Pembrolizumab Plus Axitinib Versus Sunitinib as First-line Treatment of Advanced Renal Cell Carcinoma: 43-month Follow-up of the Phase 3 KEYNOTE-426 Study.

Autor: Plimack ER; Fox Chase Cancer Center, Philadelphia, PA, USA. Electronic address: Elizabeth.Plimack@fccc.edu., Powles T; Barts Health NHS Trust and the Royal Free NHS Foundation Trust, Barts Cancer Institute, London, UK; Queen Mary University of London, London, UK., Stus V; Dnipro State Medical University, Dnipro, Dnipropetrovsk Oblast, Ukraine., Gafanov R; Russian Scientific Center of Roentgenology and Radiology, Moscow, Russia., Nosov D; Central Clinical Hospital With Outpatient Clinic, Moscow, Russia., Waddell T; The Christie NHS Foundation Trust, Manchester, UK., Alekseev B; P. A. Herzen Moscow Oncology Research Institute, Ministry of Health of the Russian Federation, Moscow, Russia., Pouliot F; CHU of Québec and Laval University, Québec, QC, Canada., Melichar B; Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic., Soulières D; Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada., Borchiellini D; Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France., McDermott RS; Adelaide and Meath Hospital, University College Dublin, Belfield, Dublin, Ireland., Vynnychenko I; Sumy Regional Oncology Center, Sumy State University, Sumy, Sumy Oblast, Ukraine., Chang YH; Taipei Veterans General Hospital, Taipei, Taiwan., Tamada S; Bell Land General Hospital, Osaka, Japan., Atkins MB; Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA., Li C; Merck & Co., Inc., Rahway, NJ, USA., Perini R; Merck & Co., Inc., Rahway, NJ, USA., Molife LR; MSD UK, London, UK., Bedke J; University Hospital, Eberhard Karls University Tübingen, Tübingen, Germany., Rini BI; Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
Jazyk: angličtina
Zdroj: European urology [Eur Urol] 2023 Nov; Vol. 84 (5), pp. 449-454. Date of Electronic Publication: 2023 Jul 25.
DOI: 10.1016/j.eururo.2023.06.006
Abstrakt: Previous analyses of KEYNOTE-426, an open-label, phase 3 randomized study, showed superior efficacy of first-line pembrolizumab plus axitinib to sunitinib in advanced clear cell renal cell carcinoma (ccRCC). We report results of the final protocol-prespecified analysis of KEYNOTE-426. Patients received pembrolizumab 200 mg intravenously every 3 wk plus axitinib 5 mg orally twice daily or sunitinib 50 mg orally once daily (4 wk per 6-wk cycle). The dual primary endpoints were overall survival (OS) and progression-free survival (PFS) as per RECIST v1.1 by a blinded independent central review. The secondary endpoints included objective response rate (ORR) and duration of response (DOR). The median study follow-up was 43 (range, 36-51) mo. Benefit with pembrolizumab plus axitinib versus sunitinib was maintained for OS (hazard ratio [HR], 0.73 [95% confidence interval {CI}, 0.60-0.88]), PFS (HR, 0.68 [95% CI, 0.58-0.80]), and ORR (60% vs 40%). The median DOR was 24 (range, 1.4+ to 43+) versus 15 (range, 2.3-43+) mo in the pembrolizumab plus axitinib versus the sunitinib arm. No new safety signals emerged. These results support pembrolizumab plus axitinib as a standard of care for patients with previously untreated advanced ccRCC. PATIENT SUMMARY: Extended results of KEYNOTE-426 support pembrolizumab plus axitinib as the standard of care for advanced clear cell renal cell carcinoma.
(Copyright © 2023. Published by Elsevier B.V.)
Databáze: MEDLINE
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