- Moderna Inc MRNA and Merck & Co Inc MRK announced distant metastasis-free survival (DMFS) results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study of mRNA-4157 (V940) plus Keytruda for resected high-risk melanoma.
- The candidate is an investigational individualized neoantigen therapy.
- The companies recently announced the first presentation of the study's primary endpoint, recurrence-free survival, from the Phase 2 KEYNOTE-942/mRNA-4157-P201 trial in April 2023 at the American Association for Cancer Research Annual Meeting.
- mRNA-4157 (V940) plus Keytruda demonstrated a statistically significant and clinically meaningful improvement in DMFS, compared with Keytruda.
- The combo therapy reduced the risk of developing distant metastasis or death by 65%.
- Data from an exploratory subgroup analysis evaluating minimal residual disease (MRD) by circulating tumor DNA (ctDNA) as a biomarker of RFS were also presented.
- Most ctDNA-evaluable patients were ctDNA-negative at baseline (88.0%, n=110/125), compared to ctDNA-positive patients at baseline (12.0%, n=15/125).
- In ctDNA-negative patients at baseline, RFS was higher with mRNA-4157 (V940) in combination with Keytruda versus Keytruda alone, representing a 78% reduction in recurrence or death.
- A similar trend was observed for ctDNA-positive patients.
- However, the small sample size of the ctDNA subgroups limits the interpretation of these results.
- The association between MRD patterns and mRNA-4157 (V940) treatment effect will be further explored in upcoming planned studies.
- Price Action: MRNA shares are down 1.04% at $129.15, and MRK shares are up 0.49% at $113.07 on the last check Monday.
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