Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study.
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Santoni Matteo, Massari Francesco, Myint Zin W, Iacovelli Roberto, Pichler Martin, Basso Umberto, Kopecky Jindrich, Kucharz Jakub, Buti Sebastiano, Rizzo Mimma, Galli Luca, Büttner Thomas, De Giorgi Ugo, Kanesvaran Ravindran, Fiala Ondřej, Grande Enrique, Zucali Paolo Andrea, Fornarini Giuseppe, Bourlon Maria T, Scagliarini Sarah, Molina-Cerrillo Javier, Aurilio Gaetano, Matrana Marc R, Pichler Renate, Cattrini Carlo, Büchler Tomas, Seront Emmanuel, Calabrò Fabio, Pinto Alvaro, Berardi Rossana, Zgura Anca, Mammone Giulia, Ansari Jawaher, Atzori Francesco, Chiari Rita, Bamias Aristotelis, Caffo Orazio, Procopio Giuseppe, Bassanelli Maria, Merler Sara, Messina Carlo, Küronya Zsófia, Mosca Alessandra, Bhuva Dipen, Vau Nuno, Incorvaia Lorena, Rebuzzi Sara Elena, Roviello Giandomenico, Zabalza Ignacio Ortego, Rizzo Alessandro, Mollica Veronica, Sorgentoni Giulia, Monteiro Fernando Sabino M, Montironi Rodolfo, Battelli Nicola, Porta Camillo
Аннотация
OBJECTIVE: The ARON-1 study (NCT05287464) was designed to globally collect real-world data on the use of immuno-combinations as first-line therapy for mRCC patients.
PATIENTS AND METHODS: Patients aged ≥ 18 years with a cytologically and/or histologically confirmed diagnosis of mRCC treated with first-line immuno-combination therapies were retrospectively included from 47 International Institutions from 16 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall clinical benefit (OCB).
RESULTS: A total of 729 patients were included; tumor histology was clear-cell RCC in 86% of cases; 313 patients received dual immuno-oncology (IO + IO) therapy while 416 were treated with IO-tyrosine kinase inhibitor (IO + TKI) combinations. In the overall study population, the median OS and PFS were 36.5 and 15.0 months, respectively. The median OS was longer with IO+TKI compared with IO+IO therapy in the 616 patients with intermediate/poor International mRCC Database Consortium (IMDC) risk criteria (55.7 vs 29.7 months; p = 0.045). OCB was 84% for IO+TKI and 72% for IO + IO combination (p < 0.001).
CONCLUSIONS: Our study may suggest that immuno-oncology combinations are effective as first-line therapy in the mRCC real-world context, showing outcome differences between IO + IO and IO + TKI combinations in mRCC subpopulations.
CLINICAL TRIAL REGISTRATION: NCT05287464.