Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-17000139, Gemcitabine-Releasing Intravesical System, Gemcitabine-Releasing Intravesical System (GemRIS)
TAR-200 · 5 trials · 3 indications
DFS will be measured as the time from randomization to the time of the first recurrence of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[high grade (HG) Ta, any T1 or carcinoma in situ (CIS)\], progression, or death due to any cause, whichever occurs first.
EFS is defined as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with carcinoma In-situ (CIS), persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: an increase of stage from Ta to T1 or from CIS to T1 or progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurs first.
pCR was defined as percentage of participants who achieved complete pathologic response. Complete pathologic response is defined as ypT0N0 (no evidence of disease) as assessed by pathologic evaluation on radical cystectomy (RC) specimen. pCR was determined by central pathologic review.
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.
DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause.
An Adverse Event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.
| Arm | Type | Description |
|---|---|---|
| Group A: TAR-200 | EXPERIMENTAL | Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase. |
| Group B: Mitomycin C (MMC) or Gemcitabine | ACTIVE_COMPARATOR | Participants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase. |
| Treatment Group A: TAR-200 + Cetrelimab | EXPERIMENTAL | Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab. |
| Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture | ACTIVE_COMPARATOR | Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance). |
| Treatment Group C: TAR-200 Alone | EXPERIMENTAL | Participants will receive intravesical TAR-200 alone once Q3W. |
| Cohort 1: TAR-200 + Cetrelimab | EXPERIMENTAL | Participants will receive TAR-200 in combination with cetrelimab. |
| Cohort 2: Cetrelimab | EXPERIMENTAL | Participants will receive cetrelimab. |
| Cohort 1: TAR-200 and Cetrelimab | EXPERIMENTAL | TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months). |
| Cohort 2: TAR-200 | EXPERIMENTAL | TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). |
| Cohort 3: Cetrelimab | EXPERIMENTAL | Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months). |
| Cohort 4: TAR-200 (Participants with Papillary Disease only) | EXPERIMENTAL | TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). |
| Participants Ineligible for Radical Cystectomy | EXPERIMENTAL | Participants will receive the TAR-200 transuretherally on Day 0 in to the bladder through an Inserter and gradually releases gemcitabine during the 21-day indwelling period before being removed on Day 21 via flexible or rigid cystoscopy. Participants will undergo an 84-day induction period comprised of four consecutive 21-day dosing cycles. Participants may undergo 21 day cycle every 3 months for a maximum of 3 cycles as maintenance (Up to 14 months). Each TAR-200 system will be removed at 21 days after insertion. |
| Name | Type | Description |
|---|---|---|
| TAR-200 | DRUG | Participants will receive TAR-200 intravesically. |
| Mitomycin C | DRUG | Participants will receive MMC intravesically. |
| Gemcitabine | DRUG | Participants will receive gemcitabine intravesically. |
| Cetrelimab | BIOLOGICAL | Cetrelimab will be administered. |
| BCG Vesiculture | BIOLOGICAL | BCG will be administered intravesically. |
Inclusion Criteria: * Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[defined as high-grade Ta or any T1, no carcinoma in situ (CIS)\] * Participants with var...
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TAR-200 is an investigational therapy being studied for bladder cancer, including non-muscle invasive bladder neoplasms and urinary bladder neoplasms. It is being developed for patients with high-risk non-muscle invasive bladder cancer, including those who are BCG-naive or who have recurrent disease after BCG, as well as muscle-invasive urothelial carcinoma of the bladder.
TAR-200 is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company is the sponsor of the clinical trials evaluating TAR-200 in bladder cancer.
TAR-200 is in Phase 3 clinical development. Two Phase 3 trials are ongoing, and two Phase 2 trials have been completed or are active. The Phase 3 program includes a study of TAR-200 versus intravesical chemotherapy and a study of TAR-200 alone or with cetrelimab versus BCG.
TAR-200 is being evaluated in several clinical trials. Phase 3 studies include NCT06211764, comparing TAR-200 to intravesical chemotherapy in recurrent high-risk non-muscle invasive bladder cancer after BCG, and NCT05714202, comparing TAR-200 with or without cetrelimab to BCG in BCG-naive patients. Phase 2 studies include NCT04919512 and NCT04640623.
TAR-200 is not approved by the FDA. It is an investigational therapy still in clinical development. The FDA has granted TAR-200 Breakthrough Therapy and Priority Review designations, which are intended to expedite the development and review of drugs for serious conditions.