ImmunityBio: CIML NK cells plus N-803 may induce tumor regression

ImmunityBio announced findings from a Phase 1 study showing that allogeneic cytokine-induced memory-like natural killer cells used in combination with ImmunityBio’s IL-15 superagonist N-803 may induce tumor regression associated with persistent CIML NK cell expansion in advanced head-and-neck cancer patients. The results indicate the potential for a new treatment approach for the disease in advanced cases that currently have extremely poor prognoses. The data from the proof-of-concept study were presented by Glenn J. Hanna, M.D., Medical Oncologist with Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School at the American Association for Cancer Research and the American Head and Neck Society joint conference in Montreal, July 7-8, 2023. This phase 1 single-center trial enrolled 10 patients with R/M HNC regardless of human papillomavirus status who had prior platinum chemotherapy and immunotherapy. Patients in cohort 1 received LD fludarabine and cyclophosphamide on days -6 to -2 prior to haploidentical CIML NK cell infusion on day 0 followed by N-803 starting on day +1 every 21-days for 4-doses. Patients in cohort 2 received the same regimen with a dose of lead-in ipilimumab on day -7. A total of 6 patients were treated in cohort 1 and 4 patients in cohort 2. The primary objective was safety and maximum tolerated dose of CIML NK cells. The secondary objective was objective response rate, progression-free survival, overall survival, and phenotypic expansion and function of adoptively transferred NK cells.