Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial

被引:0
作者
John M. Kirkwood
Michele Del Vecchio
Jeffrey Weber
Christoph Hoeller
Jean-Jacques Grob
Peter Mohr
Carmen Loquai
Caroline Dutriaux
Vanna Chiarion-Sileni
Jacek Mackiewicz
Piotr Rutkowski
Petr Arenberger
Gaelle Quereux
Tarek M. Meniawy
Paolo A. Ascierto
Alexander M. Menzies
Piyush Durani
Maurice Lobo
Federico Campigotto
Brian Gastman
Georgina V. Long
机构
[1] UPMC Hillman Cancer Center,
[2] Fondazione IRCCS Istituto Nazionale dei Tumori,undefined
[3] NYU Langone Medical Center,undefined
[4] Medizinische Universität Wien,undefined
[5] Hôpital de la Timone,undefined
[6] Elbe Klinikum Buxtehude,undefined
[7] University Medical Center Mainz,undefined
[8] Hôpital Saint André,undefined
[9] Istituto Oncologico Veneto,undefined
[10] IOV-IRCCS,undefined
[11] Institute of Oncology,undefined
[12] Poznan University of Medical Sciences,undefined
[13] Maria Skłodowska-Curie National Research Institute of Oncology,undefined
[14] Charles University Third Faculty of Medicine and University Hospital Královské Vinohrady,undefined
[15] Nantes University Hospital,undefined
[16] University of Western Australia and Sir Charles Gairdner Hospital,undefined
[17] Istituto Nazionale Tumori IRCCS ‘Fondazione G. Pascale’,undefined
[18] Melanoma Institute Australia,undefined
[19] University of Sydney,undefined
[20] and Royal North Shore and Mater Hospitals,undefined
[21] Bristol Myers Squibb,undefined
[22] Cleveland Clinic,undefined
来源
Nature Medicine | 2023年 / 29卷
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摘要
Patients with resected stage IIB/C melanoma have high recurrence risk, similar to those with resected stage IIIA/B disease. The phase 3, double-blind CheckMate 76K trial assessed 790 patients with resected stage IIB/C melanoma randomized 2:1 (stratified by tumor category) to nivolumab 480 mg or placebo every 4 weeks for 12 months. The primary endpoint was investigator-assessed recurrence-free survival (RFS). Secondary endpoints included distant metastasis-free survival (DMFS) and safety. At 7.8 months of minimum follow-up, nivolumab significantly improved RFS versus placebo (hazard ratio (HR) = 0.42; 95% confidence interval (CI): 0.30–0.59; P < 0.0001), with 12-month RFS of 89.0% versus 79.4% and benefit observed across subgroups; DMFS was also improved (HR = 0.47; 95% CI: 0.30–0.72). Treatment-related grade 3/4 adverse events occurred in 10.3% (nivolumab) and 2.3% (placebo) of patients. One treatment-related death (0.2%) occurred with nivolumab. Nivolumab is an effective and generally well-tolerated adjuvant treatment in patients with resected stage IIB/C melanoma. ClinicalTrials.gov identifier: NCT04099251.
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页码:2835 / 2843
页数:8
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