Melanoma: phase 3 results for personalised mRNA therapy after surgery
Merck–Moderna report a lower relative risk of recurrence or death with the combination. Overall survival data remain immature.
Merck and Moderna announced detailed results from the phase 3 INTerpath-001 trial on 22 October 2026. They concern the individualised mRNA therapy intismeran autogene with pembrolizumab in patients with completely surgically resected stage IIB–IV cutaneous melanoma.
What was measured
The randomised, double-blind trial enrolled 1,137 patients. The combination was compared with pembrolizumab plus placebo. After a median follow-up of 24.6 months, the companies report a 42% reduction in the relative risk of recurrence or death in the primary analysis: a hazard ratio of 0.58, with a 95% confidence interval of 0.45–0.75.
At two years, estimated recurrence-free survival was 82.2% with the combination versus 70.0% in the comparator group — a difference of 12.2 percentage points. The 42% refers to a relative change in the composite endpoint; it does not mean a 42% reduction in mortality.
What remains under evaluation
Overall survival data are not yet mature and the trial continues. Grade 3–5 treatment-related adverse events were reported in 14.2% versus 13.4% respectively. The companies say no new safety signals were observed; this does not mean there were no adverse events.
Intismeran is designed around the individual characteristics of each patient’s tumour. It is a therapeutic approach after surgery, not a preventive vaccine for the general population.
The announcement describes the therapy as investigational, reports engagement with regulatory authorities and a planned presentation at ESMO 2026. The findings come from the developers’ announcement; they are not an announcement of approval or availability in Greece.
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