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Abstract
IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3?weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10?days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n?=?39), and multiplex immunohistology (n?=?54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm2 were used to characterize immune responders (IR).Regimen 1 was associated with significant increases in CD8+ infiltrates (p?=?0.01) compared to Regimen 2. In p16 negative cancers (n?=?26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p?=?0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p?=?0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p?=?0.11).The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).
View details for DOI 10.1016/j.oraloncology.2020.104928
View details for Web of Science ID 000596294900016
View details for PubMedID 32738599