enGene publishes presentation on LEGEND trial interim results
ENGN•enGene Therapeutics published interim results from the LEGEND pivotal cohort: detalimogene without surfactant achieved a 56% complete response rate among 120 efficacy-evaluable patients. The company plans to begin a biologics license application filing in the fourth quarter of 2026, with potential approval in 2027.
1. Interim trial results
Detal imogene without surfactant achieved a 56% complete response rate at any time among 120 efficacy-evaluable patients. An estimated 43% of patients had a response lasting at least 12 months, and median response duration was 10.1 months. Serious treatment-related adverse events affected 2% of patients, while 1% discontinued treatment because of treatment-related events.
2. Filing timeline
enGene Therapeutics plans to begin a biologics license application filing in the fourth quarter of 2026, with potential approval in 2027.
