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

19Sep

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.