Published: June 06, 2010
Phase III Study Results Showed Eisai's Eribulin Mesylate Significantly Improved Overall Survival in Patients with Locally Recurrent or Metastatic Breast Cancer
CHICAGO - (BUSINESS WIRE) - Results of a Phase III study presented today at the American Society of
Clinical Oncology (ASCO) Annual Meeting showed that Eisai's eribulin
mesylate significantly improved median overall survival (OS) compared
with Treatment of Physician's Choice (TPC) in heavily pre-treated
metastatic breast cancer patients.
These results were presented as part of an ASCO-sponsored press
briefing; additional details from the study will be presented in an oral
session on June 8, 2010 at 9:30 a.m. in East Hall D1 at Chicago's
McCormick Place. The study abstract has also been selected for
presentation at the 2010 Best of ASCO Meetings, which will be held in
San Francisco and Boston in the United States and in several countries
around the world in the months following the ASCO Annual Meeting.
The Phase III "EMBRACE" study (Eisai Metastatic Breast Cancer Study
Assessing Physician's Choice Versus Eribulin E7389) met its primary
endpoint of overall survival, showing that patients who received
eribulin survived a median of 2.5 months longer than patients who
received TPC (overall survival of 13.12 months versus 10.65 months,
respectively, p=0.04). Results from EMBRACE also showed that
a secondary endpoint of overall response rate (ORR) was statistically
significant. Another secondary endpoint, progression free survival
(PFS), was supportive of the primary endpoint but did not reach
statistical significance.
"To date, no single-agent Phase III clinical trial has demonstrated
improved survival in women with heavily pre-treated metastatic breast
cancer," said Chris Twelves, M.D., lead investigator for the EMBRACE
study and Professor of Clinical Cancer Pharmacology and Oncology from
the University of Leeds and St. James's University Hospital, Leeds,
United Kingdom. "These results showed that eribulin significantly
improved overall survival versus a variety of agents used in a
real-world setting, which previously no single agent has shown."
The most frequently reported adverse events (AEs) among patients treated
with eribulin were asthenia, or fatigue (53.7%), neutropenia, or low
white blood cell counts (51.7%), alopecia, or hair loss (44.5%) and
peripheral neuropathy, or numbness and tingling in different parts of
the body (34.6%). Treatment-emergent serious AEs were reported for 25
percent of patients in the eribulin group and 25.9 percent of patients
in the TPC arm.
About the Study
EMBRACE was an open-label, randomized, multi-center study of 762
patients with locally recurrent or metastatic breast cancer who were
previously treated with at least two and a maximum of five prior
chemotherapies (≥2 for advanced disease), including an anthracycline and
a taxane. Patients must have been refractory to the most recent
chemotherapy, documented by progression on or within six months of
therapy. The study was designed to compare overall survival
in patients treated with eribulin versus a TPC arm, reflecting a
real-world clinical setting where a variety of agents are used to treat
patients with advanced breast cancer.
Patients were randomized in a two-to-one ratio to receive either
eribulin (1.4 mg/m2 administered intravenously for
two-to-five minutes on days 1 and 8 of a 21-day treatment cycle) or TPC.
TPC was defined as any single agent chemotherapy, hormonal treatment or
biological therapy approved for the treatment of cancer; or palliative
radiotherapy administered according to local practice. The
median age of study participants was 55 (range 27-85); 16 percent of
patients had HER2 positive breast cancer and 19 percent had breast
cancer that was negative for estrogen, progesterone and HER2 receptors
(triple-negative breast cancer).
About Metastatic Breast Cancer
Worldwide, more than one million women a year are diagnosed with breast
cancer. Approximately 50 percent of women worldwide initially diagnosed
with breast cancer are expected to develop recurrent or metastatic
disease within 15 years of their first diagnosis. Only one in five women
with metastatic breast cancer survives longer than five years. In
the United States, an estimated 155,000 women are currently living with
metastatic breast cancer, and that number is projected to increase to
162,000 by 2011.
"Women with advanced breast cancer are in critical need of new treatment
options," said Alton Kremer, M.D., Ph.D, Global Head of Clinical
Development for Oncology at Eisai Inc. "In this study, eribulin has
shown an improvement in survival, and if approved by health authorities,
it may offer patients a new treatment option at this stage of the
disease."
About Eribulin
Eribulin mesylate (E7389) is an investigational agent being evaluated as
a potential treatment for locally advanced or metastatic breast cancer.
A non-taxane, microtubule dynamics inhibitor, eribulin is a synthetic
analog of halichondrin B, which is derived from a natural product
isolated from the marine sponge Halichondria okadai.
On March 30, 2010, Eisai announced it had submitted simultaneous
regulatory applications for approval of eribulin mesylate for the
treatment of locally advanced or metastatic breast cancer to agencies in
Japan, the United States and the European Union (EU). The eribulin New
Drug Application (NDA) was granted priority review status by the U.S.
Food and Drug Administration (FDA) on May 28, 2010.
Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing
innovative oncology therapies that can 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, therapeutic vaccines, biologic
and supportive care agents for cancer across multiple indications.
Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S.
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 U.S. pharmaceutical operation of Eisai Co., Ltd.
Eisai has a global product creation organization that includes
U.S.-based R&D facilities in Maryland, 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 Europe, Ltd.
Eisai concentrates its R&D activities in three key areas:
-
Integrative Neuroscience, including: Alzheimer's disease, multiple
sclerosis, neuropathic pain, epilepsy, depression
-
Integrative Oncology, including: anticancer therapies; tumor
regression, tumor suppression, antibodies and supportive cancer
therapies; pain relief, nausea
-
Vascular/Immunological reaction, including: acute coronary syndrome,
atherothrombotic disease, severe sepsis, rheumatoid arthritis,
psoriasis, Crohn's disease
In Europe, Eisai undertakes sales and marketing operations in over 20
markets, including the United Kingdom, France, Germany, Italy, Spain,
Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway,
Portugal, Iceland, Czech Republic, Hungary and Slovakia.
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.
* Best of ASCO is a registered trademark of the American Society of
Clinical Oncology
Media Inquiries
Eisai Inc.
Judee Shuler
During
ASCO: 908-337-2540
201-746-2241 (office)
or
Eisai Europe
Ltd.
Cressida Robson
During ASCO: +44 7908 314 155
or
Investor
Inquiries
Eisai Inc.
Dave Melin
908-255-6378 (cell)
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