TILScore-Guided TIL Therapy Produces 33% ORR in Checkpoint-Refractory Solid Tumors

TILScore is an in situ transcriptomic biomarker used to select a metastasis for autologous TIL harvest and “reactive-enriched” manufacturing before lymphodepletion, TIL infusion, and high-dose IL-2. In a single-center Phase 2 Bayesian basket trial (NCT03935893) of heavily pretreated immunotherapy-resistant solid tumors, 19 patients were treated and 18 were evaluable, with ORR 33% overall, including 50% in PDAC (3/6; 1 CR, 2 PR) and 100% in peritoneal mesothelioma (2/2; 1 CR, 1 PR). AEs were consistent with lymphodepletion/IL-2, with no grade 5 events, and TILScore correlated with response (AUC 0.806; p=0.041).