Transgene: Corporate Overview (Transgene) - Dec 6, 2014 - “TG4010: PHASE 2B TIME TRIAL RESULTS”; “Primary objective: PFS to prospectively validate the TrPAL predictive biomarker: As recommended by the FDA, primary endpoint based on a Bayesian design: pooling PFS data from TIME Phase 2b trial and earlier study in NSCLC to accelerate time to results and with fewer patients”; “In Normal TrPAL group, probability that TG4010 induces reduction in disease progression or death - i.e., hazard ratio (HR) <1 is 98.6%: Thus, Phase 2b part of TIME study after 144 events of progression passes Bayesian probability threshold of 95%”; “In High TrPAL group, number of events needed to perform primary analysis not yet reached”; “All other analyses in study based on traditional Frequentist approach”
P2 data • Non Small Cell Lung Cancer
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