ImmunityBio Inc. (NASDAQ: IBRX) announced that its pivotal clinical trial evaluating ANKTIVA plus BCG versus BCG alone in bladder cancer patients has sufficient statistical power to detect clinically meaningful differences between treatment arms.

The Independent Data Monitoring Committee reviewed interim data from the QUILT-2.005 trial and confirmed that the fully enrolled study of 366 patients is adequately powered to detect the pre-specified difference in complete response rates. The committee determined no additional enrollment is required.

The randomized Phase 2b trial evaluates ANKTIVA (nogapendekin alfa inbakicept-pmln) combined with Bacillus Calmette-Guérin versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer with carcinoma in situ. BCG-naïve patients are receiving BCG-based therapy for the first time, representing an earlier treatment stage than the BCG-unresponsive population for whom ANKTIVA currently holds FDA approval.

The interim analysis was conducted after 50% of enrolled patients (183 patients) became evaluable for the primary efficacy endpoint in March 2026. ImmunityBio completed enrollment in the trial in February 2026.

ANKTIVA is currently approved with BCG for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ in 34 countries and territories. The company plans to submit a supplemental Biologics License Application based on final data analysis in 2026.

The trial is designed to assess whether adding ANKTIVA to standard induction BCG improves complete response rates in patients with carcinoma in situ with or without papillary disease. ANKTIVA is a first-in-class IL-15 receptor agonist that activates natural killer cells and CD8+ T cells.