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ImmunityBio Reports P-II/III (QUILT 3.032) Trial Results of N-803 + BCG for the Treatment of Bladder Cancer

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ImmunityBio Reports P-II/III (QUILT 3.032) Trial Results of N-803 + BCG for the Treatment of Bladder Cancer

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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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