Real‐world efficacy and toxicity of ipilimumab and nivolumab as a first‐line treatment for advanced renal cell carcinoma according to <scp>IMDC</scp> risk criteria—A multi‐center retrospective analysis on behalf of the <scp>GUARDIANS</scp> group

Ipilimumab and nivolumab are recommended as first-line therapy for patients with metastatic or advanced renal cell carcinoma (aRCC) and International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk. We retrospectively evaluated efficacy and safety in a multi-center real-world cohort with 356 patients initiating ipilimumab and nivolumab from 17 centers in Germany and Switzerland. Median age was 64 years, most patients were male (69.1%) and had clear cell histology (74.1%). IMDC risk was intermediate in 61.8% and poor in 28.7%. About 37.1% of cases did not meet the inclusion criteria for the CheckMate 214 pivotal study (e.g., poor Eastern Cooperative Oncology Group [Performance Status Scale] [ECOG] status, comorbidities, brain metastases, and impaired renal function). After a median follow-up of 17.5 months, complete response was seen in 8.7%, partial response in 28.7% of patients. Median progression-free survival (PFS) was 8 (95% confidence interval [CI] 5.4-10.6) and median overall survival (OS) 39 months (95% CI 27.5-50.5). Subgroup analysis of patients with non-clear cell histology showed a shorter PFS and OS. Other negative predictors were poor ECOG, fewer induction cycles, ineligibility to pivotal study, and hepatic metastases. Adverse events occurred in 76.4% of patients (35.4% ≥ grade 3). High-dose corticosteroids were applied in 27.3% of cases. Cabozantinib was most frequently administered (63.4%) as subsequent therapy and showed superior OS and PFS compared to other second-line options. Our data support ipilimumab and nivolumab as a first-line treatment of aRCC with robust efficacy and safety. Patient selection was less restrictive in our clinical practice and may explain differences to CheckMate 214 trial.

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Publication Details

Journal
International Journal of Cancer
Published
2025-11-29
DOI
https://doi.org/10.1002/ijc.70267
Primary Topic
Renal cell carcinoma treatment
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article
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article

Real‐world efficacy and toxicity of ipilimumab and nivolumab as a first‐line treatment for advanced renal cell carcinoma according to IMDC risk criteria—A multi‐center retrospective analysis on behalf of the GUARDIANS group

Viktor Grünwald, Timo Egenolf, Christopher Goßler, Can Aydogdu et al.
International Journal of Cancer
Renal cell carcinoma treatment
article

Real‐world efficacy and toxicity of ipilimumab and nivolumab as a first‐line treatment for advanced renal cell carcinoma according to IMDC risk criteria—A multi‐center retrospective analysis on behalf of the GUARDIANS group

Viktor Grünwald, Timo Egenolf, Christopher Goßler, Can Aydogdu, Marc Rehlinghaus, Arne Strauß, Philipp Ivanyi, Linus Materna, Stefanie Zschäbitz, Hendrik Dinkel, Katrin Schlack, S. Neuberger, Marit Ahrens, Richard Cathomas, Jozefina Casuscelli, Pia Paffenholz, Thomas Hilser, Julie Steinestel, Berna C. Özdemir, Ramona Stelmach, Florian Kirchhoff, Matteo Silberg
article en

Abstract

Ipilimumab and nivolumab are recommended as first-line therapy for patients with metastatic or advanced renal cell carcinoma (aRCC) and International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk. We retrospectively evaluated efficacy and safety in a multi-center real-world cohort with 356 patients initiating ipilimumab and nivolumab from 17 centers in Germany and Switzerland. Median age was 64 years, most patients were male (69.1%) and had clear cell histology (74.1%). IMDC risk was intermediate in 61.8% and poor in 28.7%. About 37.1% of cases did not meet the inclusion criteria for the CheckMate 214 pivotal study (e.g., poor Eastern Cooperative Oncology Group [Performance Status Scale] [ECOG] status, comorbidities, brain metastases, and impaired renal function). After a median follow-up of 17.5 months, complete response was seen in 8.7%, partial response in 28.7% of patients. Median progression-free survival (PFS) was 8 (95% confidence interval [CI] 5.4-10.6) and median overall survival (OS) 39 months (95% CI 27.5-50.5). Subgroup analysis of patients with non-clear cell histology showed a shorter PFS and OS. Other negative predictors were poor ECOG, fewer induction cycles, ineligibility to pivotal study, and hepatic metastases. Adverse events occurred in 76.4% of patients (35.4% ≥ grade 3). High-dose corticosteroids were applied in 27.3% of cases. Cabozantinib was most frequently administered (63.4%) as subsequent therapy and showed superior OS and PFS compared to other second-line options. Our data support ipilimumab and nivolumab as a first-line treatment of aRCC with robust efficacy and safety. Patient selection was less restrictive in our clinical practice and may explain differences to CheckMate 214 trial.

International Journal of CancerVol. 158(9)
Goethe University Frankfurt (DE), University of Cologne (DE), Johannes Gutenberg University Mainz (DE), Heidelberg University (DE), University Hospital of Bern (CH), University Hospital Augsburg (DE), University Hospital Heidelberg (DE), TUM Klinikum (DE), Medizinische Hochschule Hannover (DE), Universitätsklinik Marien Hospital Herne (DE), Düsseldorf University Hospital (DE), University Medical Center of the Johannes Gutenberg University Mainz (DE), Integrated Oncology (United States) (US), German Cancer Society (DE), University Hospital Münster (DE), National Center for Tumor Diseases (DE), Universitätsmedizin Göttingen (DE), Essen University Hospital (DE), Universitätsklinikum Würzburg (DE), University Hospital Frankfurt (DE), Kantonsspital Graubünden (CH), University Hospital Cologne (DE), Caritas-Krankenhaus St. Josef (DE), West German Heart and Vascular Center Essen (DE), Heinrich Heine University Düsseldorf (DE), University of Regensburg (DE), University of Duisburg-Essen (DE), University of Göttingen (DE), Ludwig-Maximilians-Universität München (DE), Ruhr University Bochum (DE)
Openalex Percentile: Top 44%
Renal cell carcinoma treatment
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