enGene to initiate a BLA submission for detalimogene by year end
ENGN•enGene said it will initiate a biologics license application submission for detalimogene by year end and reported updated LEGEND trial data, including a 56% complete response rate at any time and 2% serious treatment-related adverse events.
1. Updated trial data
enGene reported improvements across all efficacy endpoints in pivotal cohort 1 of the LEGEND trial in BCG-unresponsive non-muscle-invasive bladder cancer compared with its April 2026 data analysis. Complete response at any time improved to 56%, and serious treatment-related adverse events were reported in 2% of patients.
