New Data for Halaven® (eribulin) at SABCS 2016 Demonstrate Continued Potential in Treatment of Multiple Types of Locally Advanced or Metastatic Breast Cancer

Hatfield, England (ots/PRNewswire) -

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/US JOURNALISTS

Eisai highlights 17 new data abstracts for eribulin in metastatic
breast cancer at the San Antonio Breast Cancer Symposium (SABCS), San
Antonio, USA, 6-10 December.

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 unless patients were not suitable for these treatments.[1]

"Eribulin has previously demonstrated a clinically meaningful
overall survival benefit in two pivotal studies in advanced breast
cancer and advanced sarcoma. Eisai remains fully committed to
continue developing eribulin and we look forward to the presentation
of these results at the SABCS," comments Gary Hendler Chief
Commercial Officer, Global Oncology Business Group and Chairman & CEO
EMEA.

The continued development of its oncology portfolio underscores
Eisai's human health care (hhc) mission, the company's commitment to
innovative solutions in disease prevention, cure and care for the
health and wellbeing of people worldwide. Eisai is committed to the
therapeutic area of oncology and to address the unmet medical needs
of people with cancer and their families.

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Abstract Name

A phase II, open-label, multicentre, translational study for
biomarkers of eribulin mesylate: evaluation of the utility of
monitoring epithelial-to-mesenchymal transition (emt) markers on
tumour cells in the malignant plural effusion of patients with
metastatic breast cancer (expect-study)

Watanabe et al

Poster: OT1-01-01

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name

PAINTER: Evaluation of eribulin tolerability and correlation
between a set of polymorphisms and neuropathy in patients with
metastatic breast cancer

La Verde et al

Poster: OT1-01-05

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name

PIQHASSO: Open label, non-randomised, multicentre phase I/IIb
study investigating safety and efficacy of PQR309 and eribulin
combination in patients (pts) with locally advanced (LA) or
metastatic HER2 (-) and triple-negative breast cancer (TNBC) (study
PQR309-007)

López et al

Poster: OT1-01-06

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

A phase II study of eribulin followed by doxorubicin and
cyclophosphamide as preoperative therapy for HER2-negative
inflammatory breast cancer

Overmoyer et al

Poster: OT1-01-07

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

A phase II, multicentre, randomised trial of eribulin plus
gemcitabine (EG) vs. paclitaxel plus gemcitabine (PG) in patients
with HER2-negative metastatic breast cancer as first-line
chemotherapy

Park et al

Poster: OT1-01-12

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

Efficacy and gene expression results from SOLTI1007 NEOERIBULIN
phase II clinical trial in HER2-negative early breast cancer

Prat et al

Poster: P1-09-09

Session Title: Prognostic and Predictive Factors: Response
Predictive Factors - Clinical Testing and Validation

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

A randomized, open-label, multicentre, phase Ib/II study of
eribulin mesylate in combination with PEGylated recombinant human
hyaluronidase in patients with human epidermal growth factor receptor
2-negative, high-hyaluronan metastatic breast cancer

Alvarez et al

Poster: OT2-02-02

Session Title: New Approaches and Agents

Session Date: 8/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

Eribulin induces vascular remodelling and reoxygenation in
advanced breast cancer patients: A comparative study with bevacizumab

Ueda et al

Poster: P4-02-01

Session Title: Detection/Diagnosis: Breast Imaging - Other Methods

Session Date: 9/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

----

Abstract Name

Eribulin impairs TGF? type I receptor localization and signaling
in BT549 cells

Kaul et al

Poster: P4-04-04

Session Title: Tumour Cell and Molecular Biology:
Epithelial-Mesenchymal Transition

Session Date: 9/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

----

Abstract Name

Phase Ib/II study to evaluate eribulin mesylate in combination
with pembrolizumab in patients with metastatic triple-negative breast
cancer

Tolaney et al

Poster: P5-15-02

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

A phase II study of eribulin as early-line treatment for HER2-
MBC: Evaluation of efficacy, toxicity, and patient-reported outcomes

Metzger et al

Poster: P5-15-08

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

Eribulin mesylate (eribulin) showed inhibitory effects on
epithelial-mesenchymal transition (EMT) in tumours of metastatic
breast cancer patients. First preliminary report of a prospective
study

Utsumi et al

Poster: P5-15-10

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

Eribulin should be a candidate strategy in combination with
pertuzumab plus trastuzumab for taxane pretreated HER2 positive
advance breast cancer

Araki et al

Poster: P5-15-11

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

Utilization and outcomes of eribulin in triple negative metastatic
breast cancer: real-world findings

Kish et al

Poster: P5-15-16

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

----

Abstract Name

High reduction of circulating tumour cells in HER2-negative
locally advanced or metastatic breast cancer (LAMBC) patients treated
with eribulin as third line chemotherapy (ONSITE study)

Manso et al

Poster: P6-07-21

Session Title: Tumour Cell and Molecular Biology: Biomarkers

Session Date: 10/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

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Abstract Name

CASCADE study: Rapid survival decline per treatment line in
metastatic breast cancer

García et al

Poster: P6-09-33

Session Title: Prognostic and Predictive Factors: Prognostic and
Predictive Factors - Other

Session Date: 10/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

----

Abstract Name

Efficacy results of a phase 1/2 study of glucocorticoid receptor
(GR) antagonist mifepristone (MIFE) in combination with eribulin in
GR-positive triple-negative breast cancer (TNBC)

Han et al

Poster: P6-12-15

Session Title: Treatment: New Drugs and Treatment Strategies

Session Date: 10/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

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Notes to Editors

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.[2] At this advanced stage, the cancer spreads beyond the
breast to other parts of the body.

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.

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.

Eisai in Oncology

Eisai is committed to the development and delivery of highly
beneficial new treatments for people with cancer. The development of
therapeutic options in oncology is a major strategic area for Eisai
in Europe, the Middle East, Africa, Russia and Oceania (EMEA). In the
European Union, Eisai currently has three marketed treatments across
four indications:

- Lenvima® (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).
- Kisplyx® (lenvatinib) is indicated in the European Union 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.
- Halaven® (eribulin) is indicated for the treatment of adult
patients with locally advanced or metastatic breast cancer who have
received 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. Halaven®
(eribulin) is also indicated for the treatment of adult patients
with unresectable liposarcomas who have received prior
anthracycline containing therapy (unless unsuitable) for advanced
or metastatic disease.

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. EMA, Halaven. Available at: http://www.ema.europa.eu/ema/in
dex.jsp?curl=pages/medicines/human/medicines/002084/smops/Positive/hu
man_smop_000955.jsp&mid=WC0b01ac058001d127. Accessed November 2016

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

November 2016

Eribulin-EU0208

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

Contact:
Eisai
Cressida Robson / Chloe Fox
+44 7908 314 155/+44 7508 355 171
Cressida_Robson@eisai.net
Chloe_Fox@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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