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.
The oncologist. 2021 Mar 31 [Epub ahead of print]
Andrew J Wiele, Tharakeswara K Bathala, Andrew W Hahn, Lianchun Xiao, Munavver Duran, Jeremy A Ross, Eric Jonasch, Amishi Y Shah, Matthew T Campbell, Pavlos Msaouel, Nizar M Tannir
Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX., Department of Abdominal Imaging, Division of Diagnostic Imaging, University of Texas MD Anderson Cancer Center, Houston, TX., Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX., Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX.