HATFIELD, England, December 4, 2016 /PRNewswire/ --
FOR EMEA MEDIA ONLY: NOT FOR SWISS/AUSTRIAN JOURNALISTS
Eribulin has shown unprecedented survival benefit in advanced liposarcoma in pivotal phase III trial
The German Federal Joint Committee (G-BA) has confirmed the considerable additional benefit for Halaven® (eribulin) compared to dacarbazine in the treatment of unresectable advanced or metastatic liposarcoma. In its assessment, the G-BA found the data for mortality, symptoms and quality of life, which showed an additional benefit over the appropriate comparator, to be decisive. With its decision, the G-BA did not follow the recommendation of the German Institute for Quality and Efficiency in Health Care (IQWiG) - put forward in September this year - to not grant an additional benefit based on formal grounds only which resulted in the IQWiG not evaluating the clinical data provided by Eisai initially. In contrast, the G-BA judged the substantial survival benefit eribulin offers to patients with advanced liposarcoma to be a clinically relevant and considerable improvement of the therapy-relevant benefit.
Eribulin is indicated in the European Union for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
Liposarcomas are one of the most common subtypes of soft tissue sarcomas (STS)., STS develop from cells in essential tissues such as muscle, nerves, fibrous tissues and blood, with liposarcomas arising from fat cells and potentially occurring anywhere in the body.
"It is very encouraging that the G-BA has recognised the benefit eribulin offers to patients with advanced liposarcoma. Given the limited treatment options for this condition, new and effective therapies are urgently needed. Eribulin clearly addresses this need as it has demonstrated a statistically significant and relevant survival advantage over dacarbazine, an established and internationally accepted treatment option for advanced soft tissue sarcoma," comments Prof. Dr. Viktor Grünwald, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover.
The G-BA assessment was supported by data from study 309, a randomized phase III trial in unresectable advanced or metastatic pretreated leiomyosarcoma or liposarcoma patients. The results showed that eribulin significantly improves overall survival (OS) versus dacarbazine in a preplanned subgroup analysis of patients with advanced liposarcoma. In this study, patients with liposarcoma that were treated with eribulin had a 7.2 months longer median overall survival than those treated with dacarbazine (15.6 months versus 8.4 months median OS, HR = 0.511; 95% CI 0.346-0.753; p=0.0006). The most common (above 5%) adverse events of Grade 3 or 4 observed in the eribulin arm were neutropenia, anaemia and leukopenia, and in the dacarbazine arm were anaemia, neutropenia and thrombocytopenia.
"We are pleased that the G-BA - the supreme decision making body in German statutory healthcare - recognised the considerable value eribulin brings to people with unresectable advanced or metastatic liposarcoma compared to dacarbazine. Advanced liposarcoma is the second tumour type in which eribulin has demonstrated an overall survival benefit. We believe eribulin offers an unprecedented benefit to patients in Germany, and look forward to positive talks with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) to negotiate reimbursement prices based on this favourable G-BA decision," comments Dr. Patrik Höller, Director Oncology Business Group, Eisai GmbH, Frankfurt, Germany.
Eribulin is also licensed in the European Union 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.
Eisai is dedicated to the discovery, development and production of 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 to better understand the needs of patients and their families to increase the benefits health care provides.
Notes to Editors
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.
Global Phase III Clinical Study 309
Study 309 is a randomised, open-label multicentre phase III study to compare the efficacy and safety of eribulin mesylate (1.4 mg/m2, IV on days 1 and 8) to dacarbazine (850, 1,000 or 1,200 mg/m2, IV on day 1) with both drugs administered in a 21-day cycle. 452 patients (aged 18 or over) with soft tissue sarcomas of leiomyosarcoma or liposarcoma subtype were randomized 1:1. The primary endpoint of the study was overall survival. Additional endpoints included progression-free survival and quality of life.
About Eisai EMEA in Oncology
Eisai is committed to the development and delivery of highly beneficial new treatments for people with cancer. The development of therapeutic options in oncology is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA). In the European Union, Eisai currently has three marketed treatments across four indications:
- Lenvima® (lenvatinib) is indicated in the European Union for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).
- Kisplyx® (lenvatinib) is indicated in the European Union in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
- Halaven® (eribulin) is indicated in the European Union for the treatment of people with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens 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. Halaven® (eribulin) is also indicated in the European Union for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
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 close to 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.
1. Schöffski P et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016
2. Beschluss und Tragende Gründe des G-BA: https://www.g-ba.de/informationen/beschluesse/2775/ . Accessed: December 2016
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4. Schwartz R, et al. Liposarcoma. Medscape. 2013. Available at: http://emedicine.medscape.com/article/1102007-overview . Accessed December 2016
5. Macmillan. Types of soft tissue sarcoma. Available at: http://www.macmillan.org.uk/cancerinformation/cancertypes/softtissuesarcomas/aboutsofttissuesarcomas/typesofsofttissuesarcoma.aspx Accessed: December 2016
6. Macmillan. What are soft tissue sarcomas? Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Softtissuesarcomas/Aboutsofttissuesarcomas/Softtissuesarcomas.aspx. Accessed: December 2016