Biotechnology company enGene Holdings Inc (Nasdaq:ENGN) on Tuesday reported preliminary data from its Phase 2 LEGEND trial evaluating detalimogene in high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ.

The pivotal cohort enrolled 125 patients, exceeding its target by 25%, with 62 patients assessed at three months and 37 at six months. All patients included in this analysis were evaluated under LEGEND's amended protocol, which was designed to more closely align the trial with the American Urological Association's Guidelines and standard of care.

Results showed a 62% complete response (CR) rate at six months, 56% at three months, and 63% at any time. All five patients completing nine months maintained CR. The therapy demonstrated a favourable tolerability profile, with 42% of patients experiencing treatment-related adverse events, 1.6% requiring dose interruptions, and 0.8% discontinuing treatment.

Detalimogene's safety profile included mostly Grade 1/2 adverse events such as fatigue, dysuria, and bladder spasms, with three Grade 3 events but no Grade 4 or 5 events.

enGene anticipates a data update on the pivotal cohort in the second half of 2026.. The company plans to file a Biologics License Application (BLA) in the second half of 2026, with potential FDA approval in 2027.