enGene Therapeutics reports updated LEGEND trial data and plans BLA submission for detalimogene
enGene Therapeutics released new Phase 2 LEGEND trial results for its bladder‑cancer gene therapy detalimogene. The updated data show a 56% complete response rate and a 43% probability of response lasting at least 12 months, with a median response duration of 10.1 months. Safety remains favorable, with 59% of patients reporting any treatment‑related adverse event and only 4% experiencing Grade 3 events. The company said it will file a Biologics License Application by the end of 2026, targeting FDA approval in 2027.
Why it matters
If the BLA is approved, detalimogene could become the first non‑viral plasmid gene therapy for BCG‑unresponsive non‑muscle‑invasive bladder cancer, opening a new revenue stream for enGene. The trial’s improved efficacy and safety metrics may increase investor confidence ahead of the regulatory filing.
Key facts
- 1Complete response rate at any time was 56% (based on 120 efficacy‑evaluable patients). investing.com
- 2Preliminary Kaplan‑Meier estimate of duration of response ≥12 months increased to 43%. investing.com
- 3Median duration of response improved to 10.1 months. investing.com
- 459% of the 125 patients assessed for safety experienced at least one treatment‑related adverse event, mainly Grade 1/2. investing.com
- 54% of patients experienced Grade 3 treatment‑related adverse events; no Grade 4/5 events were reported. investing.com
- 6enGene expects to initiate BLA submission for detalimogene by year‑end 2026 and complete it in the first half of 2027. investing.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.