First Phase 3 success for a personalized mRNA therapeutic melanoma vaccine

Merck and Moderna announce that their individualized neoantigenic vaccine, combined with Keytruda, significantly delays the recurrence of operated melanoma. This is a first for this approach.

Merck and Moderna announced on August 19, 2026 that their pivotal INTerpath-001 trial met its primary endpoint and a key secondary endpoint. The study included 1,137 patients with fully resected stage IIB to IV cutaneous melanoma, divided between a combination vaccine plus pembrolizumab (Keytruda) and pembrolizumab alone.

The combination statistically significantly improves recurrence-free survival as well as distant metastasis-free survival. No new safety signals were reported. This is the first positive phase 3 result obtained by individualized neoantigen therapy, and more broadly by mRNA cancer treatment.

A vaccine made from the patient's tumor

The product, autogenous intismeran, is designed from a sample of the patient's tumor: genetic sequencing identifies its own mutational signature, then an algorithmic treatment selects up to 34 specific neoantigens, encoded in a synthetic messenger RNA intended to direct the immune system against these targets. The two laboratories plan to present the complete data at an international congress and to initiate regulatory discussions with a view to submitting an application.