enGene reports detalimogene shows complete response rate of 62% at 6 months

enGene (ENGN) Holdings reported additional preliminary data from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid, also known as detalimogene and previously EG-70, in high-risk, Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer patients with carcinoma in situ with or without concomitant papillary disease. Detalimogene’s preliminary data to date and differentiated profile continue to support the company’s planned Biologics License Application submission in the second half of 2026, the company stated. The preliminary analysis included 62 patients at 3 months and 37 patients at 6 months. All patients included in this analysis were evaluated under LEGEND’s amended protocol, which went into effect in the fourth quarter of 2024, and was designed to more closely align the LEGEND trial with the American Urological Association’s Guidelines and standard of care. Data from 62 patients enrolled under the amended protocol with at least one post-baseline disease assessment demonstrated: 63% complete response rate at any time; 56% CR rate at 3 months; 62% CR rate at 6 months, with 4 patients having successfully converted to CR post reinduction; and all 5 patients who completed the 9-month assessment had a CR. The company completed enrollment of 125 patients in the pivotal cohort, exceeding its target by 25%. Data from these patients demonstrated a favorable tolerability profile: 42% of patients experienced a treatment-related adverse event; 1.6% of patients experienced dose interruptions due to TRAEs; and 0.8% of patients experienced dose discontinuations due to TRAEs. “We are pleased to report an improved 6-month CR rate for patients being treated with detalimogene under our amended protocol,” said Hussein Sweiti, M.D., MSc, Chief Medical Officer. “With a competitive preliminary efficacy profile and potential for best-in-class tolerability and ease of use, we believe detalimogene could emerge as the first-line therapy for patients with high-risk, BCG-unresponsive NMIBC.”