^
    4ms
    Urine-based molecular testing identifies FGFR alteration-positive patients for treatment with TAR-210 (ESMO 2024)
    Urine testing identifies additional NMIBC pts who may respond to erdafitinib, which is especially valuable when the parallel tissue sample submitted does not return a result. Findings support urine testing for pt selection in the recently initiated phase 3 study (MoonRISe-1, NCT06319820).
    Clinical
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    therascreen® FGFR RGQ RT-PCR Kit • PredicineCARE™
    |
    erdafitinib intravesical delivery system (TAR-210)
    7ms
    MoonRISe-1: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (clinicaltrials.gov)
    P3, N=540, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • erdafitinib intravesical delivery system (TAR-210)
    8ms
    Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov)
    P1, N=112, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2027 --> Mar 2028 | Trial primary completion date: Apr 2025 --> Mar 2028
    Trial completion date • Trial primary completion date
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    8ms
    MoonRISe-1: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (clinicaltrials.gov)
    P3, N=540, Not yet recruiting, Janssen Research & Development, LLC
    New P3 trial
    |
    gemcitabine • erdafitinib intravesical delivery system (TAR-210)
    11ms
    Urine-based testing for patient selection and genomic characterization of patients with FGFR alteration-positive non–muscle-invasive bladder cancer (NMIBC) treated with TAR-210. (ASCO-GU 2024)
    Implementing a urine-based assay expands the molecular testing methods to identify additional patients that may respond to erdafitinib. Results justify further study. Clinical trial information: NCT05316155.
    Clinical
    |
    FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR3 S249C
    |
    therascreen® FGFR RGQ RT-PCR Kit • PredicineCARE™
    |
    erdafitinib intravesical delivery system (TAR-210)
    12ms
    TAR-210: A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (clinicaltrials.gov)
    P1, N=6, Recruiting, Janssen Pharmaceutical K.K. | Trial completion date: Oct 2026 --> Jul 2027
    Trial completion date
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    1year
    Erdafitinib in BCG-treated high-risk non-muscle invasive bladder cancer. (PubMed, Ann Oncol)
    Erdafitinib prolonged RFS compared with intravesical chemotherapy in patients with papillary-only, high-risk NMIBC harboring FGFR alterations who had disease recurrence after BCG therapy and refused or were ineligible for radical cystectomy. (Funded by Janssen Research & Development; ClinicalTrials.gov number, NCT04172675).
    Journal
    |
    FGFR3 (Fibroblast growth factor receptor 3)
    |
    gemcitabine • Balversa (erdafitinib) • mitomycin • erdafitinib intravesical delivery system (TAR-210)
    over1year
    First safety and efficacy results of the TAR-210 erdafitinib (erda) intravesical delivery system in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations (alt) (ESMO 2023)
    Conclusions TAR-210 appears safe and well tolerated with predominantly low-grade urinary system AEs and high CR rate and RF survival in pts with NMIBC with FGFRalt. Results justify further study of targeted tx of erda using a novel intravesical delivery system in early-stage bladder cancer.
    Clinical • Late-breaking abstract
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    erdafitinib intravesical delivery system (TAR-210)
    over1year
    TAR-210: A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (clinicaltrials.gov)
    P1, N=6, Recruiting, Janssen Pharmaceutical K.K. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    almost2years
    TAR-210: A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Janssen Pharmaceutical K.K. | Initiation date: Dec 2022 --> Mar 2023
    Trial initiation date
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    almost2years
    Safety and efficacy of the erdafitinib (erda) intravesical delivery system, TAR-210, in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC) harboring select FGFR mutations or fusions: Phase 1 first-in-human study. (ASCO-GU 2023)
    Four cohorts will be enrolled: pts with recurrent, bacillus Calmette-Guerin (BCG)-experienced papillary-only high-risk (HR) NMIBC (high-grade Ta/T1) refusing or ineligible for radical cystectomy (RC) (Cohort 1) or scheduled for RC (Cohort 2); pts with recurrent, intermediate-risk NMIBC (Ta/T1) with a history of low-grade disease (Cohort 3); pts with cT2-T3a MIBC scheduled for RC refusing or ineligible for neoadjuvant cisplatin (Cohort 4). Four pts were enrolled since April 2022 (1 in Cohort 1, 3 in Cohort 3); enrollment for Cohorts 2 and 4 is planned soon. Clinical trial information: NCT05316155.
    Clinical • P1 data
    |
    FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    cisplatin • erdafitinib intravesical delivery system (TAR-210)
    2years
    TAR-210: A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Janssen Pharmaceutical K.K.
    New P1 trial
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    over2years
    Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov)
    P1, N=92, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    over2years
    Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov)
    P1, N=92, Not yet recruiting, Janssen Research & Development, LLC
    New P1 trial
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)