(UroToday.com) Lenvatinib is a multi-targeted TKI that is approved in combination with everolimus to treat patients with advanced renal cell carcinoma (RCC), following one prior antiangiogenic therapy. While the combination therapy regimen resulted in improvements in progression-free survival, patients treated with the regimen experience adverse events that often lead to dose reductions and interruptions.1 Study 218 was a phase II study evaluating lenvatinib 14 mg versus lenvatinib 18 mg, both in combination with everolimus 5 mg, for the treatment of clear cell RCC following treatment with a VEGF-targeted therapy. The primary endpoint for this study was previously presented, noting that the lenvatinib 14 mg arm did not demonstrate noninferiority versus the lenvatinib 18 mg arm for objective response rate as of week 24 by investigator assessment (OR 0.88, 90% CI 0.59-1.32). At the 2021 GU ASCO annual meeting, Dr. Sumanta Pal and colleagues presented results of an exploratory analysis of Study 218, evaluating the efficacy of lenvatinib 14 mg versus lenvatinib 18 mg, both in combination with everolimus 5 mg, per independent imaging review assessment and by prior immune checkpoint inhibitor status per investigator assessment.

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