New Data for Eisai's Halaven® (eribulin) and Lenvima® (lenvatinib) in Hard to Treat Cancers will be Presented at Forthcoming American Society of Clinical Oncology (ASCO) Meeting

Hatfield, England (ots/PRNewswire) -

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

ASCO invites six abstracts on new Halaven® (eribulin) data in
liposarcoma and solid tumours, and new lenvatinib data in thyroid
cancers and in renal cell carcinoma

Six abstracts that feature new study results in hard to treat
cancers for Eisai's treatments eribulin and lenvatinib will be
presented during the 52nd Annual Meeting of the American Society of
Clinical Oncology (ASCO), Chicago, 3-7 June 2016. These data provide
new clinical evidence on the efficacy and safety of these two agents
in a variety of cancers.

New lenvatinib data in thyroid cancer and renal cell cancer

New efficacy data with a focus on duration of response from the
SELECT study[1] show improved duration of response to lenvatinib for
patients with radioiodine-refractory differentiated thyroid cancer
compared with placebo. Updated results show that 157 patients (60.2%)
respond to lenvatinib and the median duration of response is 30
months (95% CI 18.4-35.2), compared with three patients (2.3%) with
placebo and a median duration of response of 14.7 months (95% CI
7.5-not evaluable). Median duration of overall response is similar
by subgroup, except for patients with greater disease burden and
those with liver metastasis.

The final results of a single-arm open-label Phase II study[2] of
lenvatinib in 51 patients with differentiated, medullary and
anaplastic thyroid cancer show tumour shrinkage in almost all
patients, and with manageable toxicities.

In a subgroup analysis of a Phase II study in renal cell carcinoma
progression free survival benefit is maintained in high risk poor
prognosis renal cancer subgroups[2] (MSKCC risk, baseline tumour
size, metastasis site). Updated overall survival in the
intent-to-treat population shows a trend towards improved overall
survival for lenvatinib plus everolimus compared with everolimus.

New eribulin data in soft tissue sarcoma and in solid tumours

Significant benefit in overall survival is observed for eribulin
compared with dacarbazine in patients with liposarcoma according to a
subtype-specific analysis[3] of a Phase III study.[4] The Phase III
study included patients with leiomyosarcomas or liposarcomas and
results for both tumour types are published in the Lancet.[4]

In an exploratory analysis evaluating the quality of life at
progression in the same Phase III study[5], there were notable
increases in severity of symptoms among patients treated with
dacarbazine compared with eribulin.

A phase I study shows that a liposomal formulation of eribulin is
well tolerated and has promising activity in patients with solid
tumours.[5]

"The results being presented at ASCO underscore Eisai's ongoing
commitment to support patients with difficult to treat cancers for
which there are currently too few treatment options. As part of our
human health care mission we are committed to investing in innovative
therapies that have the potential to improve the lives of patients
and their families and deliver meaningful progress in the battle
against cancer," said Kenichi Nomoto, Ph.D., Chief Scientific Officer
of the Oncology Business Group, Eisai.

The full details of the six abstracts are as follows:

Presentation
Product Abstract Name
Details

Lenvatinib Phase II study of lenvatinib in
patients Poster
Abstract No: with differentiated, medullary,
and Presentation:
6088 anaplastic thyroid
cancer: final analysis Head and Neck
results
Cancer
Takahashi S,
et al Date: 4 June

Time: 1:00-4:30 PM
Lenvatinib
Duration of response to lenvatinib Poster
Abstract No:
treatment in patients with Presentation:
6089
radioiodine-refractory differentiated Head and Neck

thyroid cancer (RR-DTC) Cancer

Gianoukakis A, et al Date: 4 June

Time:
1:00-4:30 PM
Lenvatinib Subgroup analyses from the phase 2
trial Poster
Abstract No: of lenvatinib (LEN), everolimus
(EVE), Presentation:
4553 and LEN+EVE in metastatic
renal cell Genitourinary
carcinoma (mRCC)
(Non-prostate)
Hutson T, et
al Cancer

Date: 6 June

Time: 1:00-4:30 PM
Eribulin
Phase 1 multicenter, open label study to Poster
Abstract No:
establish the maximum tolerated dose Presentation:
2524
(MTD) of two administration schedules of Developmental

E7389 (eribulin) liposomal formulation in
Therapeutics-Clini
patients (pts) with solid
tumours cal Pharmacology
Zubairi I, et al
and Experimental

Therapeutics

Date: 5 June

Time: 8:00-11:30 AM

Eribulin Subtype specific activity in liposarcoma Poster

Abstract No: (LPS) patients (pts) from a phase 3, open
Presentation:
11037 label, randomised study of eribulin
(ERI) Sarcoma
versus dacarbazine (DTIC) in
patients Date: 6 June
with advanced LPS and
leiomyosarcoma(LMS) Time:8:00-11:30 AM
Chawla S,
et al
Eribulin
Evaluation of quality of life at Poster
Abstract No:
progression in patients with soft tissue Presentation:
11015
sarcoma Sarcoma

Hudgens S, et al Date: 6 June

Time: 8:00-11.30
AM

Eribulin is indicated in Europe 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
unless patients were not suitable for these treatments.[6]

The European Commission has recently approved a variation to the
terms of the Marketing Authorisation 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.

Lenvatinib is indicated in Europe for the treatment of adult
patients with progressive locally advanced or metastatic,
differentiated (papillary, follicular, Hürthle cell) thyroid
carcinoma (DTC) refractory to radioactive iodine (RAI).[7]

Notes to Editors

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.

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.[6]

Lenvatinib (E7080)

Lenvatinib simultaneously inhibits VEGFR, FGFR and also RET which
are especially involved in tumour angiogenesis and proliferation of
thyroid cancer. [8],[9] This potentially makes lenvatinib the first
TKI that simultaneously inhibits the kinase activities of FGFR 1-4 as
well as VEGFR 1-3.

Lenvatinib has been approved for the treatment of refractory
thyroid cancer in the United States and Japan, and has been submitted
for regulatory approval in Europe, Switzerland, South Korea, Canada,
Singapore, Russia, Australia and Brazil. Lenvatinib was granted
Orphan Drug Designation in Japan for thyroid cancer, in the United
States for treatment of follicular, medullary, anaplastic, and
metastatic or locally advanced papillary thyroid cancer and in Europe
for follicular and papillary thyroid cancer.

About SELECT[10],[11]

The SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer
of the Thyroid) study is a multicentre, randomised, double-blind,
placebo-controlled Phase III study to compare the PFS of patients
with RR- radioiodine-refractory differentiated thyroid cancer and
radiographic evidence of disease progression within the prior 13
months, treated with once-daily, oral lenvatinib (24mg) versus
placebo. The study enrolled 392 patients in over 100 sites in Europe,
North and South America and Asia and was conducted by Eisai in
collaboration with the SFJ Pharmaceuticals Group.

About soft tissue sarcomas

Leiomyosarcomas are one of the more common types of sarcoma to
develop in adults. They develop from cells called smooth muscle and
can start anywhere in the body. [12] Liposarcomas arise from fat
cells and can also occur anywhere in the body. Leiomyosarcomas and
liposarcomas make up approximately 30% of all cases of soft tissue
sarcomas.[12]

About thyroid cancer

Thyroid cancer forms in the tissues of the thyroid gland, located
at the base of the throat near the trachea.[13] Thyroid cancer
affects more than 52,000 people in Europe each year.[14]

About renal cell carcinoma

RCC accounts for approximately 90% of all kidney malignancies and
represents an estimated 2-3% of all cancer cases, with the highest
incidence occurring in Western countries.[15]

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. Gianoukakis A, et al. Duration of response to lenvatinib
treatment in patients with radioiodine-refractory differentiated
thyroid cancer (RR-DTC). American Society for Clinical Oncology
annual meeting 2016; Abstract # 6089

2. Hutson T, et al. Subgroup analyses from the phase 2 trial
of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in metastatic
renal cell carcinoma (mRCC). American Society for Clinical Oncology
annual meeting 2016; Abstract # 4553

3. Chawla S, et al. Subtype specific activity in liposarcoma
(LPS) patients (pts) from a phase 3, open label, randomised study of
eribulin (ERI) versus dacarbazine (DTIC) in patients with advanced
LPS and leiomyosarcoma (LMS). American Society for Clinical Oncology
annual meeting 2016; Abstract # 11037

4. 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; DOI:
http://dx.doi.org/10.1016/S0140-6736(15)01283-0

5. Zubairi I, et al. Phase 1 multicenter, open label study to
establish the maximum tolerated dose (MTD) of two administration
schedules of E7389 (eribulin) liposomal formulation in patients (pts)
with solid tumours. American Society for Clinical Oncology annual
meeting 2016; Abstract # 2524

6. SPC eribulin (updated March 2016). Available at:
http://www.medicines.org.uk/emc/medicine/24382 . Last accessed April
2016

7. SPC lenvatinib (updated June 2015). Available at:
http://www.medicines.org.uk/emc/medicine/30412 . Last accessed April
2016

8. Matsui J, et al. Multi-kinase inhibitor E7080 suppresses
lymph node and lung metastases of human mammary breast tumor
MDA-MB-231 via inhibition of vascular endothelial growth factor
receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res
2008;14:5459-65

9. Matsui J, et al. E7080, a novel inhibitor that targets
multiple kinases, has potent antitumor activities against stem cell
factor producing human small cell lung cancer H146, based on
angiogenesis inhibition. Int J Cancer 2008;122:664-671

10. Schlumberger M, et al. Lenvatinib versus placebo in
radioiodine refractory differentiated thyroid cancer. NEJM
2015;372:621-30

11. Schlumberger M, et al. A phase 3, multicenter,
double-blind, placebo-controlled trial of lenvatinib (E7080) in
patients with 131I-refractory differentiated thyroid cancer (SELECT).
ASCO 2014 abstract #LBA6008

12. Cancer Research UK, Soft Tissue Sarcoma Incidence
Statistics: http://www.cancerresearchuk.org/cancer-info/cancerstats/t
ypes/soft-tissue-sarcoma/incidence/ Last accessed May 2015

13. National Cancer Institute at the National Institute of
Health. Available at: http://www.cancer.gov/cancertopics/pdq/treatmen
t/thyroid/Patient/page1/AllPages#1 Accessed: April 2016

14. EUCAN 2015.
http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=35. Accessed: April
2016

15. Ljungberg B, et al. Guidelines on Renal Cell Carcinoma.
Available at: http://uroweb.org/wp-content/uploads/10-Renal-Cell-Carc
inoma_LR-LV2-2015.pdf . Last accessed April 2016

ots Originaltext: Eisai
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