German Federal Joint Committee (G-BA) Confirms Additional Benefit of Kisplyx® (lenvatinib) in Treatment of Advanced Renal Cell Carcinoma (RCC)

HATFIELD, England, March 27, 2017 /PRNewswire/ --

FOR EMEA HEALTHCARE AND MEDICAL MEDIA ONLY: NOT FOR SWISS/AUSTRIAN JOURNALISTS 

The decision recognises the convincing clinical benefit lenvatinib plus everolimus can offer to patients with advanced kidney cancer. 

The G-BA has confirmed the additional benefit of Kisplyx^® (lenvatinib) in combination with everolimus for the treatment of adults with advanced RCC versus everolimus alone.^[1] With this decision, the G-BA followed the recommendation of the German Institute for Quality and Efficiency in Health Care (IQWiG) published on 2 January 2017 thereby also affirming that the data presented by Eisai provided convincing evidence of a clinically meaningful added survival benefit for the combination.^[2]

RCC represents 2-3% of all cancer diagnoses^[3] and advanced disease is associated with high mortality. More than 30% of patients with advanced RCC do not survive^[4] and unfortunately 40-50% of patients with metastatic disease die within a year.^[5] Lenvatinib is indicated in combination with everolimus for the treatment of adult patients with advanced RCC following one prior vascular endothelial growth factor (VEGF)-targeted therapy.^[6]

"The G-BA decision is encouraging for clinicians and patients alike. In Study 205, patients treated with lenvatinib in combination with everolimus showed a median progression free survival of 14.6 months, which is far more than the clinical community expected to see in the second line RCC setting. This underscores the pivotal role that tyrosine kinase inhibitors still play in treating these patients," comments Prof. Dr. med Viktor Grünwald, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Germany.

The G-BA assessment was supported by data from study 205, a randomised trial of 153 advanced RCC patients who had progressed after one previous VEGF therapy.^[7] The results showed that there are significant differences in efficacy between the combination of lenvatinib and everolimus and everolimus monotherapy. When treated with lenvatinib in combination with everolimus (n=51), patients experienced a median progression-free survival of 14.6 months compared with 5.5 months for those who received everolimus alone (n=50) (HR 0.40; 95% CI: 0.24-0.67; p=0.0005; investigator assessment).^[7] Median overall survival (OS) in the study population was 25.5 months in the lenvatinib plus everolimus group compared with 15.4 months in the everolimus group in two update analyses (HR 0.51; 95% CI: 0.30-0.88 and HR 0.59; 95%CI: 0.36-0.97).^[8]

For lenvatinib in combination with everolimus, the most common any-grade treatment-emergent adverse events (TEAEs) were diarrhoea, decreased appetite and fatigue.^[8] The most common TEAEs of Grade 3 or higher in the combination arm were diarrhoea, fatigue and hypertension.^[8]

"We are pleased that the G-BA has acknowledged the value of lenvatinib in advanced RCC and confirmed the additional benefit of this novel therapeutic approach. By combining the different modes of action of lenvatinib and everolimus, a significant improvement in progression free survival was achieved compared to standard therapy, in addition to an unexpectedly high response rate. We will now enter discussions with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) to agree reimbursement prices following this decision," comments Georg Wager, General Manager, Eisai GmbH.

Lenvatinib is also indicated in the European Union for the treatment of adults with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).^[9]

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  

About Lenvatinib  

Lenvatinib is an oral multikinase inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor-alpha, and RET and KIT proto-oncogenes.^[10],[11]

About Everolimus 

Everolimus is a selective mTOR (mechanistic target of rapamycin) inhibitor. mTOR is a key serine-threonine kinase, the activity of which is known to be upregulated in a number of human cancers.^[12]

Eisai 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 combination with everolimus in the European Union for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
• Halaven^® (eribulin) is indicated in the European Union for the treatment of adults 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. Halaven^® (eribulin) is also 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.

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 www.eisai.com.

References  

1. G-BA Assessment Report. Available at: https://www.g-ba.de/informationen/beschluesse/2878/ Accessed March 2017

2. IQWiG Assessment Report. Available at: https://www.iqwig.de/en/projects-results/projects/drug-assessment/a16-63-lenvatinib-renal-cell-carcinoma-benefit-assessment-according-to-35a-social-code-book-v.7685.html#overview Accessed March 2017

3. Cohen H. T. und McGovern F. J. 2005. Renal-cell carcinoma. The New England Journal of Medicine 353 (23), S.

2477-2490.

4. Cairns P. 2011. Renal Cell Carcinoma. Cancer Biomarkers 9 (1-6), S. 461-473

5. Tumorregister München 2016. ICD-10 C64: Nierenkarzinom: Survival. Availble at: http://www.tumorregister-muenchen.de/facts/surv/sC64__G-ICD-10-C64-Nierenkarzinom-Survival.pdf Accessed March 2017

6. Fachinformation Kisplyx (Updated August 2016)  

7. Motzer R, et al. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncology.2015;16:1473-82.

8. Dossier on the benefit assessment of § 35a SGB V, Lenvatinib (Kisplyx®), Eisai GmbH. Available at: https://www.g-ba.de/informationen/nutzenbewertung/261/ , Accessed March 2017  

9. Fachinformation Lenvima (Updated September 2016).  

10. Matsui J, et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008;122:664-671.

11. Okamoto K, et al. Distinct Binding Mode of Multikinase Inhibitor Lenvatinib Revealed by Biochemical Characterization. ACS Medicinal Chemistry Letter 2010.

12. Fachinformation Afinitor (Updated June 2016)

March 2017

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