Effectiveness, toxicity and treatment adjustments of lenvatinib plus pembrolizumab in advanced renal cell carcinoma: a multicenter real-world analysis
Year: 2025
Type: article
Study design: Observational Study
Abstract: Background: Combinations of checkpoint inhibitors and tyrosine kinase inhibitors are contemporary standards of care in first-line treatment of patients with advanced renal cell carcinoma. Real-world evidence remains scarce. Patients and methods: We retrospectively investigated the tolerability and effectiveness of lenvatinib plus pembrolizumab-approved based on the results of the CLEAR trial-under real-world conditions in 145 patients. Results: The median age was 63 years (range 21-87 years). The majority of patients were male (69%) and had a predominant clear-cell histology (88%). Adverse events (AEs) occurred in 94% of patients, with fatigue (50%), hypertension (39%) and diarrhea (38%) as most common AEs. Grade ≥3 AEs were seen in 59%. Interruption of at least one of the drugs due to toxicities was required in 68% of patients. The dose of lenvatinib was reduced in 56%. The objective response rate was 66%, with 8% of patients achieving a complete remission. Primary progression was seen in 8% of patients. At a median follow-up time of 12.2 months [95% confidence interval (CI) 10.3-15.5 months], 35% of patients experienced disease progression. Progression-free survival at 6 months was 76% (95% CI 71.9% to 79.7%). Twenty-one percent of patients died, most of them due to progressive disease. Limitations of our analysis are the short follow-up period and the retrospective nature of the analyses. Conclusions: Our cohort supports the use of lenvatinib plus pembrolizumab in a real-world population, including CLEAR-ineligible patients. However, AEs should be closely monitored and treatment should be adapted accordingly.
Institutions: Heidelberg University, University Hospital Heidelberg, National Center for Tumor Diseases, University Hospital Münster, TUM Klinikum, Technical University of Munich, Essen University Hospital, University of Duisburg-Essen, Johannes Gutenberg University Mainz, University Medical Center of the Johannes Gutenberg University Mainz, Universitätsmedizin Göttingen, University of Göttingen, Philipps University of Marburg, Universitätsklinikum Würzburg, Düsseldorf University Hospital, University Hospital Ulm, Ludwig-Maximilians-Universität München, University Hospital Bonn, Universitätsklinikum Krems, Karl Landsteiner University of Health Sciences, Bundeswehrzentralkrankenhaus Koblenz, Medizinische Hochschule Hannover, University of Cologne, University Hospital Cologne, Medizinische Fakultät Mannheim
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,170
OpenAlex ID: W4409427213