Onco Wiki / Regimen

Pembrolizumab adjuvant (resected stage III/IV melanoma; KEYNOTE-054)

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Source YAML: complete record

ComponentsDRUG-PEMBROLIZUMAB
IDREG-PEMBRO-ADJUVANT-MELANOMA
TypeRegimen
Statusreviewed 2026-04-30 | pending_clinical_signoff
DiseasesNone declared
SourcesSRC-ESMO-MELANOMA-2024 SRC-KEYNOTE-054-EGGERMONT-2018 SRC-NCCN-MELANOMA-2025

Notes

KEYNOTE-054 / EORTC-1325 (Eggermont NEJM 2018, Lancet Oncol 2021 5-yr update): adjuvant pembrolizumab 200 mg q3w × 1 yr vs placebo in resected stage III melanoma (n=1019). 12-mo RFS 75.4% vs 61.0% (HR 0.57); 5-yr RFS 55.4% vs 38.3% (HR 0.61); benefit consistent across PD-L1+ and PD-L1- subgroups. Established adjuvant pembrolizumab for resected stage III; basis for FDA approval Feb 2019 + later expansion to stage IIB/IIC (KEYNOTE-716). Start within 12 weeks of surgery; complete 18 cycles unless recurrence / intolerance. Adjuvant nivolumab (CheckMate-238) is interchangeable alternative.

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