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Multicenter Study
. 2025 May 2:220:115389.
doi: 10.1016/j.ejca.2025.115389. Epub 2025 Mar 26.

Activity of lenvatinib-based therapy in previously treated patients with metastatic renal cell carcinoma: A European multicenter study (LENVA-LAT)

Javier Gavira  1 , Edouard Auclin  2 , Macarena Rey-Cardenas  3 , Pritha Roy  4 , Jose C Tapia  5 , Paula Nay  6 , Armelle Vinceneux  7 , Felix Lefort  8 , Simon Nannini  9 , Adela Maria Del Carmen Randis  10 , Natacha Naoun  3 , Bernard Escudier  3 , Delphine Borchiellini  11 , Guillermo de Velasco  10 , Philippe Barthelemy  9 , Marine Gross-Goupil  8 , Sylvie Negrier  7 , Stéphane Oudard  6 , Ricky D Frazer  5 , Laurence Albiges  3 , Ronan Flippot  12
Affiliations
Multicenter Study

Activity of lenvatinib-based therapy in previously treated patients with metastatic renal cell carcinoma: A European multicenter study (LENVA-LAT)

Javier Gavira et al. Eur J Cancer. .

Abstract

Background and objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: Efficacy; Kidney cancer; Later lines; Lenvatinib; Outcomes; Real-world data; Renal Cell Carcinoma; Safety.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JG: Speaker’s bureau: LEO Pharma, Astellas Pharma. Travel, accommodations, expenses: Lilly, Ipsen, Novartis, Roche, and Bayer. None of these is related to this manuscript. EA: none. MRC: none. PR: none. JCT: Speaker's Bureau: Eisai. Travel, Accommodations, and expenses: Pfizer, Roche/Genentech, Lilly, and BMS. PN: none. AV: none. FL: Honoraria: BMS, Ipsen, Pfizer, Eisai, MSD. Travel, accommodations, expenses: BMS, Ipsen, MSD, Eisai. SN: none. AMR: none. NN: Speaker's Bureau: Pfizer (inst). Expert Testimony: Merck Sharp & Dohme. Travel, Accommodations, and expenses: Merck Sharp & Dohme, Pfizer. BE: Honoraria: BMS, Ipsen, Oncorena, Pfizer. Consulting or advisory role: AVEO, BMS, Ipsen, Oncorena, and Pfizer. Research Funding: BMS France (inst). Travel, Accommodations, and expenses: BMS, Ipsen and MSD. DB: none. GDV: none. PB: Honoraria: AstraZeneca, BMS, Ipsen, Pfizer, Eisai, MSD, Bayer, Janssen, Astellas, Accord Healthcare, Gilead, Merck and Novartis. Consulting or advisory role: BMS, Ipsen, Pfizer, Eisai, MSD, Merck, Gilead, Janssen, Bayer, AstraZeneca, Astellas. Research Funding: BMS France, Ipsen. Travel, Accommodations, and expenses: Ipsen, MSD, Merck, and AstraZeneca. MGG: Astellas, Bayer, BMS, Gilead, Ipsen, MSD, Pfizer, Eisai. Travel, Accommodations, and expenses: Bayer, Ipsen, MSD, Pfizer, and Janssen. SN: Honoraria: Pfizer, Ipsen, BMS, MSD, Eisai. Travel, Accommodations, and expenses: BMS, Pfizer, Ipsen, MSD. Research Funding: Pfizer (inst), Ipsen (inst). None of these related to this manuscript. SO: Hononaria: BMS, Ipsen, Pfizer, Eisai, and Novartis. Consulting or advisory role: BMS, Ipsen, Pfizer, and Eisai. Research Funding: BMS France, Ipsen. Travel, Accommodations, and expenses: Ipsen, MSD. RDF: Speaking and/or advisory fees for: BMS, Eisai, Ewopharma, Ipsen, MSD, Novartis, Pfizer, Pierre Fabre, Recordati, Regeneron, Roche, Sanofi, and Servier SUN Pharma. LA: Honoraria: Astellas, Eisai, Ipsen, Hoffmann-La Roche, BMS, Janssen, and Merck Sharp & Dohme. Travel, Accommodation, and expenses: Merck Sharp & Dohme and BMS. RF: Hononaria: Bayer, Astellas, Janssen, BMS, MSD, Ipsen, Merckl Sharp & Dohme.

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