Shots:

• The P-II/III (QUILT 3.032) trial evaluating N-803 + BCG vs BCG alone in adults with NMIBC CIS with/out Ta/T1 papillary disease
• The trial met its 1EPs in high-risk carcinoma in situ cohort i.e., the therapy showed a 71% CR rate with an m-DoR was 26.6mos., CR rate (53%) @24mos., Kaplan–Meier–estimated probability of avoiding cystectomy and disease-specific survival was 89.2% & 100%
• The trial also met its 1EPs in BCG-unresponsive high-grade Ta/T1 papillary NMIBC i.e., N-803 + BCG showed a Kaplan–Meier–estimated DFS rate was 55.4% @12mos. with m-DFS of 19.3mos. The results were published in the NEJM. The BLA of N-803 + BCG is currently under the US FDA’s review for NMIBC CIS with an anticipated PDUFA date of May 23, 2023

Ref: Businesswire  | Image: ImmunityBio