# KEYNOTE-054 (EORTC 1325): adjuvant pembrolizumab versus placebo in resected stage III melanoma

Source: https://onco.cc/key-papers/paper-keynote-054-eggermont-nejm-2018/  
OnCo record `paper-keynote-054-eggermont-nejm-2018` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A year of pembrolizumab after surgery for stage III melanoma cut the risk of recurrence by 43 percent compared with placebo, the first placebo-controlled proof that adjuvant PD-1 blockade works.

## Summary

Phase 3 placebo-controlled trial of 1,019 patients with completely resected stage III melanoma randomised to pembrolizumab or placebo for one year.

Twelve-month recurrence-free survival was 75.4 versus 61.0 percent (hazard ratio 0.57), consistent across PD-L1 and BRAF subgroups; five-year recurrence-free survival was 55.4 versus 38.3 percent and distant metastasis-free survival was also improved, with grade 3 or higher immune-related events in 7.1 percent.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2018
- DOI: 10.1056/NEJMoa1802357
- Authors: Eggermont AMM, Blank CU, Mandala M, et al.
- Findings: Twelve-month recurrence-free survival 75.4 percent vs 61.0 percent; hazard ratio 0.57.; Five-year recurrence-free survival 55.4 percent vs 38.3 percent.
- What it means: Adjuvant pembrolizumab is a standard for resected stage III melanoma, with subsequent trials extending it to stage II and to the neoadjuvant setting.
- Caveats: Overall survival benefit not demonstrated, as placebo patients could receive pembrolizumab at relapse.

## Sources

- N Engl J Med 2018: https://doi.org/10.1056/NEJMoa1802357
- PubMed: https://pubmed.ncbi.nlm.nih.gov/29658430/

## Connected records

- cancers: [Stage III melanoma (after surgery)](https://onco.cc/cancers/stage-iii-melanoma/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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