Eisai Inc. Announces Initiation Of A Phase 3 Trial Of Eribulin Mesylate Injection Versus Weekly Paclitaxel In First And Second Lines Of Metastatic Breast Cancer

WOODCLIFF LAKE, N.J., Feb. 27, 2014 /PRNewswire/ -- Eisai Inc. today announced the start of a large, randomized Phase 3 trial to compare the efficacy, safety and tolerability of eribulin mesylate to standard weekly paclitaxel as a first- or second- line treatment for HER2-negative locally recurrent or metastatic breast cancer (MBC). Recruitment is currently active for this multicenter study, conducted in partnership with the Academic and Community Cancer Research United (ACCRU) group, and aims to enroll approximately 910 patients across the U.S. The primary endpoint is overall survival.

This research study involves an investigational use of eribulin mesylate. The efficacy and safety of eribulin mesylate in first- and second-line MBC have not been established and this release is not intended to convey conclusions of efficacy and safety.

"As a human healthcare company, Eisai is committed to further exploring new treatments for metastatic breast cancer patients," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai.

About The Study
This study is for HER2-negative breast cancer patients who have received no more than one prior chemotherapy regimen once their breast cancer has spread. Eligible patients will be randomly selected with equal allocation (1:1) to receive treatment for their cancer with either eribulin mesylate or standard weekly paclitaxel, within strata defined by prior adjuvant taxanes, hormone receptor status (ER/PgR), and line of therapy.

The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival and objective tumor response rate. Safety and tolerability of the treatment groups will also be continuously monitored.

To learn more about this clinical trial, please visit www.clinicaltrials.gov/show/NCT02037529.

About Metastatic Breast Cancer
Metastatic breast cancer (MBC) 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 2013, an estimated 234,580 women will be diagnosed with breast cancer in the U.S. Approximately 30 percent of patients having an initial diagnosis of early-stage breast cancer will go on to develop recurrent, advanced or MBC.

About Eribulin Mesylate Injection
Eribulin mesylate injection (available as Halaven^®) is currently indicated for patients with breast cancer who have received at least two other types of 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. Eribulin 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.

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 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 Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

About ACCRU
The Academic and Community Cancer Research United (ACCRU) is a clinical research group whose operations are based at the Mayo Clinic Cancer Center in Rochester, Minn. ACCRU includes a network of more than 65 academic and community-based cancer treatment clinics and hospitals in the United States and Canada. ACCRU, formerly Mayo Clinic Cancer Research Consortium (MCCRC), was established in 2004 to conduct clinical trials to improve cancer care.

HALAVEN^® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

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SOURCE Eisai Inc.