79P GPC3-targeted ARTEMIS T cell therapy in advanced hepatocellular carcinoma: ARYA-3 trial phase I results

Results: Median OS varied across treatment arms (A: 5.3, B: 11.2, C: 8, D: 20.7 months).The highest immune-related disease control rate (irDCR) occurred in Arm D (57%), with positive DTH in 83% of Arm D patients and in 56% of those treated with IFN-.Baseline profiling indicated that high CCL2, IL-4, VEGF, PMN-MDSCs, and PD-L1 + non-classical monocytes was associated with shorter irPFS.IFN- pre-treatment was associated with reduced CCL2 and PD-L1 + non-classical monocytes.Longitudinal analysis revealed temporal trends between pre-and post-vaccination in cytokines (CXCL10, IL-2, IL-8, VEGF), blood counts (monocytes, LMR), and T-cell subsets.No significant differences emerged in the percentage of IFN- + specific-T cells or clinical endpoints by IFN- status.Conclusions: DC vaccination was safe and immunogenic in advanced melanoma, with the best survival and immune-related disease control observed in the DCvax-alone arm.Baseline CCL2, IL-4, VEGF, and PD-L1 + non-classical monocytes emerged as potential outcome biomarkers.Dynamic immune changes were induced by DCvax, but no evidence of improved clinical outcomes was observed. Clinical trial identification: EudraCT