ImmunityBio Announces Oral Presentation of Phase 2/3 Clinical Trial Results of Patients with BCG-Unresponsive Bladder Cancer Carcinoma at the Upcoming American Urological Association’s Annual Meeting

On September 1, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported Karim Chamie, M.D., Associate Professor of Urology, UCLA Department of Urology, will be presenting the Phase 2/3 clinical results of IL-15 Superagonist N-803 with BCG in BCG-unresponsive bladder cancer at the American Urological Association’s Annual Meeting on Sept. 10th (Press release, ImmunityBio, SEP 1, 2021, View Source [SID1234587087]).

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Updated data will be presented as a follow-up to Dr. Chamie’s oral presentation at ASCO (Free ASCO Whitepaper) GU in February 2021 in which 72 subjects in Cohort A of the QUILT 3.032 trial were evaluated. Eighty-one subjects are now fully enrolled in Cohort A and evaluable with median follow-up of over 20 months.

The full oral presentation, titled "PD09-05: Phase 2/3 clinical results of IL-15RαFc superagonist N-803 with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in-situ (CIS) patients," will be available in the Events section of ImmunityBio’s Investor Relations website on Friday, Sept. 10 at 10:10 a.m. PDT.

QUILT 3.032 is an open-label, three cohort multicenter Phase 2/3 study of intravesical BCG plus Anktiva (N-803) in patients with BCG-unresponsive high-grade NMIBC (NCT03022825) and was opened in 2017. The primary endpoint for Cohort A of this Phase 2/3 study is incidence of complete response (CR) of CIS at any time. The FDA had granted Fast Track Designation to the pivotal trial based on Phase I data. In December 2019, the FDA granted ImmunityBio Breakthrough Therapy Designation based on interim Phase 2 data indicating the primary endpoint of the trial was already met.