New Data for Halaven® (eribulin), Lenvima® (lenvatinib) and Kisplyx® (lenvatinib) Demonstrate Continued Strength of Eisai Oncology Portfolio at ESMO 2016

Hatfield, England (ots/PRNewswire) -

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

Eisai highlights seven new data abstracts in hard to treat cancers
for eribulin and lenvatinib at the European Society for Medical
Oncology (ESMO) Congress, Copenhagen, 7-11 October 2016.

Lenvatinib data in thyroid cancer, renal cell carcinoma and other
solid tumours

An investigational phase II study for lenvatinib focuses on the
treatment of KIF5B-RET-positive adenocarcinoma of the lung.[1]
Adenocarcinoma is a type of non-small cell lung carcinoma, one of the
most common forms of lung cancer.[1] RET fusions activate RET kinase
and occur in 1-2% of patients.[1]

Exploratory early phase data will review lenvatinib with anti PD-1
therapy including a phase Ib study in people with selected solid
tumours.[2]

Subanalyses from the pivotal SELECT study investigate responses in
specific metastasis sites following treatment with lenvatinib for
patients with radioiodine-refractory (RAI-R) differentiated thyroid
cancer (DTC).[3] SELECT is a multicentre randomised, double-blind,
placebo-controlled phase III study to compare the progression-free
survival (PFS) of patients with radioiodine-refractory differentiated
thyroid cancer.[4]

A pre-clinical study examines the VEGFR and FGFR signalling
pathway participation in tumour growth and angiogenesis in human
renal cell carcinoma xenografts treated with the combination of
lenvatinib plus everolimus.[5] A further pre-clinical study analyses
immune response in syngeneic murine tumour models to understand the
antitumour effect and mechanism of action of the combination of
lenvatinib and PD-1 blockade treatment in a number of cancer
models.[6]

Epidemiological data in metastatic breast cancer

A study investigates the progressive decline in efficacy of active
agents in locally advanced or metastatic breast cancer with each
successive therapy cycle.[7] The study includes data from 443
patients in Spain with locally advanced or metastatic breast
cancer.[7]

Eribulin data in metastatic breast cancer

A study investigates the safety of eribulin in third-line
chemotherapy in 59 patients with HER2-negative metastatic or locally
advanced breast cancer.[8]

Exploratory data from the investigational, phase II, multicentre,
single arm trial (MERIBEL) will examine the efficacy and safety of
eribulin as a first-line therapy for HER2-metastatic breast
cancer.[9]

Eribulin data in soft tissue sarcomas

Results will be presented from a pre-specified subgroup analysis
in leiomyosarcomas of the phase III 309 study comparing eribulin to
dacarbazine.[10] Eribulin is not licensed in leiomyosarcomas in the
European Union.

"Eisai is committed to the development of innovative treatments
for people with cancer and always gives first thought to patients and
their families. Eribulin has demonstrated a unique overall survival
benefit compared to active comparators in advanced or metastatic
breast cancer and unresectable liposarcoma. Lenvatinib delivers
rapid, pronounced and durable responses and significantly prolongs
the time before a cancer progresses in both advanced thyroid and
advanced kidney cancer," comments Gary Hendler, Chairman & CEO EMEA
and Chief Commercial Officer, Global Oncology Business Group, Eisai.

Eisai Oncology Data at ESMO 2016

Lenvatinib

Poster: 1204PD

Abstract Name: Phase II study of lenvatinib in patients with RET
fusion-positive adenocarcinoma of the lung (Velcheti V et al)

Poster Discussion: NSCLC, metastatic

Date: 09 Oct 16

Time: 14:45-16:15

Room: Oslo

Poster: 776PD

Abstract Name: A phase Ib trial of lenvatinib plus pembrolizumab
in patients with selected solid tumours (Taylor M et al)

Poster Discussion: Genitourinary tumours, non-prostate

Date: 09 Oct 16

Time: 16:30-17:30

Room: Athens

Poster: 2PD

Abstract Name: Lenvatinib mesilate enhanced antitumour activity of
PD-1 blockade agent by potentiating Th1 immune response(Kato Y et al)

Poster Discussion: Basic science and translational research

Date: 09 Oct 16

Time: 16:30-17:30

Room: Berlin

Poster: 962P

Abstract Name: Responses in specific metastases following
treatment with lenvatinib: results from the phase III SELECT study
(Robinson B et al)

Poster Presentation: Poster display

Date: 09 Oct 16

Time: 13:00-14:00
Room: Hall E

Poster: 6P

Abstract Name: The antitumour activity of lenvatinib in
combination with everolimus in human RCC xenograft models is
dependent on VEGFR and FGFR signalling (Kimura T et al)

Presentation Details

Poster Presentation: Poster display

Date: 10 Oct 16

Time: 13:00-14:00
Room: Hall E

Epidemiological Data

Poster: 248P

Abstract Name: CASCADE study: pronounced decline in treatment
efficacy through the metastatic life of breast cancer patients (De
Paz L et al)

Poster Presentation: Poster display

Date: 10 Oct 16

Time: 13:00-14:00
Room: Hall E

Eribulin

Poster: 238P

Abstract Name: MERIBEL study: First-line eribulin for
taxane-resistant HER2[-] metastatic breast cancer (MBC) patients
(Ortega V et al)

Poster Presentation: Poster display

Date: 10 Oct 16

Time: 13:00-14:00
Room: Hall E

Poster: 246P

Abstract Name: Single arm, multicentre, non-randomized open-label
trial to evaluate the safety of eribulin in third line chemotherapy
in patients with HER2-negative metastatic or locally advanced breast
cancer previously treated with anthracyclines and taxanes: Onsite
study (ONCOSUR 2012-02)(Manso L et al)

Poster Presentation: Poster display

Date: 10 Oct 16

Time: 13:00-14:00
Room: Hall E

Poster: 1401PD

Abstract Name: Subgroup analysis in leiomyosarcoma (LMS) patients
from a phase III, open-label, randomised study of eribulin versus
dacarbazine in patients with advanced liposarcoma (LPS) and LMS (Blay
J et al)

Poster Discussion: Sarcoma

Date: 10 Oct 16

Time: 11:00-12:00

Room: Brussels

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.

Notes to Editors

About Thyroid Cancer

Thyroid cancer forms in the tissues of the thyroid gland, located
at the base of the throat near the trachea.[11]Thyroid cancer affects
more than 52,000 people in Europe each year.[12]

About Renal Cell Carcinoma (RCC)

Kidney cancer is among the ten most frequently occurring cancers
in Western (countries) communities.[13] About 270,000 cases of kidney
cancer are diagnosed globally each year and 116,000 people die from
the disease.[13]Approximately 90% of all kidney cancers are renal
cell carcinomas (RCC).[13]

About Lenvatinib

Lenvatinib is an oral multikinase inhibitor of vascular
endothelial growth factor receptor 1-3, fibroblast growth factor
receptor 1-4, platelet-derived growth factor receptor-alpha, and RET
and KIT proto-oncogenes.[14],[15]

Lenvatinib is indicated in the European Union 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).[16]
Lenvatinib is approved for the treatment of refractory thyroid cancer
in the United States, Switzerland, the European Union, Canada,
Russia, Australia, South Korea, Israel, Singapore, Japan and Brazil.

In September 2016, the European Commission issued Marketing
Authorisation for lenvatinib in combination with everolimus for the
treatment of adult patients with advanced renal cell carcinoma (RCC)
following one prior vascular endothelial growth factor
(VEGF)-targeted therapy.

About SELECT[4]

SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of
the Thyroid) is a multicentre, randomised, double-blind,
placebo-controlled phase III study of patients with
radioiodine-refractory differentiated thyroid cancer, treated with
once-daily, oral lenvatinib (24mg). The study enrolled 392 patients
in over 100 sites in Europe, Americas, Asia, and Australia.

About Study 205[17]

Study 205 is a pivotal randomised phase II study that evaluated
153 people living with unresectable advanced renal cell carcinoma who
had progressed after one previous VEGF therapy.[17] Patients
experienced a median progression-free survival of 14.6 months when
treated with lenvatinib in combination with everolimus (n=51),
compared with 5.5 months for those who received everolimus alone
(n=50) (HR 0.40; 95% CI: 0.24-0.67; p=0.0005).[17] Updated median
overall survival in the study population was 25.5 months in the
lenvatinib plus everolimus group compared with 15.4 months in the
everolimus group (HR 0.59; 95% CI 0.36 - 0.97).[17]

For lenvatinib in combination with everolimus, the most common
any-grade treatment-emergent adverse events (TEAEs) reported in the
lenvatinib plus everolimus group were diarrhoea, decreased appetite
and fatigue.[17] The most common TEAEs of Grade 3 or higher were
diarrhoea, fatigue and hypertension.[17]

About Metastatic Breast Cancer

More than 300,000 women are diagnosed with breast cancer in Europe
every year and about one third subsequently develop metastatic
disease.[18] At this advanced stage, the cancer spreads beyond the
breast to other parts of the body.

About Soft Tissue Sarcomas

Soft tissue sarcomas is a collective term for a diverse group of
malignant tumours. Unlike other cancers, soft tissue sarcomas are
often diagnosed with localised disease, and many are amenable to
complete surgical removal, yet relapse rates can be as high as
50%.[19] Only 50% of people with soft tissue sarcomas are expected to
live up to five years.[20] Outcomes for patients with advanced
disease are poor, with median survival around one year or less.[21]

Leiomyosarcomas are one of the more common types of sarcoma to
develop in adults. They develop from smooth muscle cells and can
start anywhere in the body.[22] Liposarcomas arise from fat cells and
can occur anywhere in the body. Leiomyosarcomas and liposarcomas make
up approximately 30% of all cases of soft tissue sarcomas.[21]

About 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 that prevents cell division.

Eribulin is indicated in the European Union for the treatment of
adults 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.[23]

The European Commission approved in May 2016 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.

Global Phase III Clinical Study 309[24]

Study 309 is a randomised, open-label, multicentre phase III study
comparing the efficacy and safety of eribulin mesilate (1.4 mg/m[2],
IV on days 1 and 8) to dacarbazine (850-1200 mg/m[2], IV on day 1) in
a 21-day cycle. A total of 452 patients (aged 18 or over) with soft
tissue sarcomas were randomised. The primary endpoint of the study
was overall survival. Additional endpoints included progression-free
survival and quality of life.

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. Velcheti V, et al. Phase 2 study of lenvatinib (LN) in patients
(Pts) with RET fusion-positive adenocarcinoma of the lung. European
Society for Medical Oncology 2016; Poster: 1204PD

2. Taylor M, et al. A phase 1b trial of lenvatinib (LEN) plus
pembrolizumab (PEM) in patients with selected solid tumours. European
Society for Medical Oncology 2016; Poster: 776PD

3. Robinson B, et al. Responses in specific metastases following
treatment with lenvatinib (LN): results from the phase 3 SELECT
trial. European Society for Medical Oncology 2016; Poster: 962P

4. Schlumberger M, et al. Lenvatinib versus placebo in
radioiodine-refractory differentiated thyroid cancer. NEJM 2015; 372:
621-630. Available at
http://www.nejm.org/doi/full/10.1056/NEJMoa1406470 Accessed:
September 2016

5. Kimura T, et al. The antitumor activity of lenvatinib (LEN) in
combination with everolimus (EVE) in human renal cell carcinoma (RCC)
xenograft models is dependent on VEGFR and FGFR signalling. European
Society for Medical Oncology 2016; Poster: 6P

6. Kato Y, et al. Lenvatinib mesilate (LEN) enhanced antitumor
activity of a pd-1 blockade agent by potentiating th1 immune
response, European Society for Medical Oncology (ESMO) meeting 2016,
Poster: 2PD

7. De Paz L, et al. CASCADE study: Pronounced decline in treatment
efficacy through the metastatic life of breast cancer patients.
European Society for Medical Oncology (ESMO) meeting 2016, Poster:
248P

8. Manso L, et al. ONSITE study: Single arm, multicentre,
non-randomized open-label trial to evaluate the safety of eribulin in
third line chemotherapy in patients with HER2-negative metastatic or
locally advanced breast cancer previously treated with anthracyclines
and taxanes. European Society for Medical Oncology (ESMO) meeting
2016, Poster: 246P

9. Ortega V, et al. MERIBEL STUDY: Single-agent eribulin as
first-line therapy for taxane-resistant HER2[-] metastatic breast
cancer (MBC) patients (pts). European Society for Medical Oncology
(ESMO) meeting 2016,

Poster: 238P

10. Blay J, et l. Subgroup analysis of leiomyosarcoma (LMS)
patients (pts) from a phase 3, open-label, randomized study of
eribulin (ERI) versus dacarbazine (DTIC) in pts with advanced
liposarcoma (LPS) or LMS. European Society for Medical Oncology
(ESMO) meeting 2016, Poster: 1401PD

11. National Cancer Institute at the National Institute of Health.
Available at:http://www.cancer.gov/cancertopics/pdq/treatment/thyroid
/Patient/page1/AllPages#1 Accessed: September 2016

12. EUCAN 2015. Thyroid Cancer. Available at:
http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=35 Accessed
September 2016

13. Ljungberg B, et al. Epidemiology of Renal Cell Carcinoma.
European Association of Urology, 2011; 60; 615-621

14. 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

15. Okamoto K, et al. Distinct binding mode of multikinase
inhibitor lenvatinib revealed by biochemical characterization. ACS
Medicinal Chemistry Letter 2010

16. SPC Lenvima (updated June 2015). Available at:
http://www.medicines.org.uk/emc/medicine/30412 Accessed September
2016

17. SPC Kisplyx (updated September 2016). Available at:
http://www.medicines.org.uk/emc/medicine/32335 Accessed September
2016.

18. World Health Organisation. Atlas of Health in Europe. 2003.
World Health Organization, Regional Office of Europe, Copenhagen,
Denmark.

19. Pollock R. Soft tissue sarcomas, A volume in the American
Cancer Society Atlas of Clinical Oncology Series 2012

20. National Cancer Institute. Adult soft tissue cancer survival
rates.

Available at:http://www.cancer.org/cancer/sarcoma-adultsofttissuec
ancer/detailedguide/sarcoma-adult-soft-tissue-cancer-survival-rates
Accessed September 2016

21. George S, et al. Systemic treatment of metastatic soft tissue
sarcoma. Available at:http://hgp.gob.ec/index.html/uptodate/contents/
mobipreview.htm?40/11/41146/abstract/4 Accessed September 2016

22. Cancer Research UK, Soft tissue sarcoma incidence statistics.
Available at: http://www.cancerresearchuk.org/cancer-info/cancerstat
s/types/soft-tissue-sarcoma/incidence/ Accessed September 2016

23. SPC Halaven (updated August 2016). Available at:
http://www.medicines.org.uk/emc/medicine/24382 Accessed September
2016

24. 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

September 2016

Oncology-EU0042

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

Contact:
Eisai: Cressida Robson / Ben Speller
+44 7908 314 155 / +44 7908 409 416
Cressida_Robson@eisai.net / Ben_Speller@eisai.net

Tonic Life Communications: Alex Davies / Callum Haire
+44 7716 324 722 / +44 7867 429 637
Alex.Davies@toniclc.com / Callum.Haire@toniclc.com

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