Phase III Trial of Anticancer Agent Halaven® (eribulin) in Soft Tissue Sarcoma Shows Overall Survival Benefit in Primary Endpoint

HATFIELD, England, February 25, 2015 /PRNewswire/ --

Eisai demonstrates commitment to rare cancers  

Eisai announces today that in the Phase III trial (Study 309) of Halaven^® (eribulin) in patients with soft tissue sarcoma, eribulin demonstrates a statistically significant extension in overall survival (OS) over the comparator treatment dacarbazine, the primary endpoint of the study. No other systemic treatment for locally advanced or metastatic soft tissue sarcoma has been reported to extend overall survival in a Phase III study.^[1] Eribulin, as a single agent, now demonstrates overall survival benefit in two distinct solid tumour types (advanced breast cancer and soft tissue sarcomas), following two prior regimens in the advanced setting. Eisai will seek to present these data at an upcoming peer review forum as soon as possible.

Soft tissue sarcomas are cancers that develop from cells in the soft, supporting tissues of the body such as fat, muscle, nerves, fibrous tissues and blood vessels.^[2]

"Overall Survival is recognised as the most definitive cancer outcome and is universally accepted as the direct measure of benefit in cancer treatments and this study demonstrates that eribulin has the potential to become an important additional treatment option for patients with this aggressive and rare cancer that requires chemotherapy," commented Gary Hendler, CEO Eisai EMEA and President, Global Oncology Business Unit.

Study 309 was a randomised, open-label multicentre Phase III study comparing the efficacy and safety of eribulin in 452 patients (aged 18 or over). Treatment was administered on days one and eight of a 21-day cycle versus dacarbazine to patients with one of two subtypes: adipocytic or leiomyosarcoma locally advanced or relapsed and metastatic soft tissue sarcoma who showed disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen.^[1]

The primary endpoint of the study was to compare overall survival between both treatment arms, and the additional endpoints include progression free survival and quality of life. In this study, the most common adverse events observed in the eribulin arm were neutropenia, fatigue, nausea, alopecia and constipation, which is consistent with the known profile of eribulin.^[1]

Eisai intends to submit applications during the first half of the fiscal year of 2015 to the regulatory authorities in multiple countries which include the United States, Europe and Japan seeking an expansion of the indication for eribulin including soft tissue sarcoma.

First in the halichondrin class, eribulin is a microtubule dynamics inhibitor 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 currently indicated for the treatment of advanced breast cancer and is approved in 60 countries worldwide including Asia, Australia, the European Union, Japan, Russia, Switzerland and the Americas.

In Europe, soft tissue sarcoma affects 4-5 people in every 100,000.^[3] Approximately 11,930 cases of soft tissue sarcoma will be diagnosed in the United States this year.^[4] In Japan, approximately 2,000 cases of soft tissue sarcoma are diagnosed each year.^[5],[6]

Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of women 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  

About Soft Tissue Sarcoma  

Soft tissue sarcoma is a collective term for a diverse group of malignant tumours that are relatively rare. The annual incidence of soft tissue sarcoma is approximately 50 cases per million of the population globally. Unlike other cancers such as non-small cell lung cancer (NSCLC), soft tissue sarcomas are mostly diagnosed with localised disease, and many are amenable to complete surgical removal, yet relapse rates can be as high as 50 percent.^[7] Outcomes for patients with advanced disease are poor, with median survival around 1 year or less. Due to the rarity of these tumours, evidence for prognostic factors is weak and not well understood.^[8]

Halaven^® (eribulin)  

Eribulin is currently indicated for the treatment of women 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.^[9]

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.

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. Clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01327885?term=halaven+soft+tissue+sarcoma&rank=2 Accessed: February 2015

2. Macmillan. What are soft tissue sarcomas?       http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Softtissuesarcomas/Aboutsofttissuesarcomas/Softtissuesarcomas.aspx . Last accessed February 2015

3. ESMO Guidance: http://www.esmo.org/Guidelines/Sarcoma-and-GIST/Soft-Tissue-and-Visceral-Sarcomas . Accessed February 2015

4. National Cancer Institute http://www.cancer.gov/cancertopics/pdq/treatment/adult-soft-tissue-sarcoma/HealthProfessional/page1 . Accessed February 2015

5. M. Schuichi, et al. Soft-Tissue Sarcoma Surveillance Counterpoint: Japan. Current Clinical Oncology. 2013; 233-234

6. H. Tsujii, et al. Carbon-Ion Radiotherapy: Principles, Practices, and Treatment Planning. Springer. 2014; (XII)312:237

7. R. Pollock. Soft Tissue Sarcomas: A Volume in the American Cancer Society Atlas of Clinical Oncology Series. 2012

8. Fletcher et al. World Health Organization Classification of Tumours of Soft Tissue and Bone (4th Edition). Lyon: IARC Press, 2013.

9. SPC Halaven (updated June 2014). Available at: http://www.medicines.org.uk/emc/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/ Accessed: February 2015

Date of preparation: February 2015

Job code: Halaven-UK0402