ImmunityBio bladder cancer trial meets statistical power requirements
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ImmunityBio Confirms Statistical Power in Pivotal Randomized BCG-Naïve NMIBC Trial to Detect Clinically Meaningful Differences Between ANKTIVA® Plus BCG Versus BCG Alone; Supplemental BLA Submission
March 26, 2026 7:30 AM EDTThe QUILT-2.005 randomized clinical trial is on track for final analysis and supplemental Biologics License Application (BLA) submission in 2026 for the BCG-naïve NMIBC carcinoma in situ with or without papillary indication with no additional enrollment required
The Independent Data Monitoring Committee (IDMC) confirmed that the fully enrolled study (N=366) is adequately powered to detect the pre-specified difference in complete response rate between the experimental and control arms, and that no additional enrollment is required
A planned interim analysis was conducted by the IDMC per the protocol... More
