Hazard Ratio (HR)
0.56
95% CI (0.31 - 1.02)
Projected 3-Yr Vaccine RFS
74.8%
~27 / 107 Recurrences
Projected 3-Yr Control RFS
55.6%
~22 / 50 Recurrences
Absolute Risk Reduction
+19.2%
44% Relative Risk Reduction
Nominal P-Value
p = 0.013
One-sided log-rank
Kaplan-Meier Recurrence-Free Survival Curve (KEYNOTE-942 Benchmark)
mRNA-4157 + Pembrolizumab
Pembrolizumab Monotherapy
Number of Patients at Risk
| Cohort / Time (Months) |
|---|
| mRNA-4157 + Pembro |
| Pembro Monotherapy |
Subgroup Hazard Ratio Forest Plot Favors Combination < 1.0 > Favors Monotherapy
Clinical Evidence & Readout Timeline
Phase 2b
KEYNOTE-942 3-Year & 5-Year Durable RFS Readouts
Confirmed ~44% RFS reduction (HR 0.56) and ~65% DMFS reduction (HR 0.35) at 36 months, proving sustained neoantigen T-cell memory.
Regulatory
FDA Breakthrough Therapy & EMA PRIME Designation
Granted based on personalized 34-neoantigen design generating targeted polyclonal CD8+/CD4+ neoepitope responses.
Phase 3
V940-001 (INTerpath-001) Confirmatory Global Trial (N=1,089)
Evaluating adjuvant mRNA-4157 + Pembro in high-risk stage IIB-IV melanoma across global clinical centers.