Lenvatinib (Len) plus everolimus (Eve) is an approved therapy for metastatic renal cell carcinoma (mRCC) after first-line vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKI), but limited data exist on the efficacy of Len +/- Eve after progression on immune checkpoint inhibitors (ICI) and VEGFR-TKI.
We retrospectively reviewed the records of patients with mRCC at our institution who were treated with Len +/- Eve after ICI and VEGFR-TKI. A blinded radiologist assessed objective response as defined by RECIST v1.1. Descriptive statistics and the Kaplan-Meier method were used.
55 patients were included in the analysis. 81.8% had clear-cell histology (ccRCC) and 76.4% had IMDC intermediate-risk disease. Median number of prior therapies was 4 (range, 2-10); all patients had prior ICI and VEGFR-TKI, and 80% were previously treated with ICI and ≥2 VEGFR-TKI, including cabozantinib. One patient (1.8%) achieved a complete response and 11 patients (20.0%) achieved a partial response, for an overall response rate (ORR) of 21.8%; 35 patients (63.6%) achieved stable disease. In all patients, median progression-free survival (PFS) was 6.2 months (95% CI, 4.8-9.4) and median overall survival (OS) was 12.1 months (95% CI, 8.8-16.0). In patients with ccRCC, ORR was 24.4%, PFS was 7.1 months (95% CI, 5.0-10.5), and OS was 11.7 months (95% CI, 7.9-16.1). 50.9% of patients required dose reductions and 7.3% discontinued treatment because of toxicity.
Len +/- Eve demonstrated meaningful clinical activity and tolerability in heavily pre-treated patients with mRCC after disease progression with prior ICI and VEGFR-TKI.

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