New Halaven® (Eribulin) and Lenvatinib Data to be Presented at ESMO 2014 Demonstrates Strength of Eisai Oncology Portfolio
HATFIELD, England, September 17, 2014 /PRNewswire/ --
FOR EMEA MEDIA ONLY: NOT FOR SWISS/U.S. JOURNALISTS
Wealth of data highlights Eisai's commitment to people with cancer and their families
Nine abstracts for Eisai's oncology portfolio are to be presented during the European Society for Medical Oncology (ESMO) 2014 Congress, in Madrid, Spain between 26 and 30 September, 2014.
Data to be presented include three abstracts for Halaven® (eribulin). Eribulin is indicated in Europe for the treatment of 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 in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.[1]
Five abstracts for lenvatinib, an investigational agent being evaluated for the treatment of progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC), will be presented. Lenvatinib received accelerated European Medicines Agency (EMA) review on the 31 July and was filed in Europe and the U.S. on 18 August 2014. Lenvatinib was filed in Japan in June 2014. Lenvatinib was granted orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer by the European Commission in April 2013. It has ODD for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer in the U.S. and thyroid cancer in Japan.
An abstract for the Eisai developed PARP inhibitor E7449 will feature at the congress.
"We are very excited to share important data that further demonstrates the strength of our oncology portfolio at ESMO 2014. Eisai is committed to the provision of a range of options to help reduce the significant burden of cancer for patients, their families and healthcare systems," commented Gary Hendler, President & CEO Eisai EMEA and President, Eisai Oncology Global Business Unit.
The following Eisai abstracts are accepted for presentation at this year's ESMO Congress:
Product Abstract Name
Impact of treatment with eribulin or capecitabine for
Eribulin metastatic breast cancer on EQ-5D utility derived from
EORTC QLQ-C30.
Abstract No:
1046P Poster Display Session
Efficacy of eribulin in a second-line or later setting
in patients with metastatic breast cancer: a pooled
Eribulin analysis.
Abstract No: 393P Poster Display Session
HRQOL and disease symptoms in patients with locally
advanced or metastatic breast cancer treated with
eribulin or capecitabine in a post anthracycline and
Eribulin taxane setting.
Abstract No: 392P Poster Display Session
Lenvatinib Comprehensive analysis of serum biomarker and tumour
gene mutation associated with clinical outcomes in the
(E7080) phase III Study of (E7080) LEnvatinib in differentiated
Cancer of the Thyroid (SELECT).
Abstract No:
LBA30 Proferred Paper Session
Lenvatinib Phase II study of lenvatinib, a multi-targeted tyrosine
kinase inhibitor, in patients with all histologic
(E7080) subtypes of advanced thyroid cancer (differentiated,
medullary and anaplastic).
Abstract No:
995PD Poster Discussion session
Lenvatinib Subgroup analyses of a phase III, multicenter,
double-blind, placebo controlled trial of lenvatinib
(E7080) (E7080) in patients with 131I-refractory differentiated
thyroid cancer.
Abstract No:
1033P Poster Display Session
Lenvatinib
Treatment-emergent hypertension and efficacy in the
(E7080) phase III Study of (E7080) LEnvatinib in differentiated
Cancer of the Thyroid (SELECT).
Abstract No:
1030P Poster Display Session
Lenvatinib
Characterisation of tumour size changes over time from
(E7080) the phase III Study of (E7080) LEnvatinib in
differentiated Cancer of the Thyroid (SELECT).
Abstract No:
1031P Poster Display Session
Phase 1 study of the PARP inhibitor E7449 as a single
agent in patients with advanced solid tumors or B-cell
E7449 lymphoma
Abstract No: 453P Poster Display Session
The development of Eisai's oncology portfolio underscores its human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of oncology and addressing the unmet medical needs of patients and their families.
Notes to Editors
Halaven® (eribulin)
Eribulin is the first in the halichondrin-related class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a synthetic copy 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.
Eribulin is 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.
Metastatic Breast Cancer
Over 300,000 women are diagnosed with breast cancer in Europe every year, of whom about one third subsequently develop metastatic disease.[2],[3]Metastatic disease is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body.
Lenvatinib (E7080)
Lenvatinib, discovered and developed by Eisai, is an oral multiple receptor tyrosine kinase (TKI) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor receptors (VEGFR), in addition to other proangiogenic and oncogenic pathway-related TKIs including fibroblast growth factor receptors (FGFR), the platelet-derived growth factor (PDGF) receptor PDGFRα, KIT and RET that are involved in tumour proliferation.[4],[5] This potentially makes lenvatinib the first TKI that simultaneously inhibits the kinase activities of FGFR 1-4 as well as VEGFR 1-3. It is currently under investigation as a treatment for thyroid, hepatocellular carcinoma (Phase III), non-small cell lung cancer (Phase II) and other solid tumour types.
About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.[6] It is more common in women than in men and most are in their 40s or 50s at time of diagnosis.[7]Thyroid cancer is the most common endocrine malignancy and global figures show that its incidence has increased significantly over the last 50 years. [7]
The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 90% of all cases.[8] The remaining cases are classified as either medullary (5-7% of cases) or anaplastic (1-2% of cases).[9]While most DTC patients are curable with surgery and radioactive iodine treatment, the prognosis for those patients who do not respond is poor.[10] There are limited treatment options for this difficult-to-treat, life-threatening and treatment-refractory form of thyroid cancer.[11]
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
Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and 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 human health care (hhc).
Eisai concentrates its R&D activities in three key areas:
- Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc
- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight management
- Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease
With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, the Middle East, the Netherlands, Norway, Portugal, Russia, Slovakia, Spain, Switzerland, Sweden, and the United Kingdom.
For further information please visit our web site: http://www.eisai.co.uk
References
1. SPC Halaven (updated June2014). Available at: http://www.medicines.org.uk/emc/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/ Accessed: August 2014
2. World Health Organisation. Atlas of Health in Europe. 2003. World Health Organization, Regional Office of Europe, Copenhagen, Denmark.
3. Cancer Research UK. Breast cancer incidence statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence/#world Accessed: August 2014.
4. Matsui J, et al. Clin Cancer Res 2008;14:5459-65
5. Matsui J, et al. Int J Cancer 2008;122:664-71
6. National Cancer Institute at the National Institute of Health. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages#1 Accessed: July 2014
7. Brito J et al. BMJ 2013; 347
8. Cooper DS et al. Thyroid. 2009;19(11):1167-1214
9. Thyroid Cancer Basics. 2011. Available at: http://www.thyca.org. Accessed: August 2014
10. Gild M et al. Nature Reviews Endocrinology. 2011; 7: 617-624
11. Bible K, et al. Lancet Oncology 2010;11(10):962-972
Date of preparation: September 2014
Job code: Oncology-UK0019
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