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

Hatfield, England (ots/PRNewswire) -

Eisai Europe Limited today announces preliminary results from a
recently completed Phase III study (Study 301) comparing Halaven(R)
(eribulin) and Xeloda(R) (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/m2 (administered
intravenously over two to five minutes on days 1 and 8, every 21
days) or capecitabine 2.5g/m2(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(R) (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.or
g.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+Tabl
ets /

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

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media Enquiries: Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44-(0)7947-231513 / +44-(0)790-831-4155 ,
Charlotte_andrews@eisai.net / Cressida_robson@eisai.net . Tonic Life
Communications: Benjamyn Tan / Leah Peyton, +44-(0)207-798-9262 /,
+44-(0)7788-191434, benjamyn.tan@toniclc.com,
eisaioncology@toniclc.com