학술논문
Adjuvant Pembrolizumab versus IFNα2b or Ipilimumab in Resected High-Risk MelanomaAdjuvant Pembrolizumab in High-Risk Melanoma
Document Type
article
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; Ribas, Antoni
Source
Cancer Discovery. 12(3)
Subject
Language
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.