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Immune-based Combinations in Intermediate-/Poor-risk Patients with Non-clear Cell Renal Cell Carcinoma: Results from

Francesco Massari1, Veronica Mollica2, Ray Manneh Kopp3

  • 1Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.

European Urology Focus
|July 30, 2025
PubMed
Abstract

Insights

Immune checkpoint inhibitor/tyrosine kinase inhibitor combinations show superior efficacy for non-clear cell renal cell carcinoma (nccRCC). Pembrolizumab/lenvatinib demonstrated significant benefits in patients with intermediate-/poor-risk nccRCC.

Area of Science:

  • Oncology
  • Immunotherapy
  • Renal Cell Carcinoma Research

Background:

  • Non-clear cell renal cell carcinoma (nccRCC) treatment lacks direct comparisons of immune-based combinations.
  • An unmet need exists for defining optimal first-line therapies for intermediate-/poor-risk nccRCC patients.

Purpose of the Study:

  • To assess the real-world efficacy of first-line immune-based combinations in metastatic nccRCC.
  • To compare different immune checkpoint inhibitor (ICI) plus tyrosine kinase inhibitor (TKI) regimens.

Main Methods:

  • Retrospective, multicenter study of 323 metastatic nccRCC patients across 56 centers in 17 countries.
  • Patients received first-line pembrolizumab/lenvatinib, pembrolizumab/axitinib, nivolumab/cabozantinib, or nivolumab/ipilimumab.
  • Primary endpoints: overall survival (OS), progression-free survival (PFS), and overall response rate (ORR).

Main Results:

  • Median OS was 31.1 months; 2-year OS rate was 58%.
  • Overall response rate (ORR) was 38%, with a median PFS of 13.0 months.
  • ICI/TKI combinations significantly outperformed ICI doublets, with pembrolizumab/lenvatinib showing notable benefits.

Conclusions:

  • ICI/TKI combinations represent an optimal strategy for intermediate-/poor-risk nccRCC.
  • Pembrolizumab/lenvatinib demonstrated marked benefits in this patient population.
  • Further research is warranted to validate these real-world findings.
Keywords:
ARON-1Immune checkpoint inhibitorsImmune-based combinationsKidney cancerNon–clear cell renal cell carcinomaTyrosine kinase inhibitors

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