ImmunityBio reports QUILT 3.078 primary endpoint not reached yet

ImmunityBio (IBRX) announced updated Phase 2 clinical results from QUILT 3.078, evaluating a chemotherapy-free combination immunotherapy regimen in patients with second-line recurrent or progressive glioblastoma, as well as patients treated under single-patient INDs across first- to third-line disease. Primary endpoint of QUILT-3.078 is overall survival; median overall survival has not yet been reached, with 19 of 23 enrolled patients alive as of January 22. Fourteen patients have evaluable data, with the longest survival from time of disease recurrence reaching 12 months to date and ongoing. Baseline mean absolute lymphocyte count among these 14 patients was 0.9 x 103/uL, confirming severe lymphopenia at enrollment. ALC increased within one treatment cycle, with mean ALC rising to greater than or equal to 1.4 x 103/uL. Immune competence was maintained, with statistically significant increases from baseline observed at all assessments through 20 weeks with Anktiva + CAR-NK ANKTIVA + CAR-NK demonstrated a manageable safety profile following a total of 219 doses administered to date, with three treatment-related serious adverse events reported among 41 GBM patients enrolled across QUILT-3.078 and single-patient INDs. Randomized controlled trials in both first line and second line glioblastoma are in development.