Background. The combination of lenvatinib and pembrolizumab 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. Aim. This multicenter retrospective cohort study assessed the real-world efficacy and safety of lenvatinib plus pembrolizumab in patients with clear-cell metastatic RCC and intermediate or poor International Metastatic RCC Database Consortium risk. Materials and methods. Outcomes included objective response rate, progression-free survival, overall survival, 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. Results. Objective response rate was 48.33 %, disease control rate was 86.7 %, and median progression-free survival was 19.0 months. Grade ≥3 adverse events occurred in 25 % of patients, with 33.3 % requiring lenvatinib dose reductions. Conclusion. 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.
Tsimafeyeu et al. (2025) studied this question.