TY - JOUR
T1 - Adjuvant Pembrolizumab versus IFNα2b or Ipilimumab in Resected High-Risk Melanoma
AU - Grossmann, Kenneth F.
AU - Othus, Megan
AU - Patel, Sapna P.
AU - Tarhini, Ahmad A.
AU - Sondak, Vernon K.
AU - Knopp, Michael V.
AU - Petrella, Teresa M.
AU - Truong, Thach Giao
AU - Khushalani, Nikhil I.
AU - Cohen, Justine V.
AU - Buchbinder, Elizabeth I.
AU - Kendra, Kari
AU - Funchain, Pauline
AU - Lewis, Karl D.
AU - Conry, Robert M.
AU - Chmielowski, Bartosz
AU - Kudchadkar, Ragini R.
AU - Johnson, Douglas B.
AU - Li, Hongli
AU - Moon, James
AU - Eroglu, Zeynep
AU - Gastman, Brian
AU - Kovacsovics-Bankowski, Magdalena
AU - Gunturu, Krishna S.
AU - Ebbinghaus, Scot W.
AU - Ahsan, Sama
AU - Ibrahim, Nageatte
AU - Sharon, Elad
AU - Korde, Larissa A.
AU - Kirkwood, John M.
AU - Ribas, Antoni
N1 - Publisher Copyright:
© 2021 American Association for Cancer Research.
PY - 2022/3/1
Y1 - 2022/3/1
N2 - 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 treatmentrelated 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. SIGNIFICANCE: Adjuvant 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.
AB - 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 treatmentrelated 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. SIGNIFICANCE: Adjuvant 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.
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U2 - 10.1158/2159-8290.CD-21-1141
DO - 10.1158/2159-8290.CD-21-1141
M3 - Article
C2 - 34764195
AN - SCOPUS:85125965385
SN - 2159-8274
VL - 12
SP - 644
EP - 653
JO - Cancer discovery
JF - Cancer discovery
IS - 3
ER -