Moderna, Inc. (NASDAQ: MRNA) and Merck (NYSE: MRK), also known as MSD outside the United States and Canada, today revealed follow-up data from their collaborative Phase 2b KEYNOTE-942/mRNA-4157-P201 study. This clinical trial evaluates mRNA-4157 (V940), an innovative individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, for patients with resected high-risk melanoma (stage III/IV) after complete resection.

Continued Improvement in Clinical Outcomes

The median follow-up of approximately three years showed that adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA significantly improved recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) compared to KEYTRUDA alone. This combination therapy reduced the risk of recurrence or death by 49% and the risk of developing distant metastasis or death by 62%.

A Milestone in Melanoma Therapy

Kyle Holen, M.D., Senior Vice President and Head of Development, Therapeutics and Oncology at Moderna, highlighted the robust clinical benefits of mRNA-4157 (V940) as an adjuvant treatment. This study marks the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first to show a significant benefit over KEYTRUDA alone in adjuvant melanoma.

Merck’s Commitment to Advancing Cancer Research

Dr. Marjorie Green, senior vice president and head of late-stage oncology at Merck Research Laboratories, emphasized Merck’s dedication to exploring innovative modalities in early stages of cancer. The company aims to combine its expertise in immuno-oncology with Moderna’s mRNA technology to make impactful advancements for patients.

Safety Profile and Regulatory Designations

The adverse events associated with mRNA-4157 (V940) in the KEYNOTE-942 study remain consistent with previous reports, showing similar rates of treatment-related Grade ≥ 3 adverse events compared to KEYTRUDA alone. mRNA-4157 (V940) in combination with KEYTRUDA has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and Priority Medicines (PRIME) scheme designation from the European Medicines Agency.

Ongoing Research and Future Development

Moderna and Merck are continuing their research with the initiation of a Phase 3 randomized INTerpath-001 clinical trial evaluating mRNA-4157 (V940) in combination with KEYTRUDA. They also plan to expand the development program to additional tumor types, signifying a significant step in the fight against cancer.

  Keytruda, Kyle Holen, Melanoma, Merck, Moderna, mRNA-4157