Eisai Announces Preliminary Results of Phase III Study of Halaven® (Eribulin) in Locally Advanced or Metastatic Breast Cancer

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• Publié par: eisai-europe-limited
• Nombre de lectures: 184
• Langue: English

Extrait

Eisai Announces Preliminary Results of Phase

III Study of Halaven® (Eribulin) in Locally

Advanced or Metastatic Breast Cancer

PR Newswire

HATFIELD, England, July 10, 2012

HATFIELD,

England

,

July 10, 2012

/PRNewswire/ --

Eisai Europe Limited today announces preliminary results from a recently

completed Phase III study (Study 301) comparing Halaven

®

(eribulin) and

Xeloda

®

(capecitabine). The study enrolled women with locally advanced or

metastatic breast cancer in an earlier line of treatment than eribulin is

currently licensed for. Preliminary results showed that the trial did not meet

the pre-specified criteria for either of the co-primary endpoints of overall

survival (OS) and progression-free survival (PFS). However, the study did show

a trend towards improved OS for patients who received eribulin compared with

capecitabine, but the improvement was not statistically significant. No

difference was seen in PFS. Furthermore, safety was consistent with the known

profile of eribulin.

Eisai plans to conduct a detailed analysis of the clinical trial data including the

secondary endpoints and subgroups pre-specified in the study protocol and will

work with the regulatory authorities towards potential regulatory filings. Further

study results will be submitted for presentation at forthcoming international

medical meetings.

"With over 1,100 women with advanced breast cancer studied, this is one of the

largest studies ever conducted in this patient population. There are important

trends here that will need further analysis. Eisai remains committed to

evaluating the safety and efficacy of eribulin in patients living with locally

advanced or metastatic breast cancer. This continues to be an area of

significant unmet medical need in women with advanced disease", said Kenichi

Nomoto, President, Oncology Product Creation Unit at Eisai.

The global Phase III trial (Study 301), was an open-label, randomised, two-

parallel-arm, multicentre study of 1,102 women with locally advanced or

metastatic breast cancer previously treated with anthracyclines and taxanes

either in the (neo) adjuvant setting or for locally advanced or metastatic

disease. The study included patients who have had zero to two previous

chemotherapies for advanced disease. Patients who have previously received

capecitabine were excluded from the study. Patients were randomised at a

ratio of 1:1 to receive treatment with either eribulin 1.23mg/m

2

(administered

intravenously over two to five minutes on days 1 and 8, every 21 days) or

capecitabine 2.5g/m

2

(administered orally twice daily in two equal doses on days

1 to 14, every 21 days), the regulatory approved recommended doses.

[1,2]

Study 301 is the second large Phase III trial studying OS for eribulin compared

to a standard treatment. Data from the first study, EMBRACE, presented in

2010 evaluated the role of eribulin in a later stage population compared to

Treatment of Physician Choice (TPC).

[3]

Eribulin is the first and only single-agent therapy proven to significantly extend

overall survival after two prior lines of metastatic breast cancer therapy when

compared to other single-agent therapies.

[3]

Results from a pivotal Phase III

study (EMBRACE) demonstrated a statistically significant overall survival benefit

for patients treated with eribulin compared with a single-agent TPC. The

primary analysis, conducted when ~55.4% of deaths (eribulin [274], TPC [148])

had been observed, demonstrated a median OS for eribulin vs TPC of 13.1

months (95% CI: 11.8, 14.3) vs 10.6 months (95% CI: 9.3, 12.5), (

P

=0.041). The

updated overall survival analysis was consistent with the primary analysis.

[3]

Eribulin is currently indicated in

Europe

for the treatment of patients with locally

advanced or metastatic breast cancer who have previously received at least

two chemotherapeutic regimens. Prior therapy should have included an

anthracycline and a taxane unless patients were not suitable for these

treatments.

[1]

Eribulin received European Commission approval on

17 March 2011

based on

the results of the Phase III EMBRACE study. Eribulin is approved in the European

Union,

USA

,

Switzerland

,

Japan

, and

Singapore

. In

Europe

, eribulin is currently

commercially available in

Austria

,

Denmark

,

Estonia

,

France

,

Finland

,

Germany

,

Iceland

,

Ireland

,

Italy

,

Japan

,

Luxembourg

,

Netherlands

,

Norway

,

Poland

,

Sweden

,

Switzerland

, and the

United Kingdom

.

In addition to the preliminary Phase III data announcement, Eisai announces

that the French authorities has granted reimbursement for the use of eribulin in

heavily pretreated women with metastatic breast cancer, recognising the

innovative nature of the treatment and the clinical value it may offer women.

Eisai also announces that it is expanding its footing in the Israeli market with

the registration grant of eribulin.

Notes to Editors

Halaven

®

(eribulin)

Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the

treatment of patients with breast cancer who have previously received at least

two chemotherapeutic regimens for metastatic disease and whose prior

therapy should have included an anthracycline and a taxane.

[1]

Eribulin

belongs to a class of antineoplastic agents, the halichondrins, which are natural

products, isolated from the marine sponge Halichondria okadai. It is believed to

work by inhibiting the growth phase of microtubule dynamics without affecting

the shortening phase and sequesters tubulin into non-productive aggregates.

Metastatic Breast Cancer

Metastatic breast cancer is an advanced stage of the disease that occurs when

cancer spreads beyond the breast to other parts of the body. In

Europe

,

approximately 6% of breast cancers are metastatic at diagnosis with a five-

year survival rate of 21%.

[4]

Eisai in Oncology

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. 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

Eisai is one of the world's leading R&D-based pharmaceutical companies and

has defined its corporate mission as "giving first thought to patients and their

families and to increasing the benefits health care provides," which we call

human health care (hhc).

Eisai recently expanded their UK Hatfield facility

which now supports the company's growing European, Middle Eastern, African

and Russian (EMEA) business.

Eisai concentrates its R&D activities in three key areas:

Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain,

epilepsy, depression

Oncology including: anticancer therapies; tumour regression, tumour suppression,

antibodies, etc and supportive cancer therapies; pain relief, nausea

Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic

disease, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S.,

Asia

,

Europe

and its domestic home market of

Japan

, Eisai employs more than 11,000 people worldwide. In

Europe

, Eisai

undertakes sales and marketing operations in over 20 markets, including the

United Kingdom

,

France

,

Germany

,

Italy

,

Spain

,

Switzerland

,

Sweden

,

Ireland

,

Austria

,

Denmark

,

Finland

,

Norway

,

Portugal

,

Iceland

,

Czech Republic

,

Slovakia

,

the Netherlands

,

Belgium

,

Luxembourg

,

Middle East

and

Russia

.

For further information please visit our web site http://www.eisai.com

July 2012

/ Halaven-UK0012

References

1. Halaven (eribulin) SPC available from:

http://www.medicines.org.uk/EMC/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/

(Updated

May 2012

)

2. Xeloda (capecitabine) SPC available from:

http://www.medicines.org.uk/EMC/medicine/4619/SPC/Xeloda+150mg+and+500mg+Film-

coated+Tablets/

3. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus

treatment of physician's choice in patients with metastatic breast cancer

(EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011; 377:

914 -923

4. Cardoso, M. and Castiglione F. Locally recurrent or metastatic breast cancer:

ESMO Clinical Recommendations for diagnosis, treatment and follow-up. On

behalf of the ESMO Guidelines Working Group. Ann Oncol (2009) 20 (suppl 4):

iv15-iv18