Achievement of Phase 3 RFS Primary Endpoint and Acceleration of Standard of Care Transition

Moderna (MRNA) and Merck & Co. (MRK) have demonstrated that the co-developed personalized neoantigen cancer vaccine, intismeran autogene (V940/mRNA-4157), significantly improved the primary endpoint of Recurrence-Free Survival (RFS) in the global Phase 3 INTerpath-001 (NCT05lar05933577) trial involving 1,137 patients with high-risk resected melanoma. The trial proved superior therapeutic efficacy in combination therapy, drastically reducing the risk of cancer recurrence and distant metastasis compared to the current Standard of Care (SoC), Keytruda (pembrolizumab) monotherapy. This decisive achievement demonstrates that the 49% reduction in recurrence risk observed during the previous 2b phase KEYNOTE-942 five-year follow-up has been replicated in a large-scale randomized Phase 3 trial.

Personalized Immune Induction Technology Based on 34 Neoantigen Selection Algorithm

Intismeran is a personalized therapy manufactured by analyzing a patient's tumor tissue via Next-Generation Sequencing (NGS) and selecting up to 34 unique neoantigens using an AI-based bioinformatics algorithm. It is designed to induce a broader immune response and concentrate the activation of cytotoxic T-cells (CD8+ T-cells) compared to competitor BioNTech's (BNTX) iNeST platform (up to 20 neoantigens). By precisely targeting minimal residual disease (MRD) latent in the body after surgery, it effectively overcomes the treatment resistance that occurs with single-agent immune checkpoint inhibitor administration.

Commencement of Formal FDA/EMA Marketing Authorization Applications Following Regulatory Barrier Removal

While both companies secured FDA Breakthrough Therapy and EMA PRIME designations in 2023, they faced review delays during the 2024 pursuit of Phase 2-based Accelerated Approval due to failure to meet Phase 3 patient enrollment requirements. However, with the achievement of the Phase 3 primary endpoint, they have completely cleared regulatory risks and have immediately entered the formal Biologics License Application (BLA) and Marketing Authorization Application (MAA) processes with the FDA and EMA. This marks a historic milestone where mRNA technology, previously limited to infectious disease prevention, achieves its first formal approval in the field of treating severe malignant tumors.

50:50 Partnership Value and Expansion of Global Follow-up Pipelines

In October 2022, Merck exercised an option worth USD 250M to secure 50:50 global development and commercialization rights. For Merck, facing the 2028 Keytruda patent cliff, this result serves as a critical defensive line to protect blockbuster revenues of $25 billion annually. For Moderna, this provides momentum to reduce dependence on COVID-19 vaccine revenue and strengthens the foundation for long-term growth through the development of nine follow-up Phase 2/3 pipelines, including non-small cell lung cancer (INTerpath-002) and renal cell carcinoma.