^
    24d
    MoonRISe-3: A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=220, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Aug 2027 --> Apr 2028
    Trial primary completion date
    |
    gemcitabine • mitomycin • erdafitinib intravesical delivery system (TAR-210)
    2ms
    Erdafitinib in Patients with High- and Intermediate-risk Non-muscle-invasive Bladder Cancer: Final Analysis of THOR-2 Study. (PubMed, Eur Urol)
    Oral erdafitinib demonstrated high efficacy in FGFR3/2alt HR-/IR-NMIBC, with a manageable safety profile.
    Journal
    |
    FGFR3 (Fibroblast growth factor receptor 3)
    |
    Balversa (erdafitinib) • erdafitinib intravesical delivery system (TAR-210)
    3ms
    MoonRISe-3: A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=220, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • mitomycin • erdafitinib intravesical delivery system (TAR-210)
    5ms
    Novel intravesical delivery systems for nonmuscle invasive bladder cancer. (PubMed, Curr Opin Urol)
    Novel intravesical delivery systems show to enhance drug retention, improve tissue penetration, and potentially reduce adverse events. While traditional chemotherapy or BCG remain the gold-standard adjuvant treatments for NMIBC, these novel approaches offer promising alternatives for selected patients pending on ongoing clinical validation.
    Journal
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    paclitaxel • Inlexzo (gemcitabine intravesical system) • Oncofid-P (paclitaxel-hyaluronic acid conjugate) • Zusduri (mitomycin intravesicular) • erdafitinib intravesical delivery system (TAR-210)
    8ms
    MoonRISe-3: A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=220, Not yet recruiting, Janssen Research & Development, LLC
    New P3 trial
    |
    gemcitabine • mitomycin • erdafitinib intravesical delivery system (TAR-210)
    10ms
    Biological and therapeutic implications of FGFR alterations in urothelial cancer: A systematic review from non-muscle-invasive to metastatic disease. (PubMed, Actas Urol Esp (Engl Ed))
    Two phase 3 trials are currently evaluating the intravesical device system (TAR210) in FGFR-altered intermediate NMIBC (MoonRISe-1) and infigratinib in the adjuvant setting of high-risk of recurrence patients with MIBC or UTUC (PROOF-302)...Nine phase 1b/2 trials are focusing on the combination of FGFR inhibitors with ICIs, chemotherapy, or enfortumab vedotin...However, no phase 3 trial is terminated, so there is currently no level 1 evidence with long-term outcomes to support the combination of FGFR inhibitors with ICIs, chemotherapy, or targeted therapies. A better understanding of the different mechanisms of action to inhibit FGFR signaling pathways, optimal patient selection and treatment approaches is still needed.
    Journal • IO biomarker
    |
    FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR3 mutation
    |
    Truseltiq (infigratinib) • Padcev (enfortumab vedotin-ejfv) • erdafitinib intravesical delivery system (TAR-210)
    10ms
    Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov)
    P1/2, N=262, Recruiting, Janssen Research & Development, LLC | Phase classification: P1 --> P1/2
    Phase classification
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    10ms
    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 | Initiation date: Apr 2024 --> Jan 2024
    Trial initiation date
    |
    gemcitabine • erdafitinib intravesical delivery system (TAR-210)
    11ms
    CR109248: A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (clinicaltrials.gov)
    P1, N=5, Active, not recruiting, Janssen Pharmaceutical K.K. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    11ms
    Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov)
    P1, N=262, Recruiting, Janssen Research & Development, LLC | N=112 --> 262 | Trial completion date: Jun 2029 --> Sep 2029
    Enrollment change • Trial completion date
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    1year
    Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov)
    P1, N=112, Recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2028 --> Jun 2029
    Trial completion date
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR mutation • FGFR fusion
    |
    erdafitinib intravesical delivery system (TAR-210)
    over1year
    Urine-based molecular testing identifies FGFR alteration-positive patients for treatment with TAR-210 (ESMO 2024)
    P1, P3 | "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)