German Institute for Quality and Efficiency in Health Care (IQWiG) Confirms Additional Benefit for Kisplyx® (lenvatinib) in Combination with everolimus for the Treatment of Advanced Renal Cell...

HATFIELD, England, January 4, 2017 /PRNewswire/ --

FOREU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN MEDIA 

Approximately 15,000 people in Germany develop renal cell carcinoma every year.^[1] 

The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which concludes that an additional benefit for Kisplyx^® (lenvatinib) in combination with everolimus for the treatment of advanced renal cell carcinoma (RCC) versus the established comparator therapy - as defined by the Federal Joint Committee (G-BA) - has been proven.^[2]

The final decision to implement the report's recommendation lies with the G-BA and is expected for March 2017. It will follow consideration of the IQWiG report, written statements and an oral hearing.

Eisai´s request for an accelerated assessment was agreed upon by the Committee for Medicinal Products for Human Use (CHMP) on 19 November 2015 as the product was considered to be of major public health interest.^[3] In August 2016, the European Commission issued the Marketing Authorisation for lenvatinib in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF)-targeted therapy.^[4]

In the pivotal phase II trial (study 205),^[5] 153 people living with advanced RCC who had progressed after one previous VEGF therapy were evaluated.^[5] In the study, patients were randomised to either receive everolimus or lenvatinib monotherapy, or the combination of both agents. The results from study 205 revealed that there are significant differences in efficacy between the combination treatment 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).^[5] 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).^[6] The absolute difference in median OS of 10.1 months shown in these analyses suggests a large and sustained improvement in overall survival.^[6]

For lenvatinib in combination with everolimus, the most common any-grade treatment-emergent adverse events (TEAEs) were diarrhoea, decreased appetite and fatigue.^[5] The most common TEAEs of Grade 3 or higher in the combination arm were diarrhoea, fatigue and hypertension.^[5]

"This news will be welcomed by clinicians and patients alike. The phase II trial was the first to successfully combine these two types of cancer drug in renal cell carcinoma and there are currently few efficacious treatment options available in Germany," comments Dr. med. Helga Schmitz, Medical Director, Eisai GmbH.

Renal cell carcinoma represents 2-3% of all cancer diagnoses.^[7] Around 15,000 people in Germany develop renal cell carcinoma each year, and there are few effective systemic treatment options for this type of cancer in advanced stage.^[1]

"Eisai is encouraged by the fact that IQWiG has confirmed the additional benefit for lenvatinib in combination with everolimus in renal cell carcinoma. Eisai remains committed to exploring new and innovative uses for this important anti-cancer therapy for the benefit of patients around the world," comments Dr Patrik Höller, Director Business Group Oncology, Eisai GmbH.

Lenvatinib is also 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).^[8]

The development of lenvatinib underscores Eisai's 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 to address the unmet medical needs of patients and their families.

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.^[9],[10]

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.^[11]

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 received 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 http://www.eisai.com.

References  

1. Schrader J, et al. Renal Cell Carcinoma Update: News from the AUA, EAU, and ASCO Annual Meetings 2011. ISRN Urology 2012. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3384960/ [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3384960 ] Accessed in January 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 [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 ]

3. European Medicine Agency. Kisplyx: EPAR. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004224/WC500216286.pdf   Accessed in December 2016.

4. Fachinformation Kisplyx (Stand August 2016).

5. 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.

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

7. National Cancer Institute at the National Institute of Health. Available at: http://www.cancer.gov/types/kidney/hp/kidney-treatment-pdq . Accessed in September 2016

8. Fachinformation Lenvima (Stand Mai 2015).

9. 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.

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

11. Fachinformation Afinitor. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001038/WC500022814.pdf Accessed in January 2017.

January 2017  
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