Pembrolizumab-axitinib versus nivolumab-cabozantinib as first-line therapy in patients with metastatic renal cell carcinoma: a retrospective real-world comparison (ARON-1)
(2025) Cancer Immunology, Immunotherapy — Vol. 74, n° 7, p. 225 (2025)
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- Background The optimal first-line therapy for metastatic renal cell carcinoma (mRCC) remains uncertain, despite recent advancements in immune-based combinations. This retrospective study compares the effectiveness of pembrolizumab plus axitinib (PA) and nivolumab plus cabozantinib (NC) as first-line treatments for mRCC in a real-world setting. Methods Patient data were collected from 55 centers across 16 countries, encompassing individuals diagnosed with mRCC receiving first-line treatment with PA or NC between January 2016 and October 2023. Clinical and tumor features and treatment responses were recorded. The primary endpoints were overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and time to second progression. Statistical analyses included Kaplan-Meier survival estimates, Cox proportional hazard models, and chi-square tests. Results A total of 760 patients with a median age of 64 years (range, 29-88) were included. Of them, 607 received PA, and only 153 NC. In the overall study population, ORR was 59% for and 49% for PA. Median OS was 55.7 months and not reached (NR) for PA and NC, respectively (P = .51), while median PFS was longer with NC (27.6 months) than for PA (16.2 months, P = .003). Subgroup analysis suggested a PFS benefits for NC in male, younger patients, intermediate risk group, clear cell histology, and lung involvement, as well as ORR favored NC in good risk patients. Multivariate analysis identified first-line therapy as a significant factor associated with PFS. Conclusions In this certainly biased retrospective comparison, NC demonstrated superior ORR and longer PFS compared to PA in mRCC. These findings underscore the importance of considering individual patient characteristics and risk profiles when selecting first-line therapy for mRCC.
- Affiliations
Macerata Hospital, Macerata, Italy Oncology Unit University of Florence, Viale Pieraccini 6, 50139 Florence, Italy Department of Health Sciences, Section of Clinical Pharmacology and Oncology MD Anderson Cancer Center Madrid, Madrid, Spain Department of Medical Oncology IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) “Dino Amadori”, Meldola, Italy Department of Medical Oncology Charles University, Pilsen, Czech Republic Department of Oncology and Radiotherapeutics, Faculty of Medicine and University Hospital in Pilsen Madrid, Spain Hospital Ramón y Cajal Medical University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria Department of Urology University of Kentucky, Lexington, KY 40536‑0293, USA Markey Cancer Center Maria Sklodowska-Curie National Research Institute of Oncology Warsaw, Warsaw, Poland Department of Uro‑Oncology National Cancer Centre Singapore, Singapore, Singapore Division of Medical Oncology University Hospital Bonn (UKB), 53127 Bonn, Germany Department of Urology Medical University of Graz, Augenbruggerplatz 15, 8010 Graz, Austria Division of Oncology, Department of Internal Medicine Istituto Oncologico Veneto IOV IRCCS, Padua, Italy Oncology 3 Unit, Department of Oncology University Hospital Hradec Kralove, Hradec Kralove, Czechia Department of Clinical Oncology and Radiotherapy Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico Hematology and Oncology Department San Camillo Forlanini Hospital, Rome, Italy Department of Medical Oncology Charles University and Motol University Hospital Prague, Prague, Czech Republic Department of Oncology, Second Faculty of Medicine La Paz University Hospital, Madrid, Spain Medical Oncology Department CHU Insular-Materno Infantil, Las Palmas de Gran Canaria, Spain Medical Oncology Department “Carol Davila” University of Medicine and Pharmacy, Prof. Dr, Bucharest, Romania Department of Obstetrics‑Radiotherapy, Alexandru Trestioreanu Institute of Oncology Newcastle University, Newcastle Upon Tyne, UK Translational and Clinical Research Institute, Centre for Cancer Tawam Hospital, Al Ain, United Arab Emirates Medical Oncology Santa Chiara Hospital, Trento, Italy Medical Oncology Unit National Institute of Oncology, Budapest, Hungary Department of Genitourinary Medical Oncology and Clinical Pharmacology University Hospital of Modena, Modena, Italy Department of Oncology and Hematology Army Hospital Research and Referral, New Delhi, India Department of Medical Oncology Champalimaud Clinical Center, 1400‑038 Lisbon, Portugal Urologic Oncology Sociedad de Oncología y Hematología del Cesar, Valledupar, Colombia Clinical Oncology University Hospital of Parma, 43126 Parma, Italy Medical Oncology Unit ATTIKON University Hospital, National and Kapodistrian University of Athens, Athens, Greece 2nd Propaedeutic Department of Internal Medicine, School of Medicine University of Bari “Aldo Moro” and Division of Medical Oncology, A.O.U. Consorziale Policlinico Di Bari, Bari, Italy Interdisciplinary Department of Medicina Tampere, Finland Finnish Medicines Agency Fimea IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Via Albertoni, 15, Bologna, Italy Medical Oncology
Citations
Santoni, M., Roviello, G., Grande, E., De Giorgi, U., Fiala, O., Seront, E., Molina-Cerrillo, J., Pichler, R., Myint, Z., Kucharz, J., Kanesvaran, R., Büttner, T., Pichler, M., Basso, U., Kopecky, J., Bourlon, M., Cerbone, L., Buchler, T., Pinto, A., & De Liaño, A. (2025). Pembrolizumab-axitinib versus nivolumab-cabozantinib as first-line therapy in patients with metastatic renal cell carcinoma: a retrospective real-world comparison (ARON-1). Cancer Immunology, Immunotherapy, 74(7), 225. https://doi.org/10.1007/s00262-025-04043-x (Original work published 2025)