Clinical TrialMay 7, 2026, 07:17 AM
enGene LEGEND Trial Shows 54% CR Rate; 12-Month KM Estimate 25%
AI Summary
enGene Therapeutics announced updated interim results from the pivotal cohort of its Phase 2 LEGEND trial for detalimogene voraplasmid in high-risk, BCG-unresponsive NMIBC patients. The trial showed a 54% complete response (CR) rate at any time and a 43% CR rate at six months, with a low progression rate to muscle-invasive disease (3.2%). However, the Kaplan-Meier estimate for the 12-month CR rate was 25%, which the CEO noted was "not what we hoped." The company also amended the employment agreement for Dr. Hussein Sweiti, increasing his base salary to $561,750 and annual bonus opportunity to 40%.
Key Highlights
- LEGEND Phase 2 trial showed a 54% complete response (CR) rate at any time (N=124).
- The 6-month CR rate was 43% (N=121) in high-risk, BCG-unresponsive NMIBC patients.
- Kaplan-Meier estimate for 12-month CR rate was 25%.
- Low rate of progression to muscle-invasive or advanced disease was 3.2%.
- Detalimogene was generally well tolerated, with 55% of patients experiencing treatment-related adverse events (TRAEs), mostly mild.
- Dr. Hussein Sweiti's annual base salary increased to $561,750 with a 40% annual bonus opportunity.
- Sweiti's employment agreement revised to allow resignation with 5 business days' notice after June 1, 2026, while retaining severance.
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