Clinical TrialNov 12, 2026, 06:16 AM
enGene to Initiate BLA for Detalimogene; Reports Improved Trial Data
AI Summary
enGene Holdings Inc. announced updated results from its Phase 2 LEGEND trial of detalimogene for BCG-unresponsive NMIBC, showing improved efficacy across key endpoints. The company plans to initiate a Biologics License Application (BLA) submission by year-end 2026, following alignment with the FDA. Detalimogene demonstrated a 56% CR rate at any time and a 43% estimated DoR of >= 12 months, with a favorable safety profile. Additionally, the company provided preliminary financial information for the fiscal year ended October 31, 2026, expecting to report approximately $245.8 million in cash, cash equivalents, and marketable securities.
Key Highlights
- Detalimogene achieved a 56% Complete Response (CR) rate at any time in pivotal Cohort 1.
- The median follow-up for responders increased to 12.0 months, with a 43% estimated Duration of Response (DoR) of >= 12 months.
- A landmark 12-month CR rate improved to 24% from 13% in updated data.
- The company reported a favorable tolerability profile with only 2% of patients experiencing a serious treatment-related adverse event (TRAE).
- enGene plans to initiate a Biologics License Application (BLA) submission for detalimogene by year-end 2026.
- The company expects preliminary financial information for FY2026 to show approximately $245.8 million in cash, cash equivalents, and marketable securities as of October 31, 2026.
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