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

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Eisai Announces Preliminary Results of Phase III Study of Halaven® (Eribulin) in Locally Advanced or Metastatic Breast Cancer PR Newswire HATFIELD, England, July 10, 2012 HATFIELD, England, July 10, 2012 /PRNewswire/ -- Eisai Europe Limited today announces preliminary results from a recently ®completed Phase III study (Study 301) comparing Halaven (eribulin) and ®Xeloda (capecitabine). The study enrolled women with locally advanced or metastatic breast cancer in an earlier line of treatment than eribulin is currently licensed for. Preliminary results showed that 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). However, the study did show a trend towards improved OS for patients who received eribulin compared with capecitabine, but the improvement was not statistically significant. No difference was seen in PFS. Furthermore, safety was consistent with the known profile of eribulin. Eisai plans to conduct a detailed analysis of the clinical trial data including the secondary endpoints and subgroups pre-specified in the study protocol and will work with the regulatory authorities towards potential regulatory filings. Further study results will be submitted for presentation at forthcoming international medical meetings. "With over 1,100 women with advanced breast cancer studied, this is one of the largest studies ever conducted in this patient population.
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Eisai Announces Preliminary Results of Phase
III Study of Halaven® (Eribulin) in Locally
Advanced or Metastatic Breast Cancer
PR Newswire
HATFIELD, England, July 10, 2012
HATFIELD,
England
,
July 10, 2012
/PRNewswire/ --
Eisai Europe Limited today announces preliminary results from a recently
completed Phase III study (Study 301) comparing Halaven
®
(eribulin) and
Xeloda
®
(capecitabine). The study enrolled women with locally advanced or
metastatic breast cancer in an earlier line of treatment than eribulin is
currently licensed for. Preliminary results showed that 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). However, the study did show
a trend towards improved OS for patients who received eribulin compared with
capecitabine, but the improvement was not statistically significant. No
difference was seen in PFS. Furthermore, safety was consistent with the known
profile of eribulin.
Eisai plans to conduct a detailed analysis of the clinical trial data including the
secondary endpoints and subgroups pre-specified in the study protocol and will
work with the regulatory authorities towards potential regulatory filings. Further
study results will be submitted for presentation at forthcoming international
medical meetings.
"With over 1,100 women with advanced breast cancer studied, this is one of the
largest studies ever conducted in this patient population. There are important
trends here that will need further analysis. Eisai remains committed to
evaluating the safety and efficacy of eribulin in patients living with locally
advanced or metastatic breast cancer. This continues to be an area of
significant unmet medical need in women with advanced disease", said Kenichi
Nomoto, President, Oncology Product Creation Unit at Eisai.
The global Phase III trial (Study 301), was an open-label, randomised, two-
parallel-arm, multicentre 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 who have had zero to two previous
chemotherapies for advanced disease. Patients who have previously received
capecitabine were excluded from the study. Patients were randomised at a
ratio of 1:1 to receive treatment with either eribulin 1.23mg/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), the regulatory approved recommended doses.
[1,2]
Study 301 is the second large Phase III trial studying OS for eribulin compared
to a standard treatment. Data from the first study, EMBRACE, presented in
2010 evaluated the role of eribulin in a later stage population compared to
Treatment of Physician Choice (TPC).
[3]
Eribulin is the first and only single-agent therapy proven to significantly extend
overall survival after two prior lines of metastatic breast cancer therapy when
compared to other single-agent therapies.
[3]
Results from a pivotal Phase III
study (EMBRACE) demonstrated a statistically significant overall survival benefit
for patients treated with eribulin compared with a single-agent TPC. The
primary analysis, conducted when ~55.4% of deaths (eribulin [274], TPC [148])
had been observed, demonstrated a median OS for eribulin vs TPC of 13.1
months (95% CI: 11.8, 14.3) vs 10.6 months (95% CI: 9.3, 12.5), (
P
=0.041). The
updated overall survival analysis was consistent with the primary analysis.
[3]
Eribulin is currently indicated in
Europe
for the treatment of patients with locally
advanced or metastatic breast cancer who have previously received at least
two chemotherapeutic regimens. Prior therapy should have included an
anthracycline and a taxane unless patients were not suitable for these
treatments.
[1]
Eribulin received European Commission approval on
17 March 2011
based on
the results of the Phase III EMBRACE study. Eribulin is approved in the European
Union,
USA
,
Switzerland
,
Japan
, and
Singapore
. In
Europe
, eribulin is currently
commercially available in
Austria
,
Denmark
,
Estonia
,
France
,
Finland
,
Germany
,
Iceland
,
Ireland
,
Italy
,
Japan
,
Luxembourg
,
Netherlands
,
Norway
,
Poland
,
Sweden
,
Switzerland
, and the
United Kingdom
.
In addition to the preliminary Phase III data announcement, Eisai announces
that the French authorities has granted reimbursement for the use of eribulin in
heavily pretreated women with metastatic breast cancer, recognising the
innovative nature of the treatment and the clinical value it may offer women.
Eisai also announces that it is expanding its footing in the Israeli market with
the registration grant of eribulin.
Notes to Editors
Halaven
®
(eribulin)
Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the
treatment of patients with breast cancer who have previously received at least
two chemotherapeutic regimens for metastatic disease and whose prior
therapy should have included an anthracycline and a taxane.
[1]
Eribulin
belongs to a class of antineoplastic agents, the halichondrins, which are natural
products, 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 non-productive aggregates.
Metastatic Breast Cancer
Metastatic breast cancer is an advanced stage of the disease that occurs when
cancer spreads beyond the breast to other parts of the body. In
Europe
,
approximately 6% of breast cancers are metastatic at diagnosis with a five-
year survival rate of 21%.
[4]
Eisai in Oncology
Eisai 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, and biologic and supportive
care agents for cancer across multiple indications.
About Eisai
Eisai is one of the world's leading R&D-based pharmaceutical companies and
has defined its corporate mission as "giving first thought to patients and their
families and to increasing the benefits health care provides," which we call
human health care (hhc).
Eisai recently expanded their UK Hatfield facility
which now supports the company's growing European, Middle Eastern, African
and Russian (EMEA) business.
Eisai concentrates its R&D activities in three key areas:
Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain,
epilepsy, depression
Oncology including: anticancer therapies; tumour regression, tumour suppression,
antibodies, etc and supportive cancer therapies; pain relief, nausea
Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic
disease, rheumatoid arthritis, psoriasis, Crohn's disease
With operations in the U.S.,
Asia
,
Europe
and its domestic home market of
Japan
, Eisai employs more than 11,000 people worldwide. 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
,
Slovakia
,
the Netherlands
,
Belgium
,
Luxembourg
,
Middle East
and
Russia
.
For further information please visit our web site http://www.eisai.com
July 2012
/ Halaven-UK0012
References
1. Halaven (eribulin) SPC available from:
http://www.medicines.org.uk/EMC/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/
(Updated
May 2012
)
2. Xeloda (capecitabine) SPC available from:
http://www.medicines.org.uk/EMC/medicine/4619/SPC/Xeloda+150mg+and+500mg+Film-
coated+Tablets/
3. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus
treatment of physician's choice in patients with metastatic breast cancer
(EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011; 377:
914 -923
4. Cardoso, M. and Castiglione F. Locally recurrent or metastatic breast cancer:
ESMO Clinical Recommendations for diagnosis, treatment and follow-up. On
behalf of the ESMO Guidelines Working Group. Ann Oncol (2009) 20 (suppl 4):
iv15-iv18