Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAR-210 · 2 trials · 1 indication
DFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ \[CIS\]), progression, or death due to any cause, whichever occurs first.
DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Group A: TAR-210 | EXPERIMENTAL | Participants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will be inserted over a treatment duration of approximately 2 years. |
| Group B: Mitomycin C (MMC) or Gemcitabine | ACTIVE_COMPARATOR | Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion. |
| Main Study: Group A: TAR-210 | EXPERIMENTAL | Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year. |
| Main Study: Group B: MMC or Gemcitabine | ACTIVE_COMPARATOR | Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year. |
| Substudy: Group A: TAR-210 | EXPERIMENTAL | Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year. |
| Substudy: Group B: MMC | ACTIVE_COMPARATOR | Participants in substudy Group B will receive intravesical MMC once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year. |
| Name | Type | Description |
|---|---|---|
| TAR-210 | DRUG | TAR-210 will be administered intravesically. |
| Mitomycin C | DRUG | MMC will be administered intravesically. |
| Gemcitabine | DRUG | Gemcitabine will be administered intravesically. |
| MMC | DRUG | MMC will be administered intravesically. |
Inclusion criteria: * Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded * H...
TAR-210 is an investigational small molecule being developed for the treatment of Non-Muscle Invasive Bladder Neoplasms, a type of bladder cancer. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
TAR-210 is being developed by Johnson & Johnson, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The company is currently conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy.
TAR-210 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. Two Phase 3 trials are currently recruiting participants to evaluate its effectiveness in treating Non-Muscle Invasive Bladder Neoplasms.
TAR-210 is being evaluated in two Phase 3 clinical trials. The first, NCT06319820, compares TAR-210 to single agent intravesical cancer treatment in 641 participants with bladder cancer. The second, NCT06919965, compares TAR-210 to intravesical chemotherapy in 220 participants with high-risk non-muscle-invasive bladder cancer.
TAR-210 is not FDA approved. It is an investigational drug currently in Phase 3 clinical trials. The trials are recruiting participants to study its safety and efficacy in treating Non-Muscle Invasive Bladder Neoplasms, but regulatory approval has not been granted.
TAR-210 is a small molecule therapeutic, but its specific molecular target has not been disclosed in available information. It is being studied in Phase 3 trials for Non-Muscle Invasive Bladder Neoplasms, with active-controlled trial designs comparing it to existing intravesical treatments.