Journal Article

DKFZ-2025-00757

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Long-term follow-up, crossover, and rechallenge with pembrolizumab in the phase III KEYNOTE-716 study.

Luke, J. J. ; Ascierto, P. A. ; Khattak, M. A. ; Rutkowski, P. ; Del Vecchio, M. ; Spagnolo, F. ; Mackiewicz, J. ; Merino, L. d. l. C. ; Chiarion-Sileni, V. ; Kirkwood, J. M. ; Robert, C. ; Schadendorf, D.DKFZ* ; de Galitiis, F. ; Carlino, M. S. ; Dummer, R. ; Mohr, P. ; Odeleye-Ajakaye, A. ; Fukunaga-Kalabis, M. ; Krepler, C. ; Eggermont, A. M. M. ; Long, G. V.

2025
Elsevier Amsterdam [u.a.]

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Please use a persistent id in citations: doi:10.1016/j.ejca.2025.115381

Abstract: Adjuvant pembrolizumab prolonged recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with resected stage IIB/IIC melanoma in KEYNOTE-716. Results of a post hoc 4-year analysis are reported, including progression/recurrence-free survival 2 (PRFS2).Patients were randomly assigned 1:1 to pembrolizumab 200 mg or placebo intravenously every 3 weeks (part 1). RFS was the primary end point; DMFS was secondary. Patients with recurrence following placebo or 17 cycles of pembrolizumab could cross over to or be rechallenged with pembrolizumab (part 2).Median follow-up (n = 976) was 52.8 months (range, 39.4-64.8). RFS (HR, 0.62 [95 % CI, 0.50-0.78]) and DMFS (HR, 0.59 [0.45-0.77]) favored pembrolizumab. At 48 months, RFS rates were 71.3 % for pembrolizumab and 58.3 % for placebo, and DMFS rates were 81.0 % and 70.1 %, respectively. The HR for PRFS2 was 0.75 (95 % CI, 0.56-1.01); 48-month PRFS2 rates were 82.5 % for pembrolizumab and 76.7 % for placebo. In the crossover population, median follow-up was 36.9 months; median RFS was not reached (NR; 95 % CI, 16.8-NR; 48-month RFS, 50.6 %) in patients with resectable disease (n = 41) and median progression-free survival was 22.0 months (4.5-NR) in patients with unresectable disease (n = 30). Among patients rechallenged, median follow-up was 21.9 months; none with resectable disease had recurrence (n = 6) and 1 with unresectable disease had best response of stable disease (n = 3). No new safety signals were observed.With > 4 years follow-up, pembrolizumab continued to prolong RFS and DMFS and had antitumor activity in patients who crossed over to pembrolizumab.NCT03553836.

Keyword(s): Adjuvant therapy ; Immune checkpoint inhibitors ; Melanoma ; Pembrolizumab ; Programmed cell death protein 1

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Contributing Institute(s):

1. DKTK Koordinierungsstelle Essen/Düsseldorf (ED01)

Research Program(s):

1. 899 - ohne Topic (POF4-899) (POF4-899)

Appears in the scientific report 2025

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; ; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Current Contents - Life Sciences ; Ebsco Academic Search ; Essential Science Indicators ; IF >= 5 ; JCR ; Nationallizenz ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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