Readout
Run KEYNOTE-942 readout
Downstream gates
FDA review
Manufacturing
Payer adoption
OS maturity
Scenario
All gates pass
A gate fails or delays
KEYNOTE-942 proof-to-revenue gate path
mRNA-4157 · V940
neoantigen payload
patient-specific
APC priming
antigen display
T-cell
anti-PD-1 · Keytruda
PD-1
PROOF GATE
KEYNOTE-942
phase 3 · melanoma
BLA filing
H1 2027
FDA review
approval
Manufacturing
at scale
Payer adoption
reimbursement
OS maturity
overall survival
US commercialization
onco platform
premium
awaiting readout
Readout pending.
Regulatory path stays locked until the KEYNOTE-942 proof gate passes.