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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 ...

ImmunityBio, Inc. (IBRX) 
Company Research Source: Yahoo! Finance
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 once 50% of enrolled patients (N=183) in Cohort A were evaluable for the primary efficacy endpoint The IDMC reviewed the interim complete response data in 183 evaluable patients comparing ANKTIVA ® + BCG to BCG alone to assess whether the current enrollment is sufficient to detect the pre-specified clinically meaningful difference between treatment arms at the protocol-specified power and concluded that no additional enrollment is required CULVER CITY, Calif., March 26, 2026 BUSINESS WIRE Show less Read more
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