Drugs / detalimogene voraplasmid
detalimogene voraplasmid
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04752722 | Apr 2021 → Jun 2026 overdue | bladder carcinoma in situ, superficial urinary bladder carcinoma | enGene, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-05-07 | enGene, Inc. | Results enGene Announces Updated Interim Results From LEGEND Pivotal Cohort engene.com ↗
These data, as of April 21, 2026, demonstrated that patients treated with detalimogene achieved a 54% complete response (CR) at any time and a 43% CR rate at six months. |
| 2025-12-02 | enGene, Inc. | Regulatory enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness engene.com ↗ |
| 2025-11-11 | enGene, Inc. | Results Detalimogene Demonstrates Improved Complete Response Rate of 62% at 6 Months engene.com ↗
62% CR rate at 6 months (n=37), with 4 patients having successfully converted to CR post reinduction; |
| 2025-09-11 | enGene, Inc. | Regulatory enGene Reports Third Quarter 2025 Financial Results and Provides Business Update engene.com ↗
Detalimogene granted Regenerative Medicine Advanced Therapy (RMAT) designation by FDA |
| 2025-06-25 | enGene, Inc. | Regulatory FDA Grants RMAT Designation for enGene’s Detalimogene, Enabling Potential for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer engene.com ↗ |
| 2024-09-26 | enGene, Inc. | Results Detalimogene Demonstrates 71% Complete Response Rate at Any Time in Preliminary Analysis of LEGEND Pivotal Cohort engene.com ↗
Today, the Company announced preliminary data from 21 patients assessed at three months, including 17 patients who were also assessed at six months, in the ongoing pivotal cohort of the LEGEND study. |
| 2023-02-14 | enGene, Inc. | Results enGene announces poster presentation containing interim Phase 1 clinical trial data at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium engene.com ↗
Interim Phase 1 results from enGene’s Phase 1/2 LEGEND study of intravesical EG-70 (detalimogene voraplasmid) demonstrate a 71% CR rate at three months in patients with high-grade non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) that is BCG-unresponsive |
| 2022-02-08 | enGene, Inc. | Results enGene Announces Positive Preliminary Phase 1/2 Data with EG-70 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer engene.com ↗
The results from LEGEND study to-date have shown that enGene’s novel intravesical monotherapy, EG-70, is safe and well tolerated, with encouraging clinical efficacy in high-grade NMIBC patients with CIS in whom BCG has failed. |
All press releases naming this drug 10 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | detalimogene voraplasmid | “50 mL of detalimogene voraplasmid (EG-70) at the RP2D” NCT04752722 ↗ |
| Known as | detalimogene | “intravesical administration of detalimogene (EG-70) in the bladder” NCT04752722 ↗ |
| Known as | Detalimogene voraplasmide | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095481 ↗ |
| Known as | Detalimogene voraplasmido | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095481 ↗ |
| Known as | EG-70 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04752722 ↗ |
| Route | Other | “intravesical administration” NCT04752722 ↗ |