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Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study

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Abstract

Background

Immuno-oncology combinations have achieved survival benefits in patients with metastatic renal cell carcinoma (mRCC).

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.

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Acknowledgements

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Authors and Affiliations

Authors

Corresponding author

Correspondence to Matteo Santoni.

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Conflict of interest

Matteo Santoni has received research support and honoraria from Janssen, Bristol Myers Squibb, Ipsen, MSD, Astellas, and Bayer, all unrelated to the present paper. R. Kanesvaran has received fees for speaker bureau and advisory board activities from the following companies: Pfizer, MSD, BMS, Eisai, Ipsen, Johnson and Johnson, Merck, Amgen, Astellas, and Bayer. Enrique Grande has received honoraria for speaker engagements, advisory roles or funding of continuous medical education from Adacap, AMGEN, Angelini, Astellas, Astra Zeneca, Bayer, Blueprint, Bristol Myers Squibb, Caris Life Sciences, Celgene, Clovis-Oncology, Eisai, Eusa Pharma, Genetracer, Guardant Health, HRA-Pharma, IPSEN, ITM-Radiopharma, Janssen, Lexicon, Lilly, Merck KGaA, MSD, Nanostring Technologies, Natera, Novartis, ONCODNA (Biosequence), Palex, Pharmamar, Pierre Fabre, Pfizer, Roche, Sanofi-Genzyme, Servier, Taiho, and Thermo Fisher Scientific. EG has received research grants from Pfizer, Astra Zeneca, Astellas, and Lexicon Pharmaceuticals. Tomas Buchler has received research support and honoraria from Roche, Bristol Myers Squibb, Ipsen, Exelixis, Eisai, Merck Sharp Dohme, Merck, Eli Lilly, and AstraZeneca, all unrelated to the present paper. Aristotelis Bamias has received honoraria/advisory/research support by Pfizer, BMS, AZ, MSD, Roche, Janssen, Ipsen, Bayer, and Merck. Fernando Sabino Marques Monteiro has received research support from Janssen and Merck Sharp Dome and honoraria from Janssen, Ipsen, Bristol Myers Squibb, and Merck Sharp Dome. Camillo Porta has received honoraria from Angelini Pharma, AstraZeneca, BMS, Eisai, General Electric, Ipsen, and MSD and acted as a Protocol Steering Committee Member for BMS, Eisai, and MSD. The other authors declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.

Funding

No external funding was used in the preparation of this manuscript.

Ethics approval, Consent to Participate

This retrospective research was carried out in accordance with the approval from the ethics committee of the Marche Region (2021-492) and was performed in accordance with the Declaration of Helsinki.

Availability of data

All data generated or analyzed during this study are included in this published article (and its supplementary information files). The datasets generated during and/or analyzed during the current study are not publicly available in accordance with all the centers participating to the ARON project but are available from the corresponding author on reasonable request.

Author contributions

Conceptualization: Matteo Santoni, Camillo Porta, Gaetano Aurilio. Data curation: Matteo Santoni, Francesco Massari, Fernando Sabino M. Monteiro, Zin W. Myint, Umberto Basso, Jindrich Kopecky, Jakub Kucharz, Mimma Rizzo1 Luca Galli, Thomas Büttner, Ugo De Giorgi, Ondřej Fiala, Paolo Andrea Zucali, Giuseppe Fornarini, Maria T Bourlon, Sarah Scagliarini, Javier Molina-Cerrillo, Marc R Matrana, Renate Pichler, Carlo Cattrini, Emmanuel Seront, Alvaro Pinto, Rossana Berardi, Anca Zgura, Giulia Mammone, Jawaher Ansari, Francesco Atzori, Rita Chiari, Orazio Caffo, Giuseppe Procopio, Maria Bassanelli, Sara Merler, Carlo Messina, Zsófia Küronya, Alessandra Mosca, Dipen Bhuva, Nuno Vau, Lorena Incorvaia, Sara Elena Rebuzzi, Giandomenico Roviello. Formal analysis: Matteo Santoni. Investigation: Francesco Massari. Methodology: Alessandro Rizzo, Ignacio Ortego Zabalza, Roberto Iacovelli, Martin Pichler. Project administration: Giulia Sorgentoni. Supervision: Enrique Grande, Aristotelis Bamias, Fabio Calabrò. Roles/writing—original draft: Matteo Santoni, Veronica Mollica, Sebastiano Buti. Writing—review & editing: Tomas Büchler, Ravindran Kanesvaran, Camillo Porta, Nicola Battelli, Rodolfo Montironi.

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Santoni, M., Massari, F., Myint, Z.W. et al. Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study. Targ Oncol 18, 559–570 (2023). https://doi.org/10.1007/s11523-023-00978-2

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