MVA-MUC1-IL2: Updated Phase IIb data

Updated data from 217 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 met the primary endpoint of improving PFS vs. placebo in patients with normal baseline levels of triple-positive activated lymphocytes (CD16+, CD56+ and CD69+ lymphocytes) (n=170). In January, Transgene said TG4010 plus chemotherapy missed the primary endpoint in the subgroup (see BioCentury, Jan. 13). Transgene said the original analysis was conducted per protocol after >=89 progression events occurred in the subgroup and that the updated analysis was conducted after 137 progression events occurred.

The subgroup of patients with high baseline levels of triple-positive activated lymphocytes (n=47) has not yet met the required number of events required for the primary endpoint analysis. Transgene said the primary endpoint of the Phase IIb portion was to assess the predictive value of the triple-positive activated lymphocyte biomarker. In patients with non-squamous NSCLC (n=191), TG4010 significantly improved PFS vs. placebo (p=0.02). OS data are not yet mature, but are expected to be presented this year. ...