RAHWAY, N.J. & CAMBRIDGE, Mass. — August 19, 2026 — Merck and Moderna today announced that the Phase 3 INTerpath-001 trial evaluating intismeran autogene (V940/mRNA-4157) in combination with KEYTRUDA met its primary endpoint of recurrence-free survival (RFS) and its key secondary endpoint of distant metastasis-free survival (DMFS) in patients with completely resected Stage IIB-IV melanoma.

This marks the first positive Phase 3 readout for both an individualized neoantigen therapy and an mRNA-based cancer therapy, and the first Phase 3 study to demonstrate a clinically meaningful improvement over KEYTRUDA alone in the adjuvant melanoma setting.

At the pre-specified interim analysis, intismeran autogene plus KEYTRUDA demonstrated statistically significant and clinically meaningful improvements in RFS and DMFS compared with KEYTRUDA monotherapy in patients with completely resected Stage IIB, IIC, III or IV cutaneous melanoma who had not received prior systemic therapy.

Safety profiles were consistent with previous reports, with no new safety signals identified. The study continues to evaluate additional endpoints, including overall survival.

“This is the first Phase 3 study to show that intismeran can reduce the risk of recurrence or death compared to KEYTRUDA alone.” — Professor Georgina Long, principal investigator, Melanoma Institute Australia

“These first Phase 3 findings reinforce the promise of a more personalized approach to cancer treatment.” — Dr. Dean Y. Li, president, Merck Research Laboratories

INTerpath-001 (NCT05933577) is a randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 trial. It enrolled 1,137 patients with high-risk resected cutaneous melanoma, randomized 2:1 to intismeran autogene plus KEYTRUDA, or KEYTRUDA alone.