ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated, commercial-stage immunotherapy company, today announced that based on the Independent Data Monitoring Committee (IDMC) review of the interim data, the committee recommended that the study is adequately powered to detect the pre-specified clinically meaningful difference in complete response (CR) rate between the experimental arm (ANKTIVA + BCG) and the control arm (BCG alone) at the protocol-specified power, in the randomized QUILT-2.005 (NCT02138734) study. The QUILT-2.005 study was designed to detect the pre-specified difference in CR rate between ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) and BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease, based on its review of the planned interim analysis.

On February 26, 2026, ImmunityBio announced enrollment was complete in the pivotal randomized trial. By March 2026, 50% of enrolled patients were evaluable (N=183) for the primary efficacy endpoint. Upon reaching this pre-specified 50% evaluable threshold, a planned interim analysis by an IDMC was initiated per protocol to verify that the 366 patients enrolled to date provides sufficient statistical power to detect the pre-specified clinically meaningful difference in CR rate between the two arms.

Based on the IDMC review of the interim data, the committee recommended that no additional enrollment beyond N=366 is required and that the study is adequately powered to detect the pre-specified clinically meaningful difference in CR rate at the protocol-specified power.