European Commission Approves Halaven® (Eribulin) for Treatment of Advanced Liposarcoma in Europe

Hatfield, England (ots/PRNewswire) -

FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN MEDIA

Eribulin is the first and only single agent to show a significant
improvement in overall survival for people with advanced liposarcomas

People with advanced liposarcomas in Europe may now be able to
receive Halaven® (eribulin), the first and only single agent therapy
to show a significant survival advantage in this type of soft tissue
sarcoma.[1] The European Commission has approved a variation to the
terms of the Marketing Authorisation (MA) of eribulin for the
treatment of adult patients with unresectable liposarcomas who have
received prior anthracycline containing therapy (unless unsuitable)
for advanced or metastatic disease.

The decision is based on the results of Study 309 which is now
published in The Lancet. This is a randomised, open-label multicentre
Phase III study comparing the efficacy and safety of eribulin
mesilate to dacarbazine in 452 patients (aged 18 or over) with
leiomyosarcomas or liposarcomas.[1] Data show a median overall
survival improvement of 2.6 months (13.5 months versus 11.5 months)
in patients with leiomyosarcomas or liposarcomas treated with
eribulin versus dacarbazine (HR=0.768, 95% CI 0.618-0.954;
P=0.017).[1] A subset of people with unresectable advanced or
metastatic liposarcomas treated with eribulin lived a median 7.2
months longer than those treated with dacarbazine (15.6 months versus
8.4 months median OS, HR = 0.511; 95% CI 0.346-0.753; P=0.0006).[1]
Eribulin's toxicity profile was consistent with prior experience,
with no unexpected or new safety findings.[1]

"This decision marks an important milestone for people in Europe
with advanced liposarcomas. There are currently limited treatment
options available, but now, we are a step closer to being able to
offer them a treatment with a proven overall survival benefit.
Eribulin was the first-ever single agent therapy to show such a
survival benefit, which makes today's news all the more important for
patients and clinicians across Europe," comments Patrick Schöffski,
University Hospitals Leuven, Belgium.

Eribulin is a microtubule-dynamics inhibitor, structurally
modified analogue of halichondrin B, originally isolated from the
marine sponge Halichondria okadai. Its mode of action is distinct
from other tubulin inhibitors and involves binding to specific sites
on the growing positive ends of microtubules to inhibit their growth.
Recent data for blood perfusion show that eribulin may lead to
remodelling of the tumour vasculature, resulting in an oxygenated
environment.[2] Cancer cells thrive in a deoxygenated (hypoxic)
environment and therefore improving tumour perfusion may lead to a
decrease in tumour metastatic potency.[3]

Only 50% of people with soft tissue sarcomas are expected to live
for five years.[4] 29,000 people are diagnosed with soft tissue
sarcomas each year, approximately 1% of all cancers diagnosed in
Europe.[5] Liposarcomas (adipocytic sarcomas) originate in fat cells
and can occur anywhere in the body.[6]

Eribulin is also indicated for the treatment of women 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.[7]

"At Eisai, our first thought is with people in Europe who now have
access to this new treatment and the benefit it may have for them and
their families. This is the second form of cancer in which eribulin
has demonstrated an overall survival benefit when compared to active
therapy. We are encouraged by the Commission's decision, and will
continue with our commitment to develop and discover products that
have a positive impact on patients and their families," comments Gary
Hendler, Chief Commercial Officer Oncology Business Group, Chairman
and CEO EMEA.

In January 2016 the Food and Drug Administration (FDA) approved
eribulin for the treatment of people in the US with unresectable or
metastatic liposarcoma who have received a prior
anthracycline-containing regimen. License was granted in Japan to
extend the indication of eribulin to treat patients with soft tissue
sarcomas in February 2016.

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.

Notes to Editors

Halaven® (eribulin)

Eribulin is the first in the halichondrin class of microtubule
dynamics inhibitors with a novel mechanism of action. Structurally
eribulin is a simplified and synthetically produced version of
halichondrin B, a natural product isolated from the marine sponge
Halichondria okadai. Eribulin is believed to work by inhibiting the
growth phase of microtubule dynamics which prevents cell division.

About Soft Tissue Sarcomas

Soft tissue sarcoma is a collective term for a diverse group of
malignant tumours.

Unlike other cancers such as non-small cell lung cancer (NSCLC),
soft tissue sarcomas are mostly diagnosed with localised disease, and
many are amenable to complete surgical removal, yet relapse rates can
be as high as 50 percent.[8] Outcomes for patients with advanced
disease are poor, with median survival around one year or less. Due
to the rarity of these tumours, evidence for prognostic factors is
weak and not well understood.[9]

Global Phase III Clinical Study 309[1]

The primary endpoint of the study was to compare overall survival
between patients treated with eribulin mesilate (1.4 mg/m²
intravenously on days 1 and 8) and those treated with dacarbazine
(850 mg/m², 1000 mg/m², or 1200 mg/m² [dose dependent on centre and
clinician] intravenously on day 1). The additional endpoints included
progression free survival and quality of life.

Patients were aged >=18 years with advanced high/intermediate
grade leiomyosarcoma or dedifferentiated, myxoid, round cell or
pleomorphic variants of adipocytic sarcoma (ADI) incurable by surgery
and/or radiotherapy were enrolled. Patients had ECOG status <=2 and
had received >=2 standard systemic treatment regimens including an
anthracycline. Patients were randomized 1:1 to eribulin mesilate (1.4
mg/m2, IV on D1 and D8) or dacarbazine (850-1200 mg/m2, IV on D1)
every 21 days until disease progression.

Overall, 452 patients (67% female; 79% <65 years) were randomized
(228 eribulin; 224 dacarbazine). Median OS for eribulin and
dacarbazine was 13.5 and 11.5 months, respectively (HR=0.768, 95% CI
0.618-0.954; P=0.017). PFS was 2.6 months in both arms (HR=0.877, 95%
CI 0.710-1.085; P=0.229). PFS rate at week 12 was 33% and 29% for
eribulin and dacarbazine, respectively. Eribulin had a toxicity
profile consistent with prior experience, with no unexpected or new
safety findings. In this study, the most common adverse events
observed in the eribulin arm were neutropenia, fatigue, nausea,
alopecia and constipation, which is consistent with the known profile
of eribulin.

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. Schöffski P et al. Eribulin versus dacarbazine in previously
treated patients with advanced liposarcoma or leiomyosarcoma: a
randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016

2. Kawano S, et al. Antimitotic and Non-mitotic Effects of
Eribulin Mesilate in Soft Tissue Sarcoma. Anticancer Research 2016;
36; 1553-1562

3. Kevin L Bennewith and Shoukat Dedhar. Targeting hypoxic tumour
cells to overcome metastasis. BMC Cancer 2011;11:504

4. National Cancer Institute - http://www.cancer.org/cancer/sarcom
a-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cance
r-survival-rates

5. ESMO Guidance. Available at: http://annonc.oxfordjournals.org/c
ontent/25/suppl_3/iii102.full.pdf+html Accessed: May 2016

6. Macmillan. What are soft tissue sarcomas? Available at: http:/
/www.macmillan.org.uk/Cancerinformation/Cancertypes/Softtissuesarcoma
s/Aboutsofttissuesarcomas/Softtissuesarcomas.aspx . Accessed: May
2016

7. SPC Halaven (updated November 2015). Available at:
http://www.medicines.org.uk/emc/medicine/24382 Accessed: May 2016

8. R Pollock. Soft Tissue Sarcomas, A Volume in the American
Cancer Society Atlas of Clinical Oncology Series. 2012

9. Fletcher, et al. World Health Organization Classification of
Tumours of Soft Tissue and Bone (4th Edition). Lyon: IARC Press, 2013

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