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

Matteo Santoni; Francesco Massari; Zin W. Myint; Roberto Iacovelli; Martin Pichler; Umberto Basso; Jindrich Kopecky; Jakub Kucharz; Sebastiano Buti; Mimma Rizzo; Luca Galli; Thomas Büttner; Ugo De Giorgi; Ravindran Kanesvaran; Ondřej Fiala; Enrique Grande; Paolo Andrea Zucali; Giuseppe Fornarini; Maria T. Bourlon; Sarah Scagliarini; Javier Molina-Cerrillo; Gaetano Aurilio; Marc R. Matrana; Renate Pichler; Carlo Cattrini; Tomas Büchler; Emmanuel Seront; Fabio Calabrò; Alvaro Pinto; Rossana Berardi; Anca Zgura; Giulia Mammone; Jawaher Ansari; Francesco Atzori; Rita Chiari; Aristotelis Bamias; 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; Ignacio Ortego Zabalza; Alessandro Rizzo; Veronica Mollica; Giulia Sorgentoni; Fernando Sabino M. Monteiro; Rodolfo Montironi; Nicola Battelli; Camillo Porta

doi:10.1007/s11523-023-00978-2

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

Matteo Santoni, Francesco Massari, Zin W. Myint, Roberto Iacovelli, Martin Pichler, Umberto Basso, Jindrich Kopecky, Jakub Kucharz, Sebastiano Buti, Mimma Rizzo, Luca Galli, Thomas Büttner, Ugo De Giorgi, Ravindran Kanesvaran, Ondřej Fiala, Enrique Grande, Paolo Andrea Zucali, Giuseppe Fornarini, Maria T. Bourlon, Sarah ScagliariniJavier Molina-Cerrillo, Gaetano Aurilio, Marc R. Matrana, Renate Pichler, Carlo Cattrini, Tomas Büchler, Emmanuel Seront, Fabio Calabrò, Alvaro Pinto, Rossana Berardi, Anca Zgura, Giulia Mammone, Jawaher Ansari, Francesco Atzori, Rita Chiari, Aristotelis Bamias, 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, Ignacio Ortego Zabalza, Alessandro Rizzo, Veronica Mollica, Giulia Sorgentoni, Fernando Sabino M. Monteiro, Rodolfo Montironi, Nicola Battelli, Camillo Porta

Research output: Contribution to journal › Article › peer-review

31 Scopus citations

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.

Original language	English
Pages (from-to)	559-570
Number of pages	12
Journal	Targeted Oncology
Volume	18
Issue number	4
DOIs	https://doi.org/10.1007/s11523-023-00978-2
State	Published - Jul 2023

Bibliographical note

Publisher Copyright:
© 2023, The Author(s), under exclusive licence to Springer Nature Switzerland AG.

Funding

None to declare.

ASJC Scopus subject areas

Oncology
Pharmacology (medical)
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s11523-023-00978-2

Cite this

Santoni, M., Massari, F., Myint, Z. W., Iacovelli, R., Pichler, M., Basso, U., Kopecky, J., Kucharz, J., Buti, S., Rizzo, M., Galli, L., Büttner, T., De Giorgi, U., Kanesvaran, R., Fiala, O., Grande, E., Zucali, P. A., Fornarini, G., Bourlon, M. T., ... Porta, C. (2023). Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study. Targeted Oncology, 18(4), 559-570. https://doi.org/10.1007/s11523-023-00978-2

@article{692c497f54404aaa9d46b15f53dc48a7,

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

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.",

author = "Matteo Santoni and Francesco Massari and Myint, \{Zin W.\} and Roberto Iacovelli and Martin Pichler and Umberto Basso and Jindrich Kopecky and Jakub Kucharz and Sebastiano Buti and Mimma Rizzo and Luca Galli and Thomas B{\"u}ttner and \{De Giorgi\}, Ugo and Ravindran Kanesvaran and Ond{\v r}ej Fiala and Enrique Grande and Zucali, \{Paolo Andrea\} and Giuseppe Fornarini and Bourlon, \{Maria T.\} and Sarah Scagliarini and Javier Molina-Cerrillo and Gaetano Aurilio and Matrana, \{Marc R.\} and Renate Pichler and Carlo Cattrini and Tomas B{\"u}chler and Emmanuel Seront and Fabio Calabr{\`o} and Alvaro Pinto and Rossana Berardi and Anca Zgura and Giulia Mammone and Jawaher Ansari and Francesco Atzori and Rita Chiari and Aristotelis Bamias and Orazio Caffo and Giuseppe Procopio and Maria Bassanelli and Sara Merler and Carlo Messina and Zs{\'o}fia K{\"u}ronya and Alessandra Mosca and Dipen Bhuva and Nuno Vau and Lorena Incorvaia and Rebuzzi, \{Sara Elena\} and Giandomenico Roviello and Zabalza, \{Ignacio Ortego\} and Alessandro Rizzo and Veronica Mollica and Giulia Sorgentoni and Monteiro, \{Fernando Sabino M.\} and Rodolfo Montironi and Nicola Battelli and Camillo Porta",

note = "Publisher Copyright: {\textcopyright} 2023, The Author(s), under exclusive licence to Springer Nature Switzerland AG.",

year = "2023",

month = jul,

doi = "10.1007/s11523-023-00978-2",

language = "English",

volume = "18",

pages = "559--570",

journal = "Targeted Oncology",

issn = "1776-2596",

publisher = "Adis",

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Santoni, M, Massari, F, Myint, ZW, Iacovelli, R, Pichler, M, Basso, U, Kopecky, J, Kucharz, J, Buti, S, Rizzo, M, Galli, L, Büttner, T, De Giorgi, U, Kanesvaran, R, Fiala, O, Grande, E, Zucali, PA, Fornarini, G, Bourlon, MT, Scagliarini, S, Molina-Cerrillo, J, Aurilio, G, Matrana, MR, Pichler, R, Cattrini, C, Büchler, T, Seront, E, Calabrò, F, Pinto, A, Berardi, R, Zgura, A, Mammone, G, Ansari, J, Atzori, F, Chiari, R, Bamias, A, Caffo, O, Procopio, G, Bassanelli, M, Merler, S, Messina, C, Küronya, Z, Mosca, A, Bhuva, D, Vau, N, Incorvaia, L, Rebuzzi, SE, Roviello, G, Zabalza, IO, Rizzo, A, Mollica, V, Sorgentoni, G, Monteiro, FSM, Montironi, R, Battelli, N & Porta, C 2023, 'Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma: The ARON-1 Study', Targeted Oncology, vol. 18, no. 4, pp. 559-570. https://doi.org/10.1007/s11523-023-00978-2

TY - JOUR

T1 - Global Real-World Outcomes of Patients Receiving Immuno-Oncology Combinations for Advanced Renal Cell Carcinoma

T2 - The ARON-1 Study

AU - Santoni, Matteo

AU - Massari, Francesco

AU - Myint, Zin W.

AU - Iacovelli, Roberto

AU - Pichler, Martin

AU - Basso, Umberto

AU - Kopecky, Jindrich

AU - Kucharz, Jakub

AU - Buti, Sebastiano

AU - Rizzo, Mimma

AU - Galli, Luca

AU - Büttner, Thomas

AU - De Giorgi, Ugo

AU - Kanesvaran, Ravindran

AU - Fiala, Ondřej

AU - Grande, Enrique

AU - Zucali, Paolo Andrea

AU - Fornarini, Giuseppe

AU - Bourlon, Maria T.

AU - Scagliarini, Sarah

AU - Molina-Cerrillo, Javier

AU - Aurilio, Gaetano

AU - Matrana, Marc R.

AU - Pichler, Renate

AU - Cattrini, Carlo

AU - Büchler, Tomas

AU - Seront, Emmanuel

AU - Calabrò, Fabio

AU - Pinto, Alvaro

AU - Berardi, Rossana

AU - Zgura, Anca

AU - Mammone, Giulia

AU - Ansari, Jawaher

AU - Atzori, Francesco

AU - Chiari, Rita

AU - Bamias, Aristotelis

AU - Caffo, Orazio

AU - Procopio, Giuseppe

AU - Bassanelli, Maria

AU - Merler, Sara

AU - Messina, Carlo

AU - Küronya, Zsófia

AU - Mosca, Alessandra

AU - Bhuva, Dipen

AU - Vau, Nuno

AU - Incorvaia, Lorena

AU - Rebuzzi, Sara Elena

AU - Roviello, Giandomenico

AU - Zabalza, Ignacio Ortego

AU - Rizzo, Alessandro

AU - Mollica, Veronica

AU - Sorgentoni, Giulia

AU - Monteiro, Fernando Sabino M.

AU - Montironi, Rodolfo

AU - Battelli, Nicola

AU - Porta, Camillo

PY - 2023/7

Y1 - 2023/7

N2 - 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.

AB - 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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U2 - 10.1007/s11523-023-00978-2

DO - 10.1007/s11523-023-00978-2

M3 - Article

C2 - 37369815

AN - SCOPUS:85163298625

SN - 1776-2596

VL - 18

SP - 559

EP - 570

JO - Targeted Oncology

JF - Targeted Oncology

IS - 4

ER -

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

Abstract

Bibliographical note

Funding

ASJC Scopus subject areas

UN SDGs

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