ImmunityBio Inc. (NASDAQ:IBRX) shares are up during Thursday’s premarket session as the company has completed enrollment in its pivotal randomized trial evaluating Anktiva plus Bacillus Calmette-Guérin (BCG) against BCG alone for treating non-muscle invasive bladder cancer.

85% Patients Maintain Complete Response

The trial, known as QUILT 2.005, has enrolled 366 patients ahead of schedule, with interim analysis indicating that 85% of those receiving Anktiva plus BCG maintained a complete response at six months, compared to 57% for BCG alone.

The company anticipates submitting a biologics license application (BLA) to the FDA by the fourth quarter of 2026 based on these promising results.

In addition, the interim analysis demonstrated a statistically significant improvement in the duration of complete response at nine months, with 84% of patients in the ANKTIVA ...