Results Of The Phase Iib Part Of Time Study Evaluating Tg4010 Immunotherapy In Stage Iv Non-Small Cell Lung Cancer (Nsclc) Patients Receiving First Line Chemotherapy.

3034 Background: TG4010 is an immunotherapy using an attenuated and modified poxvirus (MVA) coding for MUC1 and interleukin-2. A previous study showed that the baseline level of Triple Positive Activated Lymphocytes (TrPAL, CD16+CD56+CD69+) might be a predictive biomarker for TG4010 efficacy in NSCLC. Methods: TIME is a double blind, placebo-controlled phase IIb/III study. The phase IIb part compared first line chemotherapy combined with TG4010 or placebo and further assessed the predictive value of baseline level of TrPAL. Eligibility criteria included stage IV NSCLC not previously treated, MUC1+ tumor by immunohistochemistry (IHC), PS ≤ 1. TG4010 108pfu or placebo was given SC weekly for 6 weeks (w), then every 3w up to progression in immediate combination with chemotherapy. Primary endpoint was progression-free survival (PFS). Results: 222 patients (pts) were randomized 1:1. In pts with normal TrPAL the study met the primary endpoint of having a Bayesian probability for HR 95%. PFS was sign...