Paper: What the press release leaves out: the phase 3 melanoma recurrence trial, read against the original papers

On 19 August 2026, Merck and Moderna announced that the phase 3 INTerpath-001 trial had met its primary endpoint of recurrence-free survival and its key secondary endpoint of distant metastasis-free survival, in 1,137 patients with completely resected stage IIB-IV melanoma, randomised 2:1 to intismeran autogene (mRNA-4157 / V940) plus pembrolizumab or pembrolizumab alone. The study underpinning that hypothesis is the phase 2b KEYNOTE-942 trial, published in The Lancet on 17 February 2024: an open-label, non-blinded study of 157 randomised patients —107 to the combination and 50 to monotherapy— in resected stage IIIB-IV melanoma, with a recurrence hazard ratio of 0.561 favouring the combination, grade 3 or higher adverse events in 25% of the combination group against 18% on monotherapy, and declared funding from Moderna in collaboration with Merck Sharp & Dohme. Overall survival —whether these patients live longer— has not been reported in either trial: the phase 3 statement itself notes that the study will continue in order to evaluate it.