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• W4295817386 abstract "BackgroundIn a randomized controlled pivotal phase III pre-surgery administration of investigational proinflammatory biologic (LI) with CIZ (single low dose cyclophosphamide IV, indomethacin (po tid) and Zinc (po, daily) multivitamins + Standard of Care (SOC) to oral and soft-palate SCCHN subjects, resulted in significantly prolonged overall survival (OS) in the NCCN Guidelines defined low risk (LR) intent to treat (ITT) population vs SOC alone (NCT01265849).MethodsAvailable samples (453 ITT; 210 LR ITT) meeting entry criteria (AJCC Stage III/IVa OSCC, soft-palate SCCHN, Tx naïve) randomized 3:1:3 to Tx arms LI (+/- CIZ) + SOC or SOC alone. LI was injected 200IU peritumorally and 200IU peri-lymphatically daily, 3-weeks before surgery. All study subjects were to receive SOC (per NCCN, LR RTx, high risk CRTx post-surgery). Follow-up was comparable (56-57 months median per Tx group). Tumor HP samples were stained/quantitated for 20 biomarkers (5 tumor cell, 15 tumor microenvironment), 2 ratios, and 14 marker combinations prospectively defined, including low/high thresholds for each biomarker, ratio; combinations defined as +ve or -ve. Defined prospective interactions models (all subjects) allowed three-way interactions assessment for risk groups, biomarker/combination level and Tx, to analyze Tx efficacy for OS, PFS, LRC outcomes using proportional hazard models.ResultsTable: 128PProportion statistically significant, p<0.05Overall (n=453)Low Risk (n=210)Overall survival26/18821/94Progression free survival17/18816/94Local regional control18/18817/94Totals61/564 (10.8%>>2.5%)54/282 (14.7%>>2.5%)All advantages favored LI+CIZ+SOC vs SOC (only seen in LR) Open table in a new tab ConclusionsEfficacy (OS, PFS, LRC) was seen for multiple biomarkers (tumor: p16, PDL1, TME: CD4, CD8, CD3, FOXP3, CD20, CD68, CD163, CD1A, immune cells: PD1, CTLA4, PDL1, and CD25), ratios (CD4/CD8, CD8/FOXP3), and pre-defined combinations confirm and support LI OS efficacy.Clinical trial identificationProtocol: CS001P3, 30June2010; NCT01265849.Legal entity responsible for the studyCEL-SCI Corporation.FundingCEL-SCI Corporation.DisclosureJ. Timar: Other, Institutional, Principal Investigator, Relationship is for contract research: CEL-SCI. E. Talor: Financial Interests, Personal and Institutional, Full or part-time Employment, Including Stocks/Shares: CEL-SCI. P. Lavin: Other, Institutional, Advisory Role, Including Funding: CEL-SCI. A. Kiss: Other, Institutional, Principal Investigator, Relationship is for contract research: CEL-SCI. D. Markovic: Other, Institutional, Other, Relationship is for contract research: CEL-SCI. J. Cipriano: Financial Interests, Personal and Institutional, Full or part-time Employment, Including Stocks/Shares: CEL-SCI. All other authors have declared no conflicts of interest. BackgroundIn a randomized controlled pivotal phase III pre-surgery administration of investigational proinflammatory biologic (LI) with CIZ (single low dose cyclophosphamide IV, indomethacin (po tid) and Zinc (po, daily) multivitamins + Standard of Care (SOC) to oral and soft-palate SCCHN subjects, resulted in significantly prolonged overall survival (OS) in the NCCN Guidelines defined low risk (LR) intent to treat (ITT) population vs SOC alone (NCT01265849). In a randomized controlled pivotal phase III pre-surgery administration of investigational proinflammatory biologic (LI) with CIZ (single low dose cyclophosphamide IV, indomethacin (po tid) and Zinc (po, daily) multivitamins + Standard of Care (SOC) to oral and soft-palate SCCHN subjects, resulted in significantly prolonged overall survival (OS) in the NCCN Guidelines defined low risk (LR) intent to treat (ITT) population vs SOC alone (NCT01265849). MethodsAvailable samples (453 ITT; 210 LR ITT) meeting entry criteria (AJCC Stage III/IVa OSCC, soft-palate SCCHN, Tx naïve) randomized 3:1:3 to Tx arms LI (+/- CIZ) + SOC or SOC alone. LI was injected 200IU peritumorally and 200IU peri-lymphatically daily, 3-weeks before surgery. All study subjects were to receive SOC (per NCCN, LR RTx, high risk CRTx post-surgery). Follow-up was comparable (56-57 months median per Tx group). Tumor HP samples were stained/quantitated for 20 biomarkers (5 tumor cell, 15 tumor microenvironment), 2 ratios, and 14 marker combinations prospectively defined, including low/high thresholds for each biomarker, ratio; combinations defined as +ve or -ve. Defined prospective interactions models (all subjects) allowed three-way interactions assessment for risk groups, biomarker/combination level and Tx, to analyze Tx efficacy for OS, PFS, LRC outcomes using proportional hazard models. Available samples (453 ITT; 210 LR ITT) meeting entry criteria (AJCC Stage III/IVa OSCC, soft-palate SCCHN, Tx naïve) randomized 3:1:3 to Tx arms LI (+/- CIZ) + SOC or SOC alone. LI was injected 200IU peritumorally and 200IU peri-lymphatically daily, 3-weeks before surgery. All study subjects were to receive SOC (per NCCN, LR RTx, high risk CRTx post-surgery). Follow-up was comparable (56-57 months median per Tx group). Tumor HP samples were stained/quantitated for 20 biomarkers (5 tumor cell, 15 tumor microenvironment), 2 ratios, and 14 marker combinations prospectively defined, including low/high thresholds for each biomarker, ratio; combinations defined as +ve or -ve. Defined prospective interactions models (all subjects) allowed three-way interactions assessment for risk groups, biomarker/combination level and Tx, to analyze Tx efficacy for OS, PFS, LRC outcomes using proportional hazard models. ResultsTable: 128PProportion statistically significant, p<0.05Overall (n=453)Low Risk (n=210)Overall survival26/18821/94Progression free survival17/18816/94Local regional control18/18817/94Totals61/564 (10.8%>>2.5%)54/282 (14.7%>>2.5%)All advantages favored LI+CIZ+SOC vs SOC (only seen in LR) Open table in a new tab All advantages favored LI+CIZ+SOC vs SOC (only seen in LR) ConclusionsEfficacy (OS, PFS, LRC) was seen for multiple biomarkers (tumor: p16, PDL1, TME: CD4, CD8, CD3, FOXP3, CD20, CD68, CD163, CD1A, immune cells: PD1, CTLA4, PDL1, and CD25), ratios (CD4/CD8, CD8/FOXP3), and pre-defined combinations confirm and support LI OS efficacy. Efficacy (OS, PFS, LRC) was seen for multiple biomarkers (tumor: p16, PDL1, TME: CD4, CD8, CD3, FOXP3, CD20, CD68, CD163, CD1A, immune cells: PD1, CTLA4, PDL1, and CD25), ratios (CD4/CD8, CD8/FOXP3), and pre-defined combinations confirm and support LI OS efficacy." @default.
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• W4295817386 date "2022-09-01" @default.
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• W4295817386 title "128P Histopathology (HP) biomarkers confirm leukocyte interleukin injection (LI) treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN) the IT-MATTERS study" @default.
• W4295817386 doi "https://doi.org/10.1016/j.annonc.2022.07.160" @default.
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