 providers 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). Patients should be monitored closely for signs of neuropathy. If they 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% of patients who received HALAVEN. Neuropathy lasting more than one year occurred in 5% of patients. 22% 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. Patients must avoid becoming pregnant while they are receiving HALAVEN. They should tell their healthcare providers right away if they become pregnant or think they are pregnant while they are receiving HALAVEN.
  • Patients and their healthcare providers should decide if they will receive 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 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).

Please see the HALAVEN full prescribing information

About Metastatic Breast Cancer

Metastatic breast cancer is the form of the disease that refers to the most advanced stage, in which cancer cells break away from the tumor in the breast, spread to other parts of the body and continue growing. In 2012, an estimated 226,870 women will be diagnosed with breast cancer in the U.S. and approximately 30 percent of patients having an initial diagnosis of early-stage breast cancer will go on to develop recurrent, advanced or metastatic breast cancer.

About Eisai Inc.

As a research-based human health care (hhc) company, Eisai defines oncology as a therapeutic area of focus and 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.

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 areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. 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.

HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. Xeloda® is a registered trademark of Hoffmann-LaRoche Inc.

SOURCE Eisai Inc.