Activity of lenvatinib-based therapy in previously treated patients with metastatic renal cell carcinoma: a European multicenter study (LENVA-LAT)
Menée à partir de données européennes portant sur 133 patients atteints d'un carcinome à cellules rénales de stade métastatique (âge médian : 61 ans ; durée médiane de suivi : 13,5 mois), cette étude multicentrique évalue l'efficacité, du point de vue du taux de réponse objective et du délai avant échec du traitement, de stratégies à base de lenvatinib après l'échec de plusieurs lignes thérapeutiques
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.