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enGene to Initiate a BLA Submission for Detalimogene by Year End and Reports New Data from LEGEND Trial Pivotal Cohort 1 in BCG-Unresponsive NMIBC

ENGN
  • Updated pivotal Cohort 1 data from the Phase 2 LEGEND trial shows improved efficacy endpoints for detalimogene voraplasmid as of the October 29, 2026 cutoff.
  • The primary endpoint of complete response (CR) at any time increased to 56% from 54% in the April 2026 analysis.
  • The preliminary Kaplan-Meier estimate for duration of response (DoR) ≥ 12 months improved to 43% from 25%.
  • The preliminary median duration of response increased to 10.1 months from 8.6 months.
  • The landmark 12-month CR rate rose to 24% from 13%.
  • 97% of efficacy-evaluable patients remained free from progression to muscle-invasive or metastatic bladder cancer.
  • 86% of all efficacy-evaluable patients & 96% of responders remain free from cystectomy.
  • The drug demonstrated a favorable tolerability profile with only 2% of patients experiencing a serious treatment-related adverse event (TRAE).
  • No Grade 4 or Grade 5 TRAEs were reported, & TRAEs leading to dose discontinuation or interruption were rare.
  • A positive pre-BLA meeting with the FDA resulted in alignment on the efficacy evaluable population for the planned Biologics License Application.
  • enGene expects to initiate the BLA submission by year-end 2026 & aims to complete it in the first half of 2027, with potential approval in 2027.
  • Detalimogene is a non-viral plasmid gene therapy designed for easy integration into community urology practices.
  • A conference call & webcast regarding these updates is scheduled for November 11, 2026, at 4:30 p.m. ET.
  • The pivotal cohort included 125 patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.