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    DRUG:

    Inlexzo (gemcitabine intravesical system)

    i
    Other names: TAR-200, TAR 200, JNJ-17000139, JNJ-17000139-AAC, TAR200, JNJ17000139, JNJ 17000139
    Company:
    J&J
    Drug class:
    DNA synthesis inhibitor
    Related drugs:
    1m
    Can manual gemcitabine instillation or tumor microenvironment-based selection enhance the efficacy of TAR-200 in bladder cancer? (PubMed, Transl Oncol)
    We hypothesize that assessing baseline or BCG-induced immunosuppressive status may help identify patients who would derive greater benefit from the addition of the PD-1 inhibitor cetrelimab to TAR-200. These considerations warrant further investigation to maximize therapeutic efficacy in this challenging patient population.
    Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    2ms
    SunRISe-4: A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder (clinicaltrials.gov)
    P2, N=163, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed
    Trial completion
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    4ms
    17000139BLC2002: A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy (2023-507189-17-00)
    P1/2, N=89, Completed, Janssen - Cilag International | Active, not recruiting --> Completed
    Trial completion
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    4ms
    Nova-sTAR: A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States (clinicaltrials.gov)
    P=N/A, N=150, Recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2029 --> Oct 2029
    Trial completion date • Real-world evidence
    |
    Inlexzo (gemcitabine intravesical system)
    5ms
    SunRISe-4: A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder (clinicaltrials.gov)
    P2, N=163, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2027 --> Mar 2026
    Trial completion date
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    5ms
    Advances in Intravesical Therapy for Non-Muscle-Invasive Bladder Cancer. (PubMed, Crit Rev Oncol Hematol)
    Intermediate-risk patients could benefit from either intravesical chemotherapy or Bacillus Calmette-Guérin (BCG) instillation, with emerging therapies such as UGN-102 chemoablation showing promise...Moreover, alternative agents such as sequential gemcitabine and docetaxel instillation have demonstrated favorable outcomes in both BCG-naïve and BCG-unresponsive patients...Gene therapy (nadofaragene firadenovec), oncolytic viral therapy (CG0070), interleukin-15 superagonist (Nogapendekin alfa-inbakicept), and innovative drug delivery systems (TAR-200) have shown encouraging clinical potential in this population. This review provides an overview of current intravesical treatment strategies for NMIBC across different risk groups and highlights promising new approaches aimed at overcoming the limitations of BCG therapy.
    Review • Journal
    |
    IL15 (Interleukin 15)
    |
    docetaxel • Adstiladrin (nadofaragene firadenovec-vncg) • Anktiva (nogapendekin alfa inbakicept-pmln) • cretostimogene grenadenorepvec (CG0070) • Inlexzo (gemcitabine intravesical system) • Zusduri (mitomycin intravesicular)
    5ms
    Nova-sTAR: A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States (clinicaltrials.gov)
    P=N/A, N=150, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open • Real-world evidence
    |
    Inlexzo (gemcitabine intravesical system)
    7ms
    Nova-sTAR: A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States (clinicaltrials.gov)
    P=N/A, N=150, Not yet recruiting, Janssen Research & Development, LLC
    New trial • Real-world evidence
    |
    Inlexzo (gemcitabine intravesical system)
    8ms
    SunRISe-1: A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (clinicaltrials.gov)
    P2, N=220, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jul 2027 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    10ms
    SunRISe-5: A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) (clinicaltrials.gov)
    P3, N=272, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    mitomycin • Inlexzo (gemcitabine intravesical system)
    1year
    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) • erdafitinib intravesical delivery system (TAR-210) • Oncofid-P (paclitaxel-hyaluronic acid conjugate) • Zusduri (mitomycin intravesicular)
    1year
    SunRISe-2: A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder (clinicaltrials.gov)
    P3, N=518, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2029 --> Dec 2028
    Trial completion date
    |
    cisplatin • cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)