enGene Reports 62% Complete Response Rate at 6 Months in Phase 2 Bladder Cancer Trial

Reuters
2025.11.11 12:30
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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.