Biomarkers of neoadjuvant Multikine (LI) treatment outcome in locally advanced head & neck carcinoma (ESTRO 2023)
Purpose or Objective In a Phase 3, randomized, controlled study, neoadjuvant administration of investigational proinflammatory biologic Multikine (LI,Leukocyte interleukin injection) with CIZ (single low dose cyclophosphamide IV, indomethacin (po tid) and Zinc (po, daily) multivitamins + Standard of Care (SOC) to oral and soft-palate squamous cell carcinoma (SCCHN) subjects, resulted in significantly prolonged overall survival (OS) in the NCCN defined low risk (LR) intent to treat (ITT) population vs SOC alone (IT-MATTERS Study, NCT01265849). 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 combinations proved to be predictive. LI + Surgery + RTx prolongs OS in SCCHN patients with no new Tx options in decades.