ImmunityBio completed the database lock for its registrational trial of ANKTIVA plus BCG in 366 patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC). The milestone ends data collection and verification, clearing the way for final analysis.
The company expects to report topline results in November 2026. After analyzing the data, ImmunityBio plans to submit a supplemental Biologics License Application (sBLA) to the FDA in the fourth quarter of 2026.
If successful, the trial could support expanding ANKTIVA’s approved use to an earlier-stage, larger patient population.