Lenvatinib's activity after immune checkpoint inhibitors (ICI) combination therapy in renal cell carcinoma (RCC) remains unknown. We aimed to describe the real-world outcomes of patients with metastatic RCC (mRCC) treated with lenvatinib after failure of the prior standard of care.
Multicenter retrospective study including patients with mRCC treated with lenvatinib-based therapies beyond first-line therapy between 2020 and 2024. The primary endpoints were objective response rate (ORR) and time-to-treatment failure (TTF). Secondary endpoints included disease control rate (DCR), overall survival (OS), and safety.
We included 133 patients, with a median age of 61 years. Clear-cell was the main subtype (82.0 %). Before lenvatinib treatment, 15.8 %, 51.9 %, and 27.8 % of patients showed favorable, intermediate, and poor risk disease, respectively, according to the International Metastatic RCC Database Consortium (IMDC). Moreover, patients received a median of 3 previous lines of treatment, including ICIs (90.2 %) and cabozantinib (90.2 %). Lenvatinib was given alone (45.9 %) or in combination with everolimus (33.8 %), pembrolizumab (18.0 %) or investigational agents (2.3 %). The ORR and DCR were 29.1 % and 67.7 %, respectively, with no differences between regimens or lines of treatment. With a median follow-up time of 13.5 months, the median TTF and OS were 6.2 and 9.6 months. Toxicity was manageable with dose modifications required in 34.6 %. The discontinuation rate was 9.8 %, with one toxic death.
Lenvatinib-based regimens were active and safe for heavily pre-treated patients with mRCC. These findings provide evidence to support its use in daily practice.
European journal of cancer (Oxford, England : 1990). 2025 Mar 26 [Epub ahead of print]
Javier Gavira, Edouard Auclin, Macarena Rey-Cardenas, Pritha Roy, Jose C Tapia, Paula Nay, Armelle Vinceneux, Felix Lefort, Simon Nannini, Adela Maria Del Carmen Randis, Natacha Naoun, Bernard Escudier, Delphine Borchiellini, Guillermo de Velasco, Philippe Barthelemy, Marine Gross-Goupil, Sylvie Negrier, Stéphane Oudard, Ricky D Frazer, Laurence Albiges, Ronan Flippot
Department of Medical Oncology, Gustave Roussy, Paris Saclay University, Villejuif, France; Department of Medical Oncology, Institut Català d'Oncologia, Hospitalet de Llobregat, Spain., Department of Medical Oncology, Institut Bergonié, Bordeaux, France., Department of Medical Oncology, Gustave Roussy, Paris Saclay University, Villejuif, France., Department of Clinical Oncology, Velindre Cancer Centre, Velindre University NHS Trust, Cardiff, Wales, United Kingdom., Department of Medical Oncology, Velindre Cancer Centre, Velindre University NHS Trust, Cardiff, Wales, United Kingdom., Department of Medical Oncology, Hôpital Européen Georges-Pompidou, University of Paris, Paris, France., Department of Medical Oncology, Centre Léon Bérard, University of Lyon, Lyon, France., Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France., Department of Medical Oncology, Institut de Cancérologie Strasbourg Europe, Strasbourg, France., Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain., Department of Medical Oncology, Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France., Department of Medical Oncology, Gustave Roussy, Paris Saclay University, Villejuif, France. Electronic address: .