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    DRUG:

    Adstiladrin (nadofaragene firadenovec-vncg)

    i
    Other names: rAd-IFN/Syn3, SCH 721015/SCH 209702, Ad-IFNalpha/Syn3, rAd-IFN, TR002, FE 999326
    Company:
    FKD Therapies, Ferring, Royalty
    Drug class:
    IFNα stimulant
    Related drugs:
    2d
    TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=52, Recruiting, University of California, Davis | Not yet recruiting --> Recruiting | Trial completion date: Dec 2030 --> Feb 2030
    Enrollment open • Trial completion date
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    8d
    Gene Therapy for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Current Evidence and Future Directions. (PubMed, Cancers (Basel))
    Nadofaragene firadenovec, a recombinant adenovirus delivering interferon alpha-2b (IFNα2b), is the first FDA-approved gene therapy for BCG-unresponsive NMIBC with carcinoma in situ (CIS)...Cretostimogene grenadenorepvec (CG0070), an oncolytic vector, demonstrated a 47% 6-month CR rate in a phase II study (NCT02365818). Detalimogene voraplasmid (EG-70), a nonviral gene therapy, demonstrated a 47% 6-month CR in a phase I/II study (NCT04752722). Future advances are likely to focus on patient selection, novel vectors, and combination strategies to improve treatment outcomes. Gene therapy represents a significant addition to the bladder cancer treatment landscape by offering bladder-sparing alternatives where conventional therapies are limited.
    Review • Journal
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    IFNA1 (Interferon Alpha 1)
    |
    Adstiladrin (nadofaragene firadenovec-vncg) • cretostimogene grenadenorepvec (CG0070) • detalimogene voraplasmid (EG-70)
    2ms
    ABLE-32: Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=454, Recruiting, Ferring Pharmaceuticals | Trial completion date: Mar 2030 --> Jun 2031 | Trial primary completion date: Mar 2030 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    2ms
    TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=52, Not yet recruiting, University of California, Davis
    New P1 trial
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    3ms
    Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P3, N=25, Active, not recruiting, Ferring Pharmaceuticals | Trial primary completion date: Oct 2025 --> Nov 2029
    Trial primary completion date
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    3ms
    ABLE-41: ADSTILADRIN Early Utilization and Outcomes in the Real World Setting (clinicaltrials.gov)
    P=N/A, N=400, Recruiting, Ferring Pharmaceuticals | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date • Real-world evidence
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    5ms
    Emerging bladder-sparing treatments for high risk non-muscle invasive bladder cancer. (PubMed, Bladder Cancer)
    Emerging BSTs include immune checkpoint inhibitors like pembrolizumab and novel agents such as nadofaragene firadenovec and nogapendekin alfa inbakicept (IL-15)...Gene therapies and targeted agents like CG0070 and EG-70 are also gaining traction for their innovative mechanisms...Despite advancements, challenges remain in balancing efficacy, safety, and cost-effectiveness within diverse healthcare settings. This narrative review highlights the evolving landscape of BSTs for HR-NMIBC, emphasising the need for robust clinical evidence to refine patient selection and optimise outcomes.
    Review • Journal
    |
    IL15 (Interleukin 15)
    |
    Keytruda (pembrolizumab) • Adstiladrin (nadofaragene firadenovec-vncg) • Anktiva (nogapendekin alfa inbakicept-pmln) • cretostimogene grenadenorepvec (CG0070)
    5ms
    ABLE-22: A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=250, Recruiting, Ferring Pharmaceuticals | Trial primary completion date: Dec 2030 --> Jun 2028
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • gemcitabine • docetaxel • Adstiladrin (nadofaragene firadenovec-vncg)
    6ms
    LUNAR: Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis (clinicaltrials.gov)
    P1/2, N=20, Recruiting, Ferring Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    6ms
    ABLE-22: A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=250, Recruiting, Ferring Pharmaceuticals | Phase classification: P2 --> P3 | N=150 --> 250
    Phase classification • Enrollment change
    |
    Keytruda (pembrolizumab) • gemcitabine • docetaxel • Adstiladrin (nadofaragene firadenovec-vncg)
    7ms
    ABLE-32: Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=454, Recruiting, Ferring Pharmaceuticals | Trial completion date: Jun 2031 --> Mar 2030 | Trial primary completion date: Aug 2028 --> Mar 2030
    Trial completion date • Trial primary completion date
    |
    Adstiladrin (nadofaragene firadenovec-vncg)
    7ms
    ABLE-22: A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=150, Recruiting, Ferring Pharmaceuticals | Trial completion date: Jul 2028 --> Dec 2030 | Trial primary completion date: Jul 2026 --> Dec 2030
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • gemcitabine • docetaxel • Adstiladrin (nadofaragene firadenovec-vncg)