EISAI to Unveil New Data on Halaven® (Eribulin) Mode of Action at San Antonio Breast Cancer Symposium 2015 (SABCS)

Hatfield, England (ots/PRNewswire) -

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/U.S.
JOURNALISTS

Studies at the upcoming San Antonio Breast Cancer Symposium
(Texas, 8-11 December) will explore mode of action and highlight
potential new combinations

New data at the San Antonio Breast Cancer Symposium (SABCS) will
explore the distinct mode of action of Halaven® (eribulin) in which
the epithelial-to-mesenchymal transition is reversed, the process by
which cancerous cells are made more aggressive and harder to treat.
The full results of the study, called "Eribulin affects E-cadherin
localization consistent with a reversal of the
epithelial-to-mesenchymal transition" will be presented as a poster
(P5-03-09) at the conference on Friday 11 December (17:00-19:00 CST).

Eisai will present a total of seventeen eribulin abstracts at
SABCS. Eribulin is currently indicated in Europe for the treatment of
adult patients 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]

A further study of stage I-II Hormone receptor positive/Her2
negative breast cancer to be presented at SABCS has data suggesting
that women with the aggressive, Luminal B form of the disease might
benefit the most from treatment on eribulin which induces a luminal A
phenotype. The study, "Efficacy and gene expression results from
eribulin SOLTI1007 neoadjuvant study (https://clinicaltrials.gov/ct2
/show/NCT01669252?term=SOLTI1007+neoadjuvant+study+eribulin&rank=1)",
will be presented as a poster (P3-07-66) at the conference on
Thursday 10 December (17:00 - 19:00 CST).

A number of other studies to be presented at SABCS will also
highlight the potential of eribulin to work in combination with other
therapies. One study will present the design of a phase 1b/2 study to
evaluate the efficacy and safety of eribulin in combination with
pembrolizumab in patients with metastatic triple-negative breast
cancer. A second study will explore whether PH20 (PEGPH20) (Pegylated
Recombinant Human Hyaluronidase) enhances efficacy of eribulin in
triple negative breast cancer xenografts.

The full details of the seventeen eribulin abstracts are as
follows:

Abstract Number Abstract Name
Presentation Details OT1-03-19 Design of a Phase 1b/2
Study to Poster Session: OT1-03-19 Evaluate
the Efficacy and Safety of Date: Wednesday, December 9
Eribulin Mesylate in Combination with Time: 5:00 PM-7:00 PM
Pembrolizumab in Patients with Metastatic
Triple-Negative Breast Cancer
P3-07-39 CASCADE study: Treatment and clinical
Poster Session: P3-07-39 outcomes of metastatic breast
cancer by Date: Thursday, December 10 tumor
immunophenotypes Time: 5:00 PM-7:00 PM
OT3-02-11 Phase 2 Study Evaluating the Efficacy Poster
Session:OT3-02-11 and Safety of Eribulin Mesylate
Date: Friday, December 11
Administered Biweekly for Subjects With Time: 5:00 PM-7:00 PM
Human Epidermal Growth Factor Receptor
2-Negative Metastatic Breast Cancer P1-12-05 Phase 2 study
of dose-dense doxorubicin Poster Session: P1-12-05
and cyclophosphamide followed by Date: Wednesday, December 9
eribulin mesylate with or without Time: 5:00
PM-7:00 PM prophylactic growth factor for adjuvant
treatment of early-stage breast cancer P6-08-07
Association between phenotype of triple Poster Session: P6-08-07
negative breast cancer cell lines and Date: Saturday,
December 12 sensitivity against eribulin mesylate
Time: 7:30 AM-9:00 AM in vitro
P5-03-08 Eribulin impairs the transport of
Poster Session: P5-03-08 TGF-ss type I receptor
leading to Date: Friday, December 11 inhibition
of downstream non-canonical Time: 5:00 PM-7:00 PM
TGFss signaling necessary for cancer metastasis and
survival P5-03-09 Eribulin affects E-cadherin
Poster Session: P5-03-09 localization
consistent with a reversal Date: Friday, December 11
of the epithelial-to-mesenchymal Time: 5:00 PM-7:00 PM
transition P1-14-04 A
Randomized Phase II Neoadjuvant Study Poster Session: P1-14-04
of Sequential Eribulin Followed by Date: Wednesday,
December 9 FAC-Regimen Compared to Sequential
Time: 5:00 PM-7:00 PM Paclitaxel Followed by
FAC/FEC-regimen in Women with Early Stage Breast
Cancer Not Overexpressing HER-2
P6-13-17 The combination of eribulin and Poster Session:
P6-13-17 everolimus results in enhanced
Date: Saturday, December 12 suppression of tumors in
mouse models Time: 7:30 AM-9:00 AM of triple
negative breast cancer P3-07-66 Efficacy and gene
expression results Poster Session: P3-07-66 from
eribulin SOLTI1007 neoadjuvant Date: Thursday, December 10
study Time: 5:00
PM-7:00 PM P1-12-04 A phase 2 study of eribulin in breast
Poster Session: P1-12-04 cancer not achieving a
pathologic Date: Wednesday, December 9 complete
response (pCR) to neoadjuvant Time: 5:00 PM-7:00 PM
chemotherapy (NAC) P1-14-06 A phase II
randomized study with Poster Session: P1-14-06
eribulin/cyclophosphamide (ErC) and Date: Wednesday, December 9
docetaxel/cyclophosphamide (TC) as Time: 5:00
PM-7:00 PM neoadjuvant therapy in HER2-negative
breast cancer- Final analysis of primary
endpoint and correlative analysis results
P6-13-21 Phase 1 study of GR antagonist
Poster Session: P6-13-21 mifepristone (M) in
combination with Date: Saturday, December 12
eribulin (E) in advanced solid tumors, Time: 7:30 AM-9:00 AM
with dose expansion in patients (pts) with
GR-positive triple-negative breast cancer (TNBC)
P1-03-09 Pegylated Recombinant Human
Poster Session: P1-03-09 Hyaluronidase PH20
(PEGPH20) Enhances Date: Wednesday, December 9
Efficacy of Eribulin Mesylate Time: 5:00 PM-7:00 PM
(HALAVEN(R)) in Triple Negative Breast Cancer
Xenografts
OT3-02-05 Phase II study of eribulin in Poster
Session: OT3-02-05 combination with gemcitabine for
the Date: Friday, December 11 treatment of
patients with locally Time: 5:00 PM-7:00 PM
advanced or metastatic triple negative breast cancer.
ERIGE Trial on behalf of the Gruppo Oncologico
Italiano di Ricerca Clinica (GOIRC)
P1-10-06 Nausea control and quality-of-life Poster
Session: P1-10-06 benefit with NEPA, the first
Date: Wednesday, December 9 combination antiemetic
agent, in Time: 5:00 PM-7:00 PM patients with
breast cancer receiving anthracycline/cyclophosphamide
(AC) chemotherapy

Some of the information discussed in this release is about
investigational uses for eribulin.

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

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.[1]

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. SPC Halaven (updated November 2015). Available at:
http://www.medicines.org.uk/emc/medicine/24382 . Last accessed
November 2015

Date of preparation: November 2015 Job code: Halaven-UK0452

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

Contact:
Eisai
Cressida Robson / Ben Speller
+44(0)7908 314 155 / +44(0) 7908 409416
Cressida_Robson@eisai.net
Ben_Speller@eisai.net

Tonic Life Communications: Alex Davies / Deepa Patel
+44 (0)7720 496 472 / +44 (0)7725 440 867
Alex.Davies@toniclc.com
Deepa.Patel@toniclc.com