Newest announced program - intismeran autogene

Announced today, 19 August 2026: Merck and Moderna reported that the Phase 3 INTerpath-001 trial of intismeran autogene plus KEYTRUDA met its co-primary endpoints of recurrence-free survival and distant metastasis-free survival at a pre-specified interim analysis in adjuvant high-risk melanoma - the first individualised mRNA cancer therapy to clear a confirmatory Phase 3.

• Phase 3 INTerpath-001 (V940-001) met co-primary endpoints RFS and DMFS vs. KEYTRUDA alone at interim analysis.
• Individualised therapy: each dose encodes up to 34 neoantigens designed from the patient's own resected tumour.
• Supporting Phase 2b KEYNOTE-942 five-year data: 72.4% vs. 49.1% relapse-free survival, ~49% risk reduction.
• Full data to be presented at an upcoming medical meeting; regulatory filing discussions underway with Merck.
• Context: mFLUSIVA (mRNA-1010) seasonal flu vaccine was FDA-approved 6 Aug 2026 - Moderna's fourth FDA-approved product.