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Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: Final results regarding distant metastasis-free survival from the EORTC 1325-MG/Keynote 054 double-blinded phase III trial
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- keynote 054 NCT02362594 esmo 2020
KEYNOTE-054 Results at ESMO 2020
Abstract No : Abstract #LBA46
Indication : Melanoma
Intervention : Pembrolizumab
Company : Merck & Co.
Technology : Immune Checkpoint Inhibitor (ICI)
Results:
By April 2020, 418 DMFS events were reported. At 3.5 yr median follow-up, pembrolizumab compared with placebo significantly prolonged DMFS in the overall population (3.5-yr DMFS rate: 65.3% vs 49.4%; HR 0.60, 95% CI 0.49-0.73; P<0.0001) and in the PD-L1-positive tumor (N=853; HR 0.61; 95% CI 0.49-0.76; P<0.0001). The impact of pembrolizumab on DMFS was similar in pts with a PD-L1-negative tumor (N=116; HR 0.49, 99% CI 0.24-0.99) and in other subgroups, in particular according to AJCC-7 and -8 staging, and BRAF mutation status. The RFS improvement was confirmed (HR in the ITT population 0.59; 95% CI 0.49-0.70).
Conclusion:
At 3.5-yr median follow-up, pembrolizumab adjuvant therapy provided a clinically meaningful improvement in DMFS in resected high-risk stage III melanoma pts.
Executive Summary
Long term findings demonstrate sustained RFS benefit, by reducing the risk of death by 40% vs placebo (HR 0.60). 3.5-year DMFS rates 65.3% vs 49.4%.Adjuvant pembrolizumab decreased the incidence of distant metastasis as a first recurrence by 43% (at 3.5 years: 24.9% vs 39.5%, HR= 0.57. No new safety data were identified as part of the 42-month analysis.