Outcomes

The primary outcome measures were safety and immune response. Safety was assessed by reported adverse events during the entire 2-year study period. Immune response to TG01 was assessed by two different antigen-specific assays: (1) delayed-type hypersensitivity (DTH test), and (2) in vitro T-cell proliferation.

The DTH test (measured up to nine times per patient) is a test in the skin measuring the presence of activated T cells recognising TG01. TG01 was injected intradermally, and the DTH test considered positive if the area of the skin reaction (redness/induration) at the injection site 48 h after injection had an average diameter ≥ 5 mm.

The T-cell proliferation assay is an in vitro assay showing proliferation response of TG01-specific T cells. Blood sampling and peripheral blood mononuclear cell (PBMC) isolation were performed on day 1 (baseline), week 11, week 52 and at the end of the study for the main cohort, and on day 1, week 8, 4 weeks after the last chemotherapy injection, week 52 and at the end of the study for the modified cohort. T-cell responses were considered positive if the stimulation index (SI) was ≥ 2, indicating an increase in proliferation of TG01-specific T cells after stimulation with TG01 compared with unstimulated cells.

An immune responder was defined as having either a positive DTH response and/or positive T-cell proliferation.

Secondary outcome measures were DFS and OS at 1 and 2 years measured from the date of surgery. Patients still disease-free at the last computed tomography (CT) scan collected in the study were censored on the date of the last CT scan. Patients still alive when last contacted in the study were censored at the date of the last contact.

Exploratory endpoints included assessment of the relationship between KRAS status (in resected primary tumour) and survival outcomes, and changes in CA19-9 levels.