Lenvatinib Plus Pembrolizumab Versus Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma: Final Prespecified Overall Survival Analysis of CLEAR, a Phase III Study
Lenvatinib
Clinical endpoint
Discontinuation
DOI:
10.1200/jco.23.01569
Publication Date:
2024-01-16T20:59:13Z
AUTHORS (241)
ABSTRACT
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary point, may be published when key planned co-primary or secondary analyses are not yet available. trial updates provide an opportunity to disseminate additional results from studies, in JCO elsewhere, for which point has already been reported. We present final prespecified overall survival (OS) analysis of open-label, phase III CLEAR study treatment-naïve patients with advanced renal cell carcinoma (aRCC). With follow-up 23 months analysis, we report lenvatinib plus pembrolizumab versus sunitinib comparison CLEAR. Treatment-naïve aRCC were randomly assigned receive (20 mg orally once daily 21-day cycles) (200 intravenously every 3 weeks) (50 [4 weeks on/2 off]). At this data cutoff date (July 31, 2022), OS hazard ratio (HR) was 0.79 (95% CI, 0.63 0.99). median CI) 53.7 48.7 estimable [NE]) 54.3 40.9 NE) sunitinib; 36-month rates 66.4% 61.1 71.2) and 60.2% 54.6 65.2), respectively. progression-free 23.9 20.8 27.7) 9.2 6.0 11.0) (HR, 0.47 [95% 0.38 0.57]). Objective response rate also favored combination over (71.3% v 36.7%; relative risk 1.94 1.67 2.26]). Treatment-emergent adverse events occurred >90% who received either treatment. In conclusion, achieved consistent, durable benefit a manageable safety profile aRCC.
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