ImmunityBio (IBRX) announced that based on the Independent Data Monitoring Committee, IDMC, review of the interim data, the committee recommended that the study is adequately powered to detect the pre-specified clinically meaningful difference in complete response rate between the experimental arm and the control arm at the protocol-specified power, in the randomized QUILT-2.005 study. The QUILT-2.005 study was designed to detect the pre-specified difference in CR rate between ANKTIVA plus Bacillus Calmette-Guerin, BCG, and BCG alone in patients with BCG-naive non-muscle invasive bladder cancer, NMIBC, with carcinoma in situ, CIS, with or without papillary disease, based on its review of the planned interim analysis.
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