Eisai Europe Limited has announced that the National Institute for Health and Care Excellence (NICE) has given a positive recommendation for the use of Kisplyx® (lenvatinib) in combination with everolimus for the treatment of adults with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy, if their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1, and the company provides lenvatinib with the discount agreed in the patient access scheme.1
Lenvatinib is indicated in the European Union in combination with everolimus for the treatment of adult patients with advanced RCC following one prior vascular endothelial growth factor (VEGF)-targeted therapy.2
“We are delighted that NICE is recommending lenvatinib in combination with everolimus for routine access to adult patients for the treatment of advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. RCC is difficult to treat and patients therefore need effective alternative treatment options when their disease progresses,” commented Gary Hendler, Chairman & CEO EMEA, Chief Commercial Officer, Oncology Business Group at Eisai. “We look forward to a further recommendation by NICE for lenvatinib in early 2018 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), as this is long overdue and patients have had to wait for almost 3 years already.”
RCC is the most common type of kidney cancer in adults, with over 80% of kidney cancer patients in the UK diagnosed with this type.3 It has the highest mortality rate of the genitourinary cancers, as more than a third of patients with RCC will die from the disease.4
“This is tremendous news for people with advanced renal cell carcinoma. We have been eagerly awaiting this news from NICE for many months. It will be a great relief to patients and their families to know that their clinicians now have the lenvatinib plus everolimus combination as an effective treatment option in the second line,” commented Rose Woodward, Founder and Patient Advocate, Kidney Cancer Support Network. “Kidney cancer is a desperately difficult cancer to treat, and NHS patients need to be confident they can access the latest treatments when they need them. The kidney cancer community is especially grateful that NICE and Eisai have worked together to ensure patients have access to this new clinically effective drug combination.”
The decision by NICE is based on data from study 205, a randomised trial of 153 advanced RCC patients who had progressed after one previous VEGF therapy.5 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 (PFS) of 14.6 months compared with 5.5 months for those who received everolimus alone (n=50) (HR 0.40; 95% CI: 0.24–0.68; p=0.0005; investigator assessment).4 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; p=0.024 and HR 0.59; 95%CI: 0.36–0.97).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
- National Institute for Health and Care Excellence (NICE). Final appraisal determination. Lenvatinib with everolimus for previously treated renal cell carcinoma. Available at: https://www.nice.org.uk/guidance/gid-ta10125/documents/final-appraisal-determination-document. Last accessed December 2017
- European Medicines Agency (2016) Kisplyx Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004224/WC500216237.pdf Last accessed December 2017.
- Cancer Research UK (2016) Types of Kidney Cancer. Available at: http://www.cancerresearchuk.org/about-cancer/kidney-cancer/stages-types-grades/types-grades. Last accessed December 2017
- Cairns P. (2011) Renal Cell Carcinoma. Cancer Biomark. 9(1-6): 461–473
- Motzer R, et al (2016) Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncology. 16: 1473-82
- Dossier on the benefit assessment of § 35a SGB V, Lenvatinib (Kisplyx®), Eisai GmbH. Available at: https://www.g-ba.de/informationen/nutzenbewertung/261/ Last accessed December 2017.