MVA-MUC1-IL2: Phase IIb data

Top-line data from 210 patients with MUC1-positive stage IV NSCLC in the Phase IIb portion of the double-blind, international Phase IIb/III TIME trial showed that first-line treatment with subcutaneous TG4010 plus chemotherapy missed the primary endpoint of improving PFS vs. placebo in patients with normal baseline levels of triple-positive activated lymphocytes (CD16+, CD56+ and CD69+ lymphocytes) based on a pre-specified threshold of the upper limit of normal (n=170). Transgene said the primary endpoint of the Phase IIb portion was to assess the predictive value of the triple-positive activated lymphocyte biomarker. ...