Transgene SA announced topline preliminary results from the Phase 2b part of the Phase 2b/3 TIME trial evaluating TG4010 MUC-1 targeted immunotherapy in combination with chemotherapy versus placebo plus chemotherapy in the first-line treatment of MUC-1 positive advanced non-small cell lung cancer (NSCLC) patients. The primary objective of the Phase 2b part of the study was to validate the triple-positive activated lymphocytes (TrPAL) predictive biomarker; the safety and efficacy of TG4010 in combination with various chemotherapy regimens in this patient population were also assessed. The predictive value of the TrPAL biomarker, which was identified in an earlier Phase 2 study in advanced NSCLC patients (the TG4010.09 study), was assessed by comparing progression-free survival (PFS) between the two arms in two subgroups of patients according to their TrPAL level (normal or high) at the time they entered the trial (baseline).

A total of 210 patients (170 normal TrPAL level, 40 high TrPAL level) were enrolled in the study, and the current analyses were conducted per protocol after 89 progression events had occurred in the normal TrPAL group. For the primary analysis, a patient's TrPAL level was determined using a threshold based on an assessment of TrPAL levels in healthy people, a so-called 'upper limit of normal' (ULN) threshold. The study did not meet its primary endpoint when the ULN threshold was used.