Eisai Europe Limited

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

Hatfield, England (ots/PRNewswire) - Eisai Europe Limited today announces preliminary results from a recently completed Phase III study (Study 301) comparing Halaven(R) (eribulin) and Xeloda(R) (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/m2 (administered intravenously over two to five minutes on days 1 and 8, every 21 days) or capecitabine 2.5g/m2(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(R) (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.or g.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+Tabl ets /

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

Contact:

Media Enquiries: Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44-(0)7947-231513 / +44-(0)790-831-4155 ,
Charlotte_andrews@eisai.net / Cressida_robson@eisai.net . Tonic Life
Communications: Benjamyn Tan / Leah Peyton, +44-(0)207-798-9262 /,
+44-(0)7788-191434, benjamyn.tan@toniclc.com,
eisaioncology@toniclc.com


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