ImmunityBio (IBRX) announced new data from its ongoing QUILT 3.032 study. As of November, 100 patients with Bacillus Calmette-Guerin, or BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, or NMIBC CIS, have been treated with Anktiva in combination with BCG, achieving a 71% complete response rate. In these responders, the range of durable response extended to 54 months. This data update will be submitted to the European Medicines Agency in a marketing authorization application, or MAA, for Anktiva in the European Union, which is anticipated during Q4 2024. The QUILT 3.032 study is a single-arm, multicenter trial evaluating the safety and efficacy of Anktiva plus BCG in patients with BCG-unresponsive NMIBC CIS. The observed 71% CR rate aligns with previous findings reported in the New England Journal of Medicine and reinforces the therapeutic promise of this combination therapy.
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