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enGene reports 56% complete response rate in pivotal detalimogene bladder cancer trial

PUBT·11/11/2026 21:03:36
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enGene reports 56% complete response rate in pivotal detalimogene bladder cancer trial
  • enGene reported updated Phase 2 LEGEND trial results for detalimogene in high-risk, BCG-unresponsive non-muscle-invasive bladder cancer.
  • Updated results showed improved efficacy as data matured, with durable responses and most patients remaining free from bladder removal.
  • Treatment-related adverse events were mainly mild or moderate; treatment discontinuations were rare, with no life-threatening or fatal treatment-related events reported.
  • A U.S. biologics license application submission is expected to begin by year-end 2026, with completion planned for the first half of 2027.
  • Potential FDA approval is anticipated in 2027, while commercial preparations target broad adoption across community urology practices.


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. enGene Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20261111573459) on November 11, 2026, and is solely responsible for the information contained therein.