Final analysis of nivolumab plus cabozantinib for advanced renal cell carcinoma from the randomized phase III CheckMate 9ER trial

作者：Robert J. Motzer, Bernard Escudier, Mauricio Burotto, Thomas Powles, Andrea B. Apolo, María T. Bourlon, Amishi Y. Shah, Camillo Porta, Cristina Suárez, Carlos H. Barrios, Martin Eduardo Richardet, Howard Gurney, Elizabeth R. Kessler, Yoshihiko Tomita, Jens Bedke, Christian Scheffold, Margarita Askelson, Julie Panzica, J. Zhang, Maximiliano van Kooten Losio, Toni K. Choueiri · 发表于：Annals of Oncology · 年份：2025 · DOI：10.1016/j.annonc.2025.09.006 · 被引用次数：23 · 研究领域：Renal cell carcinoma treatment、Cancer Immunotherapy and Biomarkers、Ferroptosis and cancer prognosis

BACKGROUND: Nivolumab plus cabozantinib (NIVO+CABO) showed significant benefits over sunitinib (SUN) in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) for previously untreated advanced renal cell carcinoma (RCC) in the phase III CheckMate 9ER trial (NCT03141177). We report final, updated efficacy and safety results with median follow-up of 5.6 years. PATIENTS AND METHODS: Patients with advanced RCC were randomized to first-line NIVO 240 mg intravenously every 2 weeks plus CABO 40 mg p.o. o.d. or SUN 50 mg p.o. o.d. (4 weeks each 6-week cycle) until disease progression or unacceptable toxicity (maximum 2 years of NIVO). The primary endpoint was PFS per RECIST v1.1 by blinded independent central review (BICR). Secondary endpoints included OS, ORR per RECIST v1.1 by BICR, and safety. RESULTS: Median (range) follow-up was 5.6 years [67.6 (60.2-80.2) months]. In intent-to-treat patients (NIVO+CABO, n = 323; SUN, n = 328), PFS favored NIVO+CABO versus SUN [hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.49-0.70]. Median PFS was 16.4 versus 8.3 months, respectively; 60-month PFS rates were 13.6% versus 3.6%. OS favored NIVO+CABO versus SUN (HR 0.79, 95% CI 0.65-0.96). Median OS was 46.5 versus 35.5 months, respectively; 60-month OS rates were 40.9% versus 35.4%. ORR was greater with NIVO+CABO versus SUN (55.7% versus 27.4%; complete response 13.9% versus 4.6%). The probability of remaining in response through 60 months with NIVO+CABO...