Halaven® (Eribulin) Now Available in Russia for Advanced Breast Cancer After Only One Prior Chemotherapy, Which Provides New Therapy for Women Living With Aggressive Disease

Hatfield, England (ots/PRNewswire) -

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/U.S. JOURNALISTS

Eisai is pleased to announce that women with locally advanced or
metastatic breast cancer (MBC) in Russia will have earlier access to
Halaven(R) (eribulin). Eribulin is now indicated for patients with
locally advanced or metastatic breast cancer who have progressed
after at least one chemotherapeutic regimen for advanced disease.
Prior therapy should have included an anthracycline and a taxane in
either the adjuvant or metastatic setting, unless patients were not
suitable for these treatments.[1]

"The new licence for eribulin in Russia will give physicians and
women with advanced breast cancer more options in earlier treatment.
Eribulin remains the only single-agent chemotherapy proven to prolong
overall survival in women with pre-treated metastatic breast cancer,"
commented Professor Vera Gorbunova, MD, head of the chemical therapy
department at the Russian Blokhin Oncologic Research Centre.

In Russia, breast cancer is the most common cause of death in
women aged 45-55 years, and that has increased by 64% over the last
20 years alone. Furthermore, approximately 50,000 Russian women are
newly diagnosed with breast cancer each year with around one in every
eight women at risk of developing the disease.[2]

"Eisai is pleased that the Russian health authorities have
recognised the benefit of earlier use of eribulin therapy in women
with HER2-negative metastatic breast cancer. More must be done for
these women who actually make up the majority of advanced disease
cases. We are committed to championing the needs of these women and
broadening access to eribulin to help redress the inequality between
HER2-negative and HER2-positive breast cancer outcomes in Russia and
across Europe," said Gary Hendler, President & CEO Eisai EMEA.

The new indication for eribulin follows Marketing Authorisation
Approval (MAA) for earlier use in advanced disease from the European
Commission on 3 July 2014. The decision is based on clinical evidence
from two global Phase III trials; EMBRACE (Eisai Metastatic Breast
Cancer Study Assessing Treatment of Physician's Choice Versus
Eribulin)[3] and study 301.[4] These studies involved more than 1,800
women.

EMBRACE showed eribulin can prolong median overall survival in
heavily pre-treated women with MBC compared to women receiving an
alternative treatment of physician's choice by 2.7 months (13.2 vs
10.5 HR 0.81 (95% CI 0.67, 0.96) nominal p=0.014). The most commonly
reported adverse reactions in the eribulin study arm are fatigue
(asthenia), a decrease in infection-fighting white blood cells
(neutropenia), hair loss (alopecia), numbness and tingling in arms
and legs (peripheral neuropathy), nausea and constipation.[3 ]
EMBRACE is one of only 25 studies to demonstrate a significant
extension in overall survival (as primary or secondary endpoint) in
MBC in the last 40 years.[5]

Study 301, a head-to-head trial of eribulin vs capecitabine, had a
co-primary endpoint of overall survival and progression-free
survival. The study demonstrated a trend favouring improved overall
survival with eribulin compared to capecitabine in the
intention-to-treat population, although the improvement was not
statistically significant.[4] Women treated with eribulin had a
median overall survival of 15.9 months versus 14.5 months with
capecitabine (HR 0.879; 95% CI: 0.770-1.003; p=0.056).[4] For women
with human epidermal growth factor receptor 2 (HER 2) negative
metastatic breast cancer, overall survival was 15.9 months vs 13.5
months for capecitabine (HR 0.838; 95% Cl: 0.715-0.983).[4] The most
common adverse events reported for eribulin and capecitabine (greater
than or equal to20% all grades) were neutropenia (54% vs 16%),
hand-foot syndrome (<1% vs 45%), alopecia (35% vs 4%), leukopenia
(31% vs 10%), diarrhoea (14 vs 29%) and nausea (22% vs 24%),
respectively.[4]

Eisai is dedicated to discovering, developing and producing
innovative oncology therapies that can make a difference and impact
the lives of women 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.

Notes to Editors

Halaven(R) (eribulin)

Eribulin is a non-taxane, microtubule dynamics inhibitor currently
indicated for the treatment of people 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.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 which
prevents cell division.

Global Phase III Clinical Study 305 (EMBRACE)[3]

EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment
of Physician's Choice (TPC) Versus Eribulin E7389) was an open-label,
randomised, global, multi-centre, parallel two-arm study designed to
compare overall survival in women treated with eribulin versus a TPC
arm. TPC was defined as any single-agent chemotherapy, hormonal
treatment or biologic therapy approved for the treatment of cancer;
or palliative treatment or radiotherapy administered according to
local practice. The study included 762 participants with metastatic
breast cancer who previously had been treated with at least two and a
maximum of five prior chemotherapies, including an anthracycline and
a taxane. The vast majority (96%) of participants in the TPC arm
received chemotherapy.

In the total phase III EMBRACE study population, eribulin was
shown to prolong median overall survival in heavily pre-treated women
with metastatic breast cancer compared to women receiving TPC by 2.7
months (13.2 vs 10.5 HR 0.81 (95% CI 0.67, 0.96) nominal p=0.014). A
pre-planned analysis of participants from Region 1 of the study
(North America/Western Europe/Australia) showed a significant median
overall survival benefit of eribulin over TPC of 3.0 months (nominal
p=0.031).

The most commonly reported adverse reactions among people treated
with eribulin in the EMBRACE study were fatigue (asthenia), a
decrease in infection-fighting white blood cells (neutropenia), hair
loss (alopecia), numbness and tingling in arms and legs (peripheral
neuropathy), nausea and constipation. Peripheral neuropathy was the
most common adverse event leading to discontinuation from eribulin,
occurring in less than 5% of the women involved in the EMBRACE trial.
Neutropenia only led to eribulin discontinuation for 0.6%. Death due
to serious side effects, discontinuation and dose interruptions to
treatment were lower in the eribulin arm of the trial compared with
the TPC arm.

Global Phase III Study 301[4]

Study 301 was an open-labelled, randomised, two-parallel-arm,
multicentre study of eribulin versus capecitabine in 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. Women in the study
received zero to two previous chemotherapies for advanced disease.

The study opened in 2006 and the last patient was randomised in
2010. Patients were randomised to 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).

Study 301 had a co-primary endpoint of OS and PFS. The study
demonstrated a trend favouring improved OS with eribulin compared to
capecitabine in the ITT population, although the improvement was not
statistically significant. Women treated with eribulin had a median
OS of 15.9 months (HR 0.879; 95% CI: 0.770-1.003; p=0.056) versus
14.5 months with capecitabine. The trial did not meet the
pre-specified endpoint for progression-free survival, with 4.1 and
4.2 months for eribulin and capecitabine respectively (HR 1.079; 95%
CI: 0.932-1.250; p=0.305).

1-, 2- and 3- year overall survival rates for eribulin versus
capecitabine showed an early improvement which was maintained
throughout the study (1 year, 64.4% eribulin vs 58.0% capecitabine
(P=0.0351), 2 year 32.8% eribulin vs 29.8% capecitabine (P=0.324), 3
year, 17.8% eribulin vs 14.5% capecitabine (P=0.175).

Unlike studies conducted today, study 301 included all women
regardless of their human epidermal growth factor receptor 2 (HER2),
oestrogen receptor (ER) or progesterone receptor (PR) status.
Patients are usually tested for their HER2 status as there are now
effective treatments specifically for patients with the HER2
mutation. HER2 positive patients would generally be treated with
anti-HER2 positive targeted therapy. For women with HER2 negative
metastatic breast cancer (n=755), OS was 15.9 months for eribulin vs
13.5 months for capecitabine (HR 0.838; 95% CI: 0.715-0.983). In the
HER2 positive population (n=169), OS was 14.3 months for eribulin vs
17.1 months for capecitabine (HR; 95% 0.965; CI: 0.688-1.355).

Adverse events in Study 301 were consistent with the known profile
of both drugs.

Metastatic Breast Cancer

Metastatic disease is an advanced stage of the disease that occurs
when cancer spreads beyond the breast to other parts of the body.

Eisai in Oncology

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 Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based
pharmaceutical company headquartered in Japan. We define our
corporate mission as "giving first thought to patients and their
families and to increasing the benefits health care provides," which
we call our human health care (hhc) philosophy. With over 10,000
employees working across our global network of R&D facilities,
manufacturing sites and marketing subsidiaries, we strive to realise
our hhc philosophy by delivering innovative products in multiple
therapeutic areas with high unmet medical needs, including Oncology
and Neurology.

As a global pharmaceutical company, our mission extends to
patients around the world through our investment and participation in
partnership-based initiatives to improve access to medicines in
developing and emerging countries.

For more information about Eisai Co., Ltd., please visit
http://www.eisai.com.

References

1. European Commission Implementing Decision for Halaven received
June 2014

2. Women's Health Empowerment Program Moscow and Central Russia.
www.hsph.harvard.edu/breastandhealth/files/ekaterina_bashta.pdf [htt
p://www.hsph.harvard.edu/breastandhealth/files/ekaterina_bashta.pdf ]
. Last accessed December 2014

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. Kaufman P, Awada A, Twelves C et al. A Phase III, open-label,
randomised, multicenter study of eribulin mesylate versus
capecitabine in patients with locally advanced or metastatic breast
cancer previously treated with anthracyclines and taxanes. Presented
at 2012 CTRC-AACR San Antonio Breast Cancer Symposium

5. Data on File. ERI-099 Improvement in Overall Survival in
Metastatic Breast Cancer

Date of preparation: December 2014

Job code: Halaven-UK0380

ots Originaltext: Eisai Europe Limited
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