Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Erdafitinib Intravesical Delivery System, JNJ-42756493
TAR-210 · 7 trials · 9 indications
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.
Number of participants with DLT will be assessed. The DLTs are specific adverse events related to erdafitinib intravesical delivery system and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Overall CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy.
RP2D will be determined based on pharmacodynamics, biomarker response or clinical response, as well as the incidence rate and nature of the toxicities observed.
Objective response based on assessment of confirmed Complete response (CR) or partial response (PR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) for HCC. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.
The maximum tolerated dose as determined in Part 1 of the study will be used as the recommended dose for Part 2, 3 and Part 4.
| 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. |
| Dose Escalation: Erdafinitib Intravesical Delivery System | EXPERIMENTAL | Participants with bladder cancer and fibroblast growth factor receptor (FGFR) mutations or fusions will receive erdafitinib intravesical delivery system and study will evaluate 2 dose levels of erdafitinib. Participants with a complete response (CR) may continue to receive treatment up to a duration of 1 year as long as there is no disease recurrence or progression, intolerable toxicity or withdrawal of consent. |
| Part 1: Dose Escalation | EXPERIMENTAL | Participants with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D\[s\]) for Part 2. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants in each of 5 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1. |
| Part 3: RP2D Dose Expansion | EXPERIMENTAL | Participants in 2 of the disease-specific NMIBC cohorts (cohorts 1 and 3) may be enrolled at RP2D to determine the safety, evaluate PK and preliminary clinical activity. |
| Part 4: Phase 2 Expansion | EXPERIMENTAL | Participants with recurrent IR-NMIBC will be enrolled in this part to further evaluate the safety, efficacy, and PK of the selected RP2D. |
| Part 1: Dose Escalation and Part 2: Dose Expansion | EXPERIMENTAL | Part 1: First, participants will receive 8 milligram (mg) (starting dose) tablet of JNJ-42756493 (erdafitinib) orally once daily from Day 1 to 7, then Day 15 to 21 of 28 days cycle or 8 mg orally once daily from Day 1 to 21 of 28 days cycle (intermittent dosing). After recommended Phase 2 dose (RP2D) is identified, enrollment of continuous dosing schedule will be open, starting at 8mg. In this cohort, participants will receive 8mg (starting dose) tablet of JNJ42756493 (erdafitinib) orally once daily from Day 1 to Day 28 in a 28-day cycle. Dose of the study medication will be escalated sequentially till the dose limiting toxicity is achieved to determine RP2D. Part 2: Participants will receive RP2D JNJ-42756493 (erdafitinib) dose determined in Part 1. Participants who are tolerating study drug treatment and achieve clinical responses or stable disease will continue to receive study drug at the same dose until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Part 1: Dose Escalation (Daily Dosing) | EXPERIMENTAL | Dose escalation of JNJ-42756493 is to occur until a dose at which \<33 percent of participants experience a dose-limiting toxicity, the maximum concentration of JNJ-42756493 is less than the protocol-defined cardiovascular threshold, and JNJ-42756493 is biologically active. Participants will receive study drug once day on Day 1 of Cycle 1 followed by a 2-day drug-free period (Days 2 and 3 of Cycle 1) and continues throughout the 21 day cycle. For all subsequent cycles once a day for 21 days. |
| Part 1: Dose Escalation (Intermittent Dosing) | EXPERIMENTAL | Intermitting dosing regimen will be 28 days (7 days on and 7 days off). Participants will receive JNJ-42756493 on Days 1 to 7 and Days 15 to 21 of each cycle; JNJ-42756493 will not be administered on Days 8 to 14 and Days 22 to 28 of each cycle. |
| Part 1 | EXPERIMENTAL | Dose Escalation, Part 1: Participants will be enrolled in sequential cohorts to determine recommended Phase 2 doses (RP2D). |
| Part 2 | EXPERIMENTAL | Dose Confirmation, Part 2: Tumor biopsy cohorts will confirm RP2D. |
| Part 3, Cohort A | EXPERIMENTAL | First dose expansion, Part 3: Participants with squamous non-small cell lung cancer. |
| Part 3, Cohort B | EXPERIMENTAL | First dose expansion, Part 3: Participants with small cell lung cancer. |
| Part 3, Cohort C | EXPERIMENTAL | First dose expansion, Part 3: Participants with breast cancer. |
| Part 3, Cohort D | EXPERIMENTAL | First dose expansion, Part 3: Participants with solid tumors (consisting of one of the following: gastric, head and neck, lung adenocarcinoma, urothelial, glioblastoma multiforme \[GBM\], ovarian or prostate). |
| Part 4, Cohort E | EXPERIMENTAL | Second dose expansion, Part 4: Participants with non-small cell lung cancer. |
| Part 4, Cohort F | EXPERIMENTAL | Second dose expansion, Part 4: Participants with solid tumors (consisting of one of the following: breast, urothelial, GBM). |
| 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. |
| Erdafitinib Intravesical Delivery System | DRUG | Erdafitinib intravesical delivery system will be administered. |
| JNJ-42756493 (erdafitinib) | DRUG | Part 1: Participants will receive 8 mg tablet once daily from Day 1 to 7, and then Day 15 to 21 of 28 days cycle or 8 mg orally once daily of 28 days cycle up to the maximum tolerated dose in order to determine the recommended Phase 2 dose. Part 2: Recommended Phase 2 JNJ-42756493 (erdafitinib) dose determined in Part 1. |
| Part 1: JNJ-42756493 | DRUG | JNJ-42756493 dose escalation starting at dose of 2 mg orally daily for 21-day cycles and 28 day cycles Intermitting dosing regimen (7 days on and 7 days off) up to the maximum tolerated dose in order to determine the recommended Phase 2 dose. |
| Part 2: JNJ-42756493 | DRUG | Recommended Phase 2 JNJ-42756493 dose determined in Part 1 administered orally for 28-days cycles (Intermitting dosing regimen). |
| JNJ-42756493: Part 1 | DRUG | Participants will receive 0.5 mg (starting dose) capsule of JNJ-42756493 orally (by mouth) once daily on Day 1 of Cycle 1. Dose of the study medication will be escalated sequentially till the dose limiting toxicity is achieved to determine the recommended part 2 doses (RP2D). |
| JNJ-42756493: Part 2 | DRUG | Participants will receive JNJ-42756493 at the RP2D or below RP2D (maximum tolerated dose from Part 1) orally once daily on a 21 days cycle to confirm RP2D (in Part 2). |
| JNJ-42756493: Part 3 | DRUG | Participants will receive JNJ-42756493 at first RP2D of 9 mg daily in Part 3 orally once daily on a 21 days cycle. |
| JNJ-42756493: Part 4 | DRUG | Participants will receive JNJ-42756493 second RP2D of 10 mg intermittent dosing in Part 4 (with option to increase to 12 mg intermittent dosing based on phosphate level), orally on an intermittent schedule of daily for 7 days followed by 7 days off with a 28-day cycle. |
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 intravesical drug delivery system that releases erdafitinib, a small molecule FGFR inhibitor, directly into the bladder. It is being developed by Johnson & Johnson for non-muscle invasive bladder neoplasms and other urinary bladder neoplasms. It is a locally delivered oncology therapy rather than an oral or systemic treatment.
TAR-210 is being studied for non-muscle invasive bladder neoplasms and urinary bladder neoplasms, including high risk non-muscle invasive bladder cancer. The clinical program evaluates it against intravesical chemotherapy and single agent intravesical cancer treatment in biomarker-selected patients with bladder cancer.
TAR-210 delivers erdafitinib, which targets FGFR, a fibroblast growth factor receptor protein. By inhibiting FGFR signaling, the small molecule acts on tumors with FGFR alterations, and the delivery system releases it locally into the bladder. The program is biomarker selected, meaning patients are chosen based on FGFR status.
TAR-210 is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsors the Phase 3 and Phase 1 studies of the erdafitinib intravesical delivery system in bladder cancer across sites in the United States, Europe, Asia, Latin America, and other regions.
TAR-210 is in Phase 3 clinical development. Two Phase 3 studies are currently recruiting, and two Phase 1 studies are active but no longer recruiting. TAR-210 is investigational and has not been established as approved for any indication in the information available on this program.
TAR-210 is being studied in four registered trials. The Phase 3 studies are NCT06919965, comparing TAR-210 with intravesical chemotherapy in high risk non-muscle invasive bladder cancer, and NCT06319820, comparing it with single agent intravesical treatment. The Phase 1 studies are NCT05316155 and NCT05567185 in Japanese participants.
Yes, TAR-210 is also known as the erdafitinib intravesical delivery system. The name describes the product: a delivery system that administers erdafitinib, an FGFR-targeting small molecule, directly into the bladder. Searches for either name refer to the same Johnson & Johnson investigational bladder cancer asset.