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  • ||||||||||  Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Vesimune (imiquimod intravesical) / UroGen
    Journal, PD(L)-1 Biomarker, IO biomarker:  Programmed Death Ligand 1 Modulation by Bacillus Calmette-Gu (Pubmed Central) -  Jul 1, 2025   
    Although the study did not meet the predefined endpoint for PFS improvement, promising signals of efficacy warrant future investigation including response/resistance biomarkers to inform patient selection. MTT (thiazolyl blue tetrazolium bromide) assays were conducted to determine non-cytotoxic concentrations of the immunomodulatory agents: 25
  • ||||||||||  Jelmyto (mitomycin urothelial gel) / UroGen
    Clinical, Journal:  Durability of response of UGN-101: Longitudinal follow up of multicenter study. (Pubmed Central) -  May 18, 2025   
    Further study is needed to better understand the long term outcomes of this novel therapy and also the risks/benefits of maintenance therapy in this setting. Caution should be used in patients with high-grade disease who appear to be at higher risk of relapse and death despite initial response.
  • ||||||||||  zalifrelimab (UGN-301) / Agenus, UroGen, botensilimab (AGEN1181) / Agenus, balstilimab (AGEN2034) / Agenus
    Enrollment change, Checkpoint inhibition:  Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov) -  May 3, 2025   
    P2,  N=65, Recruiting, 
    Caution should be used in patients with high-grade disease who appear to be at higher risk of relapse and death despite initial response. N=28 --> 65
  • ||||||||||  Jelmyto (mitomycin urothelial gel) / UroGen
    Journal:  Emerging strategies: conservative management of upper tract urothelial carcinoma. (Pubmed Central) -  Apr 27, 2025   
    The conservative management of UTUC is evolving, driven by advancements in imaging, molecular diagnostics, and minimally invasive treatments. While kidney-sparing approaches are increasingly utilized in low-risk patients, further prospective studies are needed to validate their efficacy.
  • ||||||||||  UGN-501 / UroGen
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Safety and Tolerability of Intravenous Administration of ICVB-1042 (clinicaltrials.gov) -  Apr 8, 2025   
    P1,  N=17, Terminated, 
    Evaluation of UGN-301 in combination with UGN-201 (Arm B) and gemcitabine (Arm C) is ongoing in the USA, Italy, and Spain. N=44 --> 17 | Trial completion date: Dec 2026 --> Dec 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2026 --> Dec 2024; Lack of Demonstrated Clinical Activity
  • ||||||||||  Jelmyto (mitomycin urothelial gel) / UroGen
    Journal:  The Role of Kidney-Sparing Surgery for Patients with Upper Tract Urothelial Carcinoma (Pubmed Central) -  Apr 7, 2025   
    trial assessing a mitomycin-containing reverse thermal gel (JelmytoTM)revealed the promising result despite their use not being approved in Japan. Therefore, KSS is assumed to have an increasing demand for patients with UTUC in our aged society and is expected to be widely utilized nationwide.
  • ||||||||||  Review, Journal:  New Treatment Options for Non-Muscle-Invasive Bladder Cancer. (Pubmed Central) -  Feb 11, 2025   
    Additionally, immune checkpoint inhibitors such as pembrolizumab and durvalumab have demonstrated potential for systemic treatments in BCG-unresponsive NMIBC and may show even more promise in combinations...For low-grade NMIBC, efforts are underway to de-escalate care through active surveillance and novel adjuvant therapies, reducing the need for repeated TURBT procedures. Together, these advancements highlight a promising shift toward personalized, bladder-preserving strategies that prioritize patient quality of life while addressing unmet needs in NMIBC management.
  • ||||||||||  zalifrelimab (UGN-301) / Agenus, UroGen, botensilimab (AGEN1181) / Agenus, balstilimab (AGEN2034) / Agenus
    Trial completion date, Trial primary completion date, Checkpoint inhibition:  Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov) -  Dec 5, 2024   
    P2,  N=28, Recruiting, 
    Trial primary completion date: Aug 2024 --> Jan 2025 Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
  • ||||||||||  Jelmyto (mitomycin urothelial gel) / UroGen
    Trial completion date, Trial primary completion date:  Phase II Trial of Lung Chemoemobolization (clinicaltrials.gov) -  Nov 29, 2024   
    P2,  N=30, Recruiting, 
    Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025 Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2026
  • ||||||||||  Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
    Journal:  The DNA sensor AIM2 mediates psoriasiform inflammation by inducing type 3 immunity. (Pubmed Central) -  Nov 13, 2024   
    We found elevated levels of mitochondrial DNA in patients with psoriasis, along with high expression of AIM2 in both the human psoriatic epidermis and a mouse model of psoriasis induced by topical imiquimod (IMQ) application...Finally, the genetic absence of inflammasome components downstream AIM2, ASC, and caspase-1 alleviated IMQ-induced skin inflammation. Collectively, our data show that AIM2 is involved in developing psoriasis through its canonical activation.
  • ||||||||||  zalifrelimab (UGN-301) / Agenus, UroGen, balstilimab (AGEN2034) / Agenus
    Trial completion date, Trial primary completion date, Combination therapy, Checkpoint inhibition, Checkpoint block:  rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG (clinicaltrials.gov) -  Aug 21, 2024   
    P1,  N=36, Recruiting, 
    Conclusions Bal monotherapy and bal plus zal showed promising clinical efficacy and manageable safety profile in PD-L1 positive, recurrent or metastatic cervical cancer. Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025