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

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