Lancet Publishes First Trial To Show Overall Survival Benefit Of Halaven® (eribulin) in People With Soft Tissue Sarcoma Sub-Types

Hatfield, England (ots/PRNewswire) -

An application to extend the indication of eribulin for the
treatment of patients with unresectable locally advanced soft tissue
sarcoma subtypes has been submitted in the EU

Full results of study 309 published for the first time in The
Lancet show Halaven® (eribulin) improved median overall survival
compared to dacarbazine for people with unresectable locally advanced
liposarcomas and leiomyosarcomas,[1] two of the most common forms of
soft-tissue sarcoma.[2] In addition to the full results, The Lancet
has also published an editorial in which the results of the study are
discussed.[3]

"This is the first data of a single agent therapy to show such a
benefit. The fact that these results have been published in such a
prestigious clinical journal, shows their importance in this area of
unmet need," commented Patrick Schöffski, Head of the Department of
General Medical Oncology, University Hospitals Leuven, Belgium.

Study 309 included data from 452 people (aged 18 and over) with
leiomyosarcomas or liposarcomas to compare the efficacy and safety of
eribulin to dacarbazine.[1] Leiomyosarcomas and liposarcomas make up
around 30% of all cases of soft tissue sarcomas[2] and develop from
cells in the tissues that surround the body such as fat, muscle,
nerves, fibrous tissues and blood.[4] Leiomyosarcomas form from cells
called smooth muscle and can start anywhere in the body,[4] while
liposarcomas (adipocytic sarcomas) originate in fat cells and can
also occur anywhere in the body.[4]

"We are proud to see these data published in The Lancet and will
continue to develop compounds that make a positive difference to the
lives of people with cancer and their loved ones. We are delighted
that eribulin has been licensed in the US in this important soft
tissue sarcoma subtype", comments Gary Hendler, President, Eisai
Global Oncology Business Unit and President & CEO Eisai EMEA.

In July a Type II variation application to extend the indication
of eribulin was submitted in the European Union for the treatment of
patients with unresectable soft tissue sarcoma who have received
prior chemotherapy for locally advanced disease. In the US, the Food
and Drug Administration (FDA) approval was granted on January 28 2016
for eribulin in the treatment of patients with unresectable
liposarcoma who have received a prior anthracycline containing
regimen. A similar application was submitted in Japan.

Though soft tissue sarcomas are relatively rare, they carry a poor
prognosis, with many people unresponsive to treatment.[5] In Europe,
approximately 29,000 people are diagnosed with soft tissue sarcomas
each year.[6] Approximately 11,930 cases of soft tissue sarcomas will
have been diagnosed in the United States this year.[7] In Japan,
approximately 2,000 cases of soft tissue sarcomas are diagnosed each
year.[8],[9]

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.

Eribulin is currently 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.[10]

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.[11]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.[5]

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.[1]

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. Cancer Research UK, Soft Tissue Sarcoma Incidence Statistics.
Available at: http://www.cancerresearchuk.org/cancer-info/cancers
tats/types/soft-tissue-sarcoma/incidence/ Accessed: November 2015
3. Young R, Woll P. Eribulin - a new active agent for L-sarcoma. The
Lancet. 2016
4. Macmillan. What are soft tissue sarcomas? Available at: htt
p://www.macmillan.org.uk/Cancerinformation/Cancertypes/Softtissue
sarcomas/Aboutsofttissuesarcomas/Softtissuesarcomas.aspx.
Accessed: November 2015
5. Fletcher et al. World Health Organization Classification of
Tumours of Soft Tissue and Bone (4th Edition). Lyon: IARC Press,
2013
6. ESMO Guidance. Available at: http://annonc.oxfordjournals.org/con
tent/25/suppl_3/iii102.full.pdf+html Accessed: November 2015
7. National Cancer Institute. Available at: http://www.cancer.gov/ca
ncertopics/pdq/treatment/adult-soft-tissue-sarcoma/HealthProfessi
onal/page1. Accessed November 2015
8. Matsuda S., et al. Soft-Tissue Sarcoma Surveillance Counterpoint:
Japan. Current Clinical Oncology. 2013; 233-34
9. Tsujii H, et al. Carbon-Ion Radiotherapy: Principles, Practices,
and Treatment Planning. Springer. 2014; (XII)312:37
10. SPC Halaven (updated November 2015). Available at:
http://www.medicines.org.uk/emc/medicine/24382 Accessed: December
2015
11. R. Pollock. Soft Tissue Sarcomas, A Volume in the American Cancer
Society Atlas of Clinical Oncology Series. 2012

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