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This study aimed to compare the real-world effectiveness of ICI-ICI versus ICI-TKI combinations in patients with intermediate- and poor-risk mRCC according to International Metastatic RCC Database Consortium (IMDC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The Meet-URO 33 study is a multicentre retrospective-prospective registry collecting real-world data on patients with mRCC. Multivariable logistic and Cox models were built for objective response rate (ORR), PFS and OS, with a propensity score (PS) adjustment for baseline imbalances.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 1497 patients, 755 were intermediate-risk (199 ICI-ICI, 556 ICI-TKI) and 312 poor-risk (77 ICI-ICI, 212 ICI-TKI). Median follow-up was 14.2\u00a0months (8.0\u00a0months and 14.5\u00a0months in poor- and intermediate-risk subgroups, respectively). In poor-risk patients, median OS was 20.3 versus 12.9\u00a0months (HR 0.87, 95% CI 0.59\u20131.28,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.49), and median PFS was 6.7 versus 8.7\u00a0months (HR 1.10, 95% CI 0.79\u20131.54,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.53), for ICI-ICI versus ICI\u2013TKI, respectively. In the intermediate-risk patients treated with ICI-ICI versus ICI-TKI, median OS was 37.8 versus 35.5\u00a0months (HR 1.08; 95% CI 0.77\u20131.50;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.65), and median PFS was 17.8 versus 18.6\u00a0months (HR 1.29, 95% CI 1.00\u20131.66,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.050). ORR was 42.9% versus 45.8% in poor-risk patients (OR 0.72, 95% CI 0.39\u20131.34,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.303) and 48.1% versus 54.3% in intermediate-risk patients (OR 0.71, 95% CI 0.48\u20131.04,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.075).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>No statistically significant differences in survival or response were observed between ICI-ICI and ICI-TKI combinations in patients with IMDC intermediate- and poor-risk mRCC.<\/jats:p>\n                  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G Fornarini services advisory boards for Astellas, Janssen, Pfizer, Bayer, MSD, and Merck, and received travel accommodations from Astellas, Janssen, and Bay er. S Buti received honoraria as a speaker at scientific events and in an advisory role by BMS, Pfizer, MSD, Ipsen, Roche, Eli Lilly, AstraZeneca, Pierre-Fabre, Novartis, Mer ck, Gentili, and Astellas. GL Banna reports personal fees from AstraZeneca and Astellas for speakers bureaus. P Rescigno services advisory boards for MSD, AstraZeneca, and Janssen. C Masini received personal fees as a speaker from Astellas; as a consultant from Ipsen, MSD, and Janssen; and for travel accommodations from Bristol-Myers Squibb, Pfizer, Astellas, Janssen, and Ipsen. The other authors declare they have no conflicts of interest to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The authors state that they have obtained appropriate institutional review board approval. The study protocol was approved by the Ethics Committee of Istituto Oncologico Veneto IOV IRCCS of Padua on 1st June 2023 (Registration number: CESC IOV 2023-78). Documented approval from the Local Ethics Committee of each participating centre was required before study activation at each site. The Authors have follow ed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations in volving human subjects, informed consent has been obtained from all the participants involved.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}],"article-number":"66"}}