enGene plans bladder cancer therapy filing after updated pivotal trial results
Image: Primary enGene says it expects to begin a U.S. approval application for its investigational bladder cancer gene therapy detalimogene by year-end 2026, following an FDA meeting that aligned the parties on the efficacy-evaluable population. It plans to complete the submission in the first half of 2027.
The company reported a 56% complete response rate at any time among 120 evaluable patients in the pivotal cohort of its ongoing Phase 2 LEGEND trial, up from 54% in April. The preliminary estimate of responses lasting at least 12 months rose to 43% from 25%. Nine patients were still awaiting that durability assessment; 2% of the 125 patients assessed for safety experienced a serious treatment-related adverse event.
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