Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial

RCT (n=1019) found pembrolizumab adjuvant therapy linked to improvement in distant metastasis-free survival at 3.5-year median follow-up vs. placebo (ITT population: 65·3 vs. 49·4%; HR 0·60; 95% CI 0·49–0·73; p<0·0001 & 66.7 vs. 51.6% in 853 patients with PD-L1-positive tumours).

SPS commentary:

This is one of two reports in The Lancet Oncology, providing updated results of secondary and exploratory outcomes of the European Organisation for Research and Treatment of Cancer (EORTC) 1325-MG/KEYNOTE-054 trial.

In the other analysis, pembrolizumab did not result in clinically significant decrease in HRQOL vs. placebo when given as adjuvant therapy in this population (difference in average GHQ score between two groups over the 2 years was −2.2 points).

A commentary notes current evidence has confirmed the role of adjuvant therapy for melanoma, but challenges remain, and further data are needed to guide patient selection and treatment decisions. In addition, the introduction of neoadjuvant therapy with the potential to reduce the extent of surgery and allow personalised follow-up and adjuvant therapy are likely to be further promising innovations in the future of melanoma treatment

The Lancet Oncology

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Quality-of-life results data

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