MRNA · News · 20260819N

Product / Drug Pipeline Progress

Moderna, Inc. · 2026-08-19 · Importance 30 · Surprise 42 · In source text

Moderna and Merck reported positive Phase 3 results for intismeran autogene, also known as intismeran, V940, or mRNA-4157, combined with Merck’s KEYTRUDA in high-risk melanoma patients. The individualized mRNA neoantigen therapy met its primary recurrence-free-survival endpoint and secondary distant-metastasis-free-survival endpoint versus KEYTRUDA alone. The result is described as the first positive late-stage trial for an individualized neoantigen therapy and an mRNA-based cancer therapy, strengthening Moderna’s strategy to expand beyond infectious-disease vaccines. The companies plan to present full data and engage with regulators, while analysts await overall-survival results and evidence that personalized manufacturing can scale commercially.

Key facts

• Moderna aims to bring the experimental mRNA-based melanoma drug to market by 2027. source
• Merck and Moderna announced positive topline results from the Phase 3 INTerpath-001 trial evaluating adjuvant treatment with intismeran autogene (intismeran; V940 or mRNA-4157) in combination with KEYTRUDA®. source
• The INTerpath-001 Phase 3 trial met endpoints of Recurrence-Free Survival (RFS) and Distant Metastasis-Free Survival (DMFS) in patients with completely resected Stage IIB-IV melanoma. source
• The INTerpath-001 result is described as the first positive Phase 3 readout for an individualized neoantigen therapy and an mRNA-based cancer therapy. source
• Moderna's individualized neoantigen therapy combined with Merck's Keytruda reduced skin cancer recurrence and spread compared with Keytruda alone, according to Merck and Moderna's announcement. source

Impact estimates