Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EG-70 (phase 1)
EG-70 · 1 trial · 3 indications
The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.
Complete response rate will be measured by determining the number of patients without recurrence of disease.
The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.
| Arm | Type | Description |
|---|---|---|
| Phase 1 | EXPERIMENTAL | Dose escalation phase |
| Phase 2 | EXPERIMENTAL | Cohort 1: Recommended Phase 2 dose (RP2D) with eligible BCG-unresponsive NMIBC patients with CIS, up to 4 cycles of treatment with EG-70. Patients in Complete Response continue to Maintenance Treatment. Cohorts 2A, 2B and 3: RP2D with eligible high-risk NMIBC patients with CIS who are BCG-naïve, BCG-exposed (incompletely treated with BCG) or BCG-unresponsive HG Ta/T1 papillary disease without CIS |
| Phase 1 Substudy Surfactant Bladder Rinse | EXPERIMENTAL | BCG-unresponsive NMIBC patients with CIS, up to 4 cycles of treatment with EG-70. Patients in Complete Response continue to Maintenance Treatment. Bladder Rinse Cohort: a 5-minute bladder rinse prior to administration of RP2D of detalimogene voraplasmid (EG-70) with a shortened administration time of 30 minutes. |
| Name | Type | Description |
|---|---|---|
| EG-70 (phase 1) | DRUG | Patients will receive up to four cycles of EG-70 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes.One cycle lasts approximately 12 weeks and consists of either a 2-dose (Day 1 and Day 8) or 4-dose (Day 1, Day 8, Day 29 and Day 36) regimen. |
| EG-70 (phase 2) Master Protocol | DRUG | Under the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles, of EG-70 at the RP2D defined in Phase 1, administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes. One cycle lasts approximately 12 weeks. For Maintenance treatment 2 doses of EG-70 will be administered as a bladder instillation per 12-week cycle. |
| Surfactant Bladder Pre-Rinse and EG-70 (Substudy) | DRUG | Patients will receive via catheter a 50 mL volume of a 5-minute bladder rinse immediately prior to administration of 50 mL of detalimogene voraplasmid (EG-70) at the RP2D for 30 minutes. During the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles of the sudy intervention. One cycle lasts approximately 12 weeks. For Maintenance treatment, 2 doses of the study intervention will be administered as a bladder instillation per 12-week cycle. |
Inclusion Criteria: BCG-unresponsive Patients: 1. BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without coexisting papillary Ta/T1 tumors who are ineligible for or have elected not to undergo cystectomy, and have experienced CIS disease within 12 months of treatment where: adequate B...
EG-70 is an investigational therapy being developed for superficial bladder cancer, including non-muscle invasive bladder cancer with carcinoma in situ. It is being studied in patients whose disease is BCG-unresponsive, who are high-risk and incompletely treated with BCG, or who are BCG-naive.
EG-70 is being developed by enGene Holdings Inc., which trades under the ticker ENGN. The company is running the clinical program for the asset in non-muscle invasive bladder cancer.
EG-70 is in Phase 1 clinical development. It is investigational and is being evaluated in a single recruiting study, the LEGEND trial, which is enrolling an estimated 350 participants across multiple countries.
EG-70 is being studied in the LEGEND trial, registered as NCT04752722. The Phase 1 study is recruiting adults aged 18 and older of all sexes in the United States, Australia, Canada, France, Germany, Italy, South Korea, Spain, Taiwan, and the United Kingdom.
Yes, EG-70 (phase 1) refers to the same asset as EG-70. The parenthetical simply denotes the current Phase 1 stage of clinical development for enGene Holdings' bladder cancer candidate.
The LEGEND study enrolls patients with superficial bladder cancer, including non-muscle invasive bladder cancer with carcinoma in situ and non-muscle invasive bladder cancer more broadly. It includes BCG-unresponsive and high-risk patients incompletely treated with BCG, as well as BCG-naive patients.