enGene presents 56% complete response rate for detalimogene in bladder cancer study
ENGN•ENGN•ENGN•ENGN•Detalimogene achieved a 56% complete response rate in 120 evaluable patients with BCG-unresponsive, high-risk non-muscle-invasive bladder cancer. enGene plans to initiate a biologics license application in the fourth quarter of 2026, targeting potential approval in 2027.
Detalimogene achieved a 56% complete response rate among 120 evaluable patients with BCG-unresponsive, high-risk non-muscle-invasive bladder cancer. Median response duration was 10.1 months, and an estimated 43% of responders maintained responses for at least 12 months.
enGene Therapeutics plans to initiate detalimogene’s biologics license application in the fourth quarter of 2026, targeting potential approval in 2027. Six-month data from the detalimogene-surfactant cohort are expected in mid-2027. Cash totaled $245.8 million as of October 31, 2026.
