Results published in J Clin Oncol. Study 205 was a multicenter, randomised, open-label study of lenvatinib (18 mg) in combination with everolimus (5 mg), lenvatinib alone (24 mg), and everolimus alone (10 mg) in patients with advanced or metastatic renal cell carcinoma following one prior VEGF-targeted therapy. 153 patients were randomized in a 1:1:1 ratio to one of three treatment arms to compare the safety and efficacy of these three regimens. From the results of the study, the combination of lenvatinib plus everolimus demonstrated a significant extension in the study′s primary endpoint of progression free survival (PFS) compared to everolimus alone (median PFS for the lenvatinib plus everolimus group: 14.6 months vs median PFS for the everolimus alone group: 5.5 months; Hazard Ratio (HR) 0.40 [95% CI: 0.24-0.68], p<0.001). Additionally, median PFS for lenvatinib alone was 7.4 months, demonstrating an extension in PFS compared to everolimus alone (HR: 0.61 [95% CI: 0.38-0.98]). The study also assessed objective response rate (ORR) and overall survival (OS) as secondary endpoints. Regarding ORR, both the lenvatinib plus everolimus group and the lenvatinib alone group showed an improvement in ORR compared to the everolimus alone group (lenvatinib plus everolimus: 43%, lenvatinib alone: 27%, everolimus alone: 6%). Furthermore, regarding OS, an updated analysis carried out in December 2014 suggested that lenvatinib plus everolimus extends OS compared to everolimus alone (HR 0.51 [95% CI=0.30-0.88]). The most common treatment-emergent adverse events (TEAE) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher included diarrhea, hypertension and fatigue [2].
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Evidence Based eva luations
NIHR HSRIC http://www.hsric.nihr.ac.uk/topics/lenvatinib-in-combination-with-everolimus-for-advanced-or-metastatic-renal-cell-carcinoma-second-line/
References
Available only to registered users
Category
BNF Category: Other antineoplastic drugs (08.01.05)
Pharmacology: A multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of several receptors involved in tumour proliferation [1]
Epidemiology: Renal cell carcinoma comprises more than 90% of all malignancies of the kidney and is thought to affect 338,000 people worldwide [1]
Indication: Renal cell carcinoma
Additional Details: advanced and/or metastatic, combination therapy with everolimus - second-line therapy or greater
Method(s) of Administration
Oral
Company Information
Name: Eisai
US Name: Eisai
Further Information
Anticipated commissioning route (England) NHSE
High cost drug list? Awaiting Update
Tariff Chemotherapy is locally negotiated
Implications Available only to registered users |
