8D Vector Failure Analysis
Trial Vector
Responder
Non-Responder
Alignment Zone
cosine = 0.7241
Vector Math
cos(θ) = (A·B) / (||A|| ||B||)
TARGET RESPONDER0.7241
ITT DILUTED0.4823
Observed HR0.90
Gate Evaluation
GATE 1: TARGET MATCHHIGH — CEACAM5 IS A REAL TARGET
PASS
GATE 2: ENROLLMENT GATEUNSELECTED — IHC 2+ ≥50% INSUFFICIENT
FAIL
GATE 3: OUTCOME CONCORDANCEFAILURE CONFIRMED — PRIMARY ENDPOINTS MISSED
PASS
VERDICTFAILURE_PREDICTED
Layer 1 (Target-Lock)
HIGHReal target
Layer 2 (Mechanism)
LOWUnselected
Combined Prediction
FAILL1:HIGH L2:LOW
Archive Status
LOCKEDFeb 21 2026
Market Significance
Target Sub-Pop230,000+ NSCLC US / Yr
Annual Savings$300M+ Phase III Loss Prevented
A single expression gate threshold change could have identified the responding subpopulation.
System Summary
Database Scored806 TRIALS
Prediction LayerTWO-LAYER AI
StatusFAILURE PREDICTED
Gates2/3 — LAYER 2 FAILED (ENROLLMENT GATE)