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.
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.
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.
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.
ESMO real world data and digital oncology. 2025 Apr 14*** epublish ***
R Stelmach, S Erdmann, K Schlack, C Muehle, C Darr, S Neuberger, M Reichert, L Flegar, T Egenolf, M Rehlinghaus, F Zengerling, J Casuscelli, A Cox, S Vallet, T Nestler, B Brehmer, P Ivanyi, P Paffenholz, M Neuberger, D Jäger, V Grünwald, S Zschäbitz
Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany., Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany., Department of Urology, University Hospital Muenster, Muenster, Germany., Department of Urology, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany., Department of Urology, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany., Department of Urology and Pediatric Urology, University Medical Center of Johannes Gutenberg University, Mainz, Germany., Department of Urology, University Medicine Goettingen, Goettingen, Germany., Department of Urology, Philipps-University Marburg, Marburg, Germany., Department of Urology and Pediatric Urology, University Hospital Würzburg, Würzburg, Germany., Department of Urology, University Hospital Düsseldorf, Düsseldorf, Germany., Department of Urology and Pediatric Urology, University Hospital Ulm, Ulm, Germany., Department of Urology, University Hospital, Ludwig Maximilian University of Munich, Munich, Germany., Department of Urology, University Hospital Bonn, Bonn, Germany., Department of Internal Medicine 2, University Hospital Krems and Karl Landsteiner University of Health Sciences, Krems an der Donau, Austria., Department of Urology, Federal Armed Forces Hospital Koblenz, Koblenz, Germany., Department of Urology, Diakonie Hospital, Schwaebisch Hall, Germany., Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Claudia-von Schelling Comprehensive Cancer Center, Hannover Medical School, Hannover, Germany., Department of Urology, Uro-Oncology, Robot Assisted and Reconstructive Urologic Surgery, University of Cologne Faculty of Medicine and University Hospital Cologne, Cologne, Germany., Department of Urology and Urological Surgery, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany.