ImmunityBio Says Phase 2 Bladder Cancer Trial Has ‘Statistical Power’ – Anktiva-BCG Advances Toward Filing

ImmunityBio (IBRX) said on Thursday that its QUILT-2.005 clinical trial evaluating Anktiva plus Bacillus Calmette-Guérin (BCG) in patients with BCG-naïve non-muscle invasive bladder cancer remains on track for final analysis and a supplemental regulatory filing in 2026.

The Independent Data Monitoring Committee (IDMC) reviewed interim data from 183 evaluable patients, about half of the 366 participants enrolled in the study. The committee confirmed the trial has sufficient statistical power to detect a meaningful difference in complete response rates between the Anktiva plus BCG combination and BCG alone.

Based on the review, the committee concluded that no additional patient enrollment is required. ImmunityBio said the results support continued progress toward a supplemental Biologics License Application (BLA) submission planned for later this year.

IBRX stock was down around 2% in pre-market trading, after closing nearly 9% higher in the previous session.

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