ImmunityBio confirms QUILT-2.005 trial remains adequately powered at N=366; supplemental BLA submission stays on track for 2026

Reuters03-26

ImmunityBio confirms QUILT-2.005 trial remains adequately powered at N=366; supplemental BLA submission stays on track for 2026

An Independent Data Monitoring Committee review of interim data from the randomized QUILT-2.005 trial found the study is adequately powered to detect a pre-specified clinically meaningful difference in complete response rate between ANKTIVA plus BCG and BCG alone in BCG-naïve NMIBC patients with CIS with or without papillary disease.
At the interim analysis threshold, 50% of enrolled patients were evaluable (N=183) for the primary endpoint, and the committee recommended no additional enrollment beyond N=366.
ImmunityBio said enrollment in QUILT-2.005 is complete and a supplemental BLA submission based on final data analysis is planned for 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immunitybio Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260326666809) on March 26, 2026, and is solely responsible for the information contained therein.

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