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

Abstract

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 .

• Authors: 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
• Journal: Nature medicine (Nat Med) Vol. 29 Issue 11 Pg. 2835-2843 (Nov 2023) ISSN: 1546-170X [Electronic] United States
• PMID: 37845511 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © 2023. The Author(s).

Chemical References

• Adjuvants, Immunologic
• Nivolumab

Topics

• Humans
• Adjuvants, Immunologic
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Double-Blind Method
• Melanoma (drug therapy, surgery)
• Neoplasm Staging
• Nivolumab
• Skin Neoplasms (drug therapy, surgery)
• Melanoma, Cutaneous Malignant