European Medicines Agency grants intismeran PRIME designation

Moderna/Intismeran autogene (mRNA-4157/V940)

The European Medicines Agency admitted intismeran (mRNA-4157/V940) plus Keytruda to PRIME, its programme of early support and faster evaluation for unmet-need medicines, for high-risk stage III/IV melanoma after surgery. The basis was the 157-patient Phase 2b KEYNOTE-942 trial.

• PRIME accelerates development and review timelines; Moderna/Merck now in Phase 3 (INTerpath-001).
• Intismeran is a personalised neoantigen vaccine tailored to individual tumor mutations.
• KEYNOTE-942 Phase 2b showed 18-month RFS 79% (intismeran + Keytruda) vs 62% (Keytruda alone).
• PRIME designation provides regulatory pathway certainty for personalized mRNA cancer therapy.