# enGene plans bladder cancer therapy filing after updated pivotal trial results

_Published Thursday, November 12, 2026 at 11:19 PM EST · Science · Latest · Tier 2 — Notable_

![enGene plans bladder cancer therapy filing after updated pivotal trial results — Primary](https://static.biospace.com/dims4/default/d32393a/2147483647/strip/true/crop/1120x630+40+0/resize/1440x810!/quality/90/?url=https%3A%2F%2Fk1-prod-biospace.s3.us-east-2.amazonaws.com%2Fbrightspot%2Fcc%2F88%2Fa9fddaf440db946b77e1d45d2e26%2Fbiospace-5.png)

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.

## Sources

- [BioSpace](https://www.biospace.com/press-releases/engene-to-initiate-a-bla-submission-for-detalimogene-by-year-end-and-reports-new-data-from-legend-trial-pivotal-cohort-1-in-bcg-unresponsive-nmibc)

---
Canonical: https://techandbusiness.org/newswire/ob0VFM_Dxi9VCQLQ4ljuX1
Published: 2026-11-13T04:19:32.107Z
Story chronology: 2026-11-12T03:46:38.445Z
Retrieved: 2026-11-13T07:31:58.258Z
Publisher: Tech & Business (techandbusiness.org)