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. 2025 Apr 1:6:1002305.
doi: 10.37349/etat.2025.1002305. eCollection 2025.

Real-world outcomes of lenvatinib plus pembrolizumab in intermediate- and poor-risk metastatic renal cell carcinoma

Ilya Tsimafeyeu  1 , Alexander Sultanbaev  2 , Daria Dubovichenko  3 , Makhabbat Murzalina  4 , Alexander Volkov  5 , Rashida Orlova  6 , Igor Utyashev  7 , Georgy Malina  8 , Mark Gluzman  6
Affiliations

Real-world outcomes of lenvatinib plus pembrolizumab in intermediate- and poor-risk metastatic renal cell carcinoma

Ilya Tsimafeyeu et al. Explor Target Antitumor Ther. .

Abstract

The combination of lenvatinib and pembrolizumab (Len + Pembro) demonstrated significant efficacy in the phase 3 CLEAR study for metastatic renal cell carcinoma (RCC). However, poor-risk patients represented only a small proportion of the trial population. This multicenter retrospective cohort study assessed the real-world efficacy and safety of Len + Pembro in patients with clear-cell metastatic RCC and intermediate or poor International Metastatic RCC Database Consortium risk. Outcomes included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Sixty patients were analyzed, with a median age of 56 years. Poor risk was identified in 53% of patients, and 90% had metastases to ≥ 2 organs. ORR was 48.33%, disease control rate was 86.7%, and median PFS was 19.0 months. Grade ≥ 3 adverse events occurred in 25% of patients, with 33.3% requiring lenvatinib dose reductions. Lenvatinib plus pembrolizumab demonstrated robust efficacy and a manageable safety profile in a real-world population with advanced disease and poor-risk features, consistent with outcomes reported in clinical trials.

Keywords: IMDC intermediate and poor risk; Metastatic renal cell carcinoma; lenvatinib plus pembrolizumab; real-world evidence.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Kaplan-Meier curve for PFS. PFS: progression-free survival; CI: confidence intervals; OS: overall survival
See this image and copyright information in PMC

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