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Observational Study
. 2025 Jun;21(15):1895-1904.
doi: 10.1080/14796694.2025.2508138. Epub 2025 May 20.

Real-world efficacy and safety of nivolumab and ipilimumab in metastatic renal cell carcinoma: a Polish multicenter study

Renata Pacholczak-Madej  1   2   3 , Artur Drobniak  1 , Łukasz Stokłosa  1   4 , Aleksandra Grela-Wojewoda  5 , Jacek Calik  6 , Natalia Versuti Viegas  6 , Daria Tusień-Małecka  7 , Marek Szwiec  8 , Jolanta Dobrzańska  9   10 , Agnieszka Roman  11 , Anna Bidas  12 , Angelika Gawlik-Urban  2   13   14 , Jerzy Walocha  3 , Paweł Blecharz  2 , Mirosława Puskulluoglu  5
Affiliations
Observational Study

Real-world efficacy and safety of nivolumab and ipilimumab in metastatic renal cell carcinoma: a Polish multicenter study

Renata Pacholczak-Madej et al. Future Oncol. 2025 Jun.

Abstract

Background: Nivolumab plus ipilimumab (NIVO+IPI) is a first-line treatment for metastatic renal cell carcinoma (mRCC) in intermediate- and poor-risk patients. Real-world evidence (RWE) studies are needed to validate its efficacy and safety in clinical practice.

Methods: This multicenter retrospective study included 145 mRCC patients treated with NIVO+IPI at nine oncology centers in Poland between May 2022 and December 2024. Data on overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and immune-related adverseevents (irAEs) were analyzed using Kaplan-Meier survival estimates and Cox proportional hazards models, with p-value <0.05 considered statistically significant.

Results: With a limited median follow-up of 10.9 months, median PFS was 12.8 months (95% CI:7.0-18.6), and median OS was not reached. ORR and DCR were 34.5% and 66.2%,respectively. In intermediate-risk patients, ORR and DCR were higher than in poor-risk patients without statistical significance. IrAEs occurred in 61.4% of patients, with grade 3/4 irAEs in 25.5%. Karnofsky Performance Status < 80%, central nervous system metastases, and hepatic irAEs were associated with poorer survival in a multivariate analysis (p = 0.002).

Conclusions: This study confirms the real-world efficacy and safety of NIVO+IPI in mRCC, demonstrating outcomes comparable to clinical trials.

Keywords: Nivolumab and ipilimumab; adverse events; immunotherapy; real-world evidence; renal cell carcinoma.

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Conflict of interest statement

RPM has received travel grants from Accord, BMS, MSD, Gilead and lecture fees from Astra Zeneca, BMS, GSK, Novartis, Roche, MSD;.

AD has received travel grants and lecture fees from Roche, BMS, Janssen, Molteni, MSD, Accord;

ŁS has received travel grants from BMS, Accord;

AGW has received travel grants and lecture fees from Roche, Novartis, Lili, Astellas, Pfizer, Amgen, Swixx, Pierre Fabre, Egis, BMS, MSD;

JC has received lecture fees from BMS;

NVV has no financial interests;

DTM has received travel grants and lecture fees from MSD, Pierre Fabre, BMS, Novartis, Pfizer;

MS has received travel grants and lecture fees from Roche, BMS, Janssen, MSD, Amgen, Astellas, Ipsen, Pfizer, Novartis, Gilead;

JD has received travel grants and lecture fees from Amgen, AstraZeneca, BMS, MSD, Novartis, Nutricia;

AR has received travel grants and lecture fees from Roche, BMS, Ipsen, Pfizer, Novartis, Gilead, MSD;

AB has received travel grants and lecture fees from BMS, MSD, Astellas, Merck, Servier, Astra Zeneca, Pfizer;

JW has no financial interests;

PB has received travel grants, lecture fees, and advisory boards from AstraZeneca, MSD, GSK, Pharma;

MP has received travel grants and lecture fees from AstraZeneca, Roche, Novartis, Elli Lilly, Janssen, Gilead and Amgen;

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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References

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    2. •• This pivotal trial established the role of NIVO+IPI in first-line treatment of mRCC and serves as the key benchmark for real-world comparisons.

    1. Tannir NM, Escudier B, McDermott DF, et al. Nivolumab plus ipilimumab (NIVO+IPI) vs sunitinib (SUN) for first-line treatment of advanced renal cell carcinoma (aRCC): long-term follow-up data from the phase 3 CheckMate 214 trial. J Clin Oncol. 2024;42(4_suppl):363. doi: 10.1200/JCO.2024.42.4_suppl.363 - DOI
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    2. • A comparable retrospective multicenter real-world study providing international context to our findings.

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