Background: Immune checkpoint inhibitor doublet (ICI-ICI) and ICI plus tyrosine kinase inhibitor (ICI-TKI) regimens are the cornerstone of treatment for metastatic renal cell carcinoma (mRCC), although no head-to-head comparisons are currently available. 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). Methods: 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. Results: 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 months (8.0 months and 14.5 months in poor- and intermediate-risk subgroups, respectively). In poor-risk patients, median OS was 20.3 versus 12.9 months (HR 0.87, 95% CI 0.59–1.28, p = 0.49), and median PFS was 6.7 versus 8.7 months (HR 1.10, 95% CI 0.79–1.54, p = 0.53), for ICI-ICI versus ICI–TKI, respectively. In the intermediate-risk patients treated with ICI-ICI versus ICI-TKI, median OS was 37.8 versus 35.5 months (HR 1.08; 95% CI 0.77–1.50; p = 0.65), and median PFS was 17.8 versus 18.6 months (HR 1.29, 95% CI 1.00–1.66, p = 0.050). ORR was 42.9% versus 45.8% in poor-risk patients (OR 0.72, 95% CI 0.39–1.34, p = 0.303) and 48.1% versus 54.3% in intermediate-risk patients (OR 0.71, 95% CI 0.48–1.04, p = 0.075). Conclusions: 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.
Effectiveness of ICI-ICI versus ICI-TKI combinations in patients with IMDC intermediate- and poor-risk metastatic renal cell carcinoma: a sub-analysis of the MEET-URO 33 study / Maffezzoli, Michele; Signori, Alessio; Acunzo, Alessandro; Buti, Sebastiano; Bosoni, Michela; Verzoni, Elena; Di Marco, Andrea; Lolli, Cristian; Di Napoli, Marilena; Fanelli, Martina; Volta, Alberto Dalla; Masini, Cristina; Roviello, Giandomenico; Iacovelli, Roberto; Mennitto, Alessia; Filippi, Roberto; Sorarù, Mariella; Formisano, Luigi; Guida, Annalisa; Fantinel, Emanuela; Messina, Carlo; Bonomi, Lucia; Scagliarini, Sarah; Nasso, Cecilia; Chiellino, Silvia; Maiorano, Brigida Anna; Deppieri, Filippo; Cavo, Alessia; Conteduca, Vincenza; Zai, Silvia; Zucali, Paolo Andrea; Tucci, Marcello; Vignani, Francesca; La Russa, Francesca; Lombardo, Laura; Caserta, Claudia; Paolieri, Federico; Bertolotti, Francesca; Rescigno, Pasquale; Banna, Giuseppe Luigi; Fornarini, Giuseppe; Bimbatti, Davide; Rebuzzi, Sara Elena. - In: CANCER IMMUNOLOGY, IMMUNOTHERAPY. - ISSN 1432-0851. - 75:3(2026). [10.1007/s00262-026-04318-x]
Effectiveness of ICI-ICI versus ICI-TKI combinations in patients with IMDC intermediate- and poor-risk metastatic renal cell carcinoma: a sub-analysis of the MEET-URO 33 study
Maffezzoli, MicheleWriting – Original Draft Preparation
;Acunzo, AlessandroInvestigation
;Buti, Sebastiano
Conceptualization
;
2026-01-01
Abstract
Background: Immune checkpoint inhibitor doublet (ICI-ICI) and ICI plus tyrosine kinase inhibitor (ICI-TKI) regimens are the cornerstone of treatment for metastatic renal cell carcinoma (mRCC), although no head-to-head comparisons are currently available. 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). Methods: 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. Results: 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 months (8.0 months and 14.5 months in poor- and intermediate-risk subgroups, respectively). In poor-risk patients, median OS was 20.3 versus 12.9 months (HR 0.87, 95% CI 0.59–1.28, p = 0.49), and median PFS was 6.7 versus 8.7 months (HR 1.10, 95% CI 0.79–1.54, p = 0.53), for ICI-ICI versus ICI–TKI, respectively. In the intermediate-risk patients treated with ICI-ICI versus ICI-TKI, median OS was 37.8 versus 35.5 months (HR 1.08; 95% CI 0.77–1.50; p = 0.65), and median PFS was 17.8 versus 18.6 months (HR 1.29, 95% CI 1.00–1.66, p = 0.050). ORR was 42.9% versus 45.8% in poor-risk patients (OR 0.72, 95% CI 0.39–1.34, p = 0.303) and 48.1% versus 54.3% in intermediate-risk patients (OR 0.71, 95% CI 0.48–1.04, p = 0.075). Conclusions: 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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
