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    DRUG:

    zalifrelimab (UGN-301)

    i
    Other names: UGN-301, AGEN-1884, AGEN1884, RebmAb-600, AGEN 1884, RebmAb600, UGN301, RebmAb 600, UGN 301
    Company:
    Agenus, Betta Pharma, Recepta, UroGen
    Drug class:
    CTLA4 antagonist
    Related drugs:
    7d
    RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer (clinicaltrials.gov)
    P2, N=212, Active, not recruiting, Agenus Inc. | Trial primary completion date: Aug 2024 --> Jan 2025
    Trial primary completion date • Combination therapy
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    14d
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=28, Recruiting, University of Colorado, Denver | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases
    |
    pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
    4ms
    rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG (clinicaltrials.gov)
    P1, N=36, Recruiting, Ann & Robert H Lurie Children's Hospital of Chicago | Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Checkpoint block
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    8ms
    A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P1, N=60, Recruiting, UroGen Pharma Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    gemcitabine • zalifrelimab (UGN-301) • Vesimune (imiquimod intravesical)
    9ms
    AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=4, Terminated, The University of Texas Health Science Center at San Antonio | Active, not recruiting --> Terminated; PI left the institution
    Trial termination • Combination therapy
    |
    cisplatin • gemcitabine • balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    9ms
    A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, Agenus Inc. | N=177 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy • Metastases
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    12ms
    NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=28, Active, not recruiting, Nelum Corp | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • zalifrelimab (UGN-301) • NLM-001
    12ms
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=28, Recruiting, University of Colorado, Denver | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases
    |
    doxorubicin hydrochloride • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
    over1year
    NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=28, Recruiting, Nelum Corp | Trial completion date: Jun 2023 --> Sep 2024 | Trial primary completion date: Jun 2023 --> Sep 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • zalifrelimab (UGN-301) • NLM-001
    over2years
    Balstilimab and other immunotherapy for recurrent and metastatic cervical cancer. (PubMed, Med Oncol)
    Recurrent and metastatic cervical cancer is generally treated by cisplatin, paclitaxel, and bevacizumab with limited benefit this constituting an unmet need...Recently, a PD-1 inhibitor, pembrolizumab was approved for such cancer...Balstilimab plus zalifrelimab combination (NCT03495882) produced improved clinical benefit over monotherapy as evidenced by higher relative response rates and longer response duration, as well as a manageable safety profile. Interesting development of this combination and other immunotherapies in R/M CC are discussed in this ensuing review.
    Review • Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • cisplatin • paclitaxel • Libtayo (cemiplimab-rwlc) • balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    almost3years
    Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study. (PubMed, J Clin Oncol)
    Promising and durable clinical activity, with favorable tolerability, was seen in this largest trial to date evaluating dual programmed death-1/cytotoxic T-lymphocyte-associated antigen-4 blockade in patients with recurrent and/or metastatic cervical cancer. Further investigation of the balstilimab and zalifrelimab combination in this setting is continuing.
    Clinical • P2 data • Journal • Checkpoint inhibition
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 negative
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    almost3years
    AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma (clinicaltrials.gov)
    P2, N=0, Withdrawn, Agenus Inc. | Trial completion date: Dec 2023 --> Sep 2021
    Clinical • Trial completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    over3years
    AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma (clinicaltrials.gov)
    P2, N=0, Withdrawn, Agenus Inc. | N=55 --> 0 | Recruiting --> Withdrawn
    Clinical • Enrollment change • Trial withdrawal • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    4years
    AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma (clinicaltrials.gov)
    P2, N=55, Recruiting, Agenus Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    4years
    AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma (clinicaltrials.gov)
    P2, N=55, Not yet recruiting, Agenus Inc.
    Clinical • New P2 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    over4years
    [VIRTUAL] Single-agent anti-PD-1 balstilimab or in combination with anti-CTLA-4 zalifrelimab for recurrent/metastatic (R/M) cervical cancer (CC): Preliminary results of two independent phase II trials (ESMO 2020)
    Funding: Agenus Inc. Clinical trial identification: NCT03104699, NCT03495882.
    P2 data • Late-breaking abstract • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)