enGene Reports 62% Complete Response Rate at 6 Months in Phase 2 Bladder Cancer Trial
enGene Holdings Inc. reported a 62% complete response rate at 6 months in its Phase 2 LEGEND trial for detalimogene voraplasmid in high-risk, BCG-unresponsive non-muscle invasive bladder cancer patients. The trial included 62 patients at 3 months and 37 at 6 months, showing favorable tolerability with mostly Grade 1 or 2 adverse events. enGene plans to submit a Biologics License Application in the second half of 2026, pending further FDA discussions and additional data. Future updates on the trial are anticipated in the same timeframe.
enGene Holdings Inc. has announced additional preliminary data from the pivotal cohort of its ongoing Phase 2 LEGEND trial evaluating detalimogene voraplasmid (detalimogene, previously EG-70) in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS), with or without concomitant papillary disease. The preliminary analysis included 62 patients at 3 months and 37 patients at 6 months. Detalimogene demonstrated a complete response rate of 62% at 6 months. The company reported that detalimogene’s overall tolerability profile was favorable, with most treatment-related adverse events being Grade 1 or 2 in severity. enGene plans to submit a Biologics License Application (BLA) in the second half of 2026, pending further discussions with the FDA and the accumulation of sufficient 12-month complete response data. The company anticipates providing a data update on the LEGEND trial’s pivotal cohort in the second half of 2026. Results from the trial were presented in the company’s announcement and further updates are planned for the future. 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 Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251111033184) on November 11, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
