1. Adjuvant Pembrolizumab versus IFNα2b or Ipilimumab in Resected High-Risk MelanomaAdjuvant Pembrolizumab in High-Risk Melanoma
- Author
-
Grossmann, Kenneth F, Othus, Megan, Patel, Sapna P, Tarhini, Ahmad A, Sondak, Vernon K, Knopp, Michael V, Petrella, Teresa M, Truong, Thach-Giao, Khushalani, Nikhil I, Cohen, Justine V, Buchbinder, Elizabeth I, Kendra, Kari, Funchain, Pauline, Lewis, Karl D, Conry, Robert M, Chmielowski, Bartosz, Kudchadkar, Ragini R, Johnson, Douglas B, Li, Hongli, Moon, James, Eroglu, Zeynep, Gastman, Brian, Kovacsovics-Bankowski, Magdalena, Gunturu, Krishna S, Ebbinghaus, Scot W, Ahsan, Sama, Ibrahim, Nageatte, Sharon, Elad, Korde, Larissa A, Kirkwood, John M, and Ribas, Antoni
- Subjects
Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Immunology ,Cancer ,Comparative Effectiveness Research ,Clinical Trials and Supportive Activities ,Clinical Research ,Patient Safety ,6.1 Pharmaceuticals ,Adjuvants ,Immunologic ,Antibodies ,Monoclonal ,Humanized ,Antineoplastic Agents ,Immunological ,Humans ,Ipilimumab ,Melanoma ,Risk Assessment ,Biochemistry and cell biology ,Oncology and carcinogenesis - Abstract
We conducted a randomized phase III trial to evaluate whether adjuvant pembrolizumab for one year (647 patients) improved recurrence-free survival (RFS) or overall survival (OS) in comparison with high-dose IFNα-2b for one year or ipilimumab for up to three years (654 patients), the approved standard-of-care adjuvant immunotherapies at the time of enrollment for patients with high-risk resected melanoma. At a median follow-up of 47.5 months, pembrolizumab was associated with significantly longer RFS than prior standard-of-care adjuvant immunotherapies [HR, 0.77; 99.62% confidence interval (CI), 0.59-0.99; P = 0.002]. There was no statistically significant association with OS among all patients (HR, 0.82; 96.3% CI, 0.61-1.09; P = 0.15). Proportions of treatment-related adverse events of grades 3 to 5 were 19.5% with pembrolizumab, 71.2% with IFNα-2b, and 49.2% with ipilimumab. Therefore, adjuvant pembrolizumab significantly improved RFS but not OS compared with the prior standard-of-care immunotherapies for patients with high-risk resected melanoma.SignificanceAdjuvant PD-1 blockade therapy decreases the rates of recurrence, but not survival, in patients with surgically resectable melanoma, substituting the prior standard-of-care immunotherapies for this cancer. See related commentary by Smithy and Shoushtari, p. 599. This article is highlighted in the In This Issue feature, p. 587.
- Published
- 2022