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    DRUG:

    Firmagon (degarelix)

    i
    Other names: FE200486, ASP-3550, ASP3550, uglypeptide-1, FE-200486
    Company:
    Astellas, Ferring
    Drug class:
    GnRH antagonist
    Related drugs:
    3d
    Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Nov 2028 | Trial primary completion date: Jan 2027 --> Nov 2028
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    docetaxel • Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    11d
    PRESTO: A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer (clinicaltrials.gov)
    P3, N=504, Completed, Alliance Foundation Trials, LLC. | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Jun 2025
    Trial completion • Trial completion date
    |
    abiraterone acetate • prednisone • bicalutamide • apalutamide • Firmagon (degarelix) • leuprolide acetate for depot suspension
    15d
    Characteristics of tertiary lymphoid structures in prostate cancer and the impact of neoadjuvant therapy on their formation and maturation. (PubMed, Front Immunol)
    Flow cytometry evaluated immune infiltration in bicalutamide-treated mice, and anti-PD1 was combined with degarelix/bicalutamide in preclinical mouse model. NHT enhances TLS formation, maturation, and immune cell infiltration, suggesting a synergistic role for androgen deprivation in shaping the tumor immune microenvironment. The improved anti-tumor response with combined anti-PD1 and ADT highlights the potential of immunotherapy-endocrine therapy combinations as a promising treatment strategy for PCa.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • FOXP3 (Forkhead Box P3)
    |
    bicalutamide • Firmagon (degarelix)
    26d
    Neoadjuvant Antiandrogen Therapy With or Without MEK or SRC Inhibition for Unfavorable-risk Prostate Cancer: A Phase 2 Randomized Clinical Trial. (PubMed, Eur Urol Oncol)
    Neoadjuvant SRC or MEK inhibition does not appear to mitigate the EMT response to ADT or influence clinical or pathological outcomes.
    Clinical • P2 data • Journal
    |
    MAP2K1 (Mitogen-activated protein kinase kinase 1) • MAP2K2 (Mitogen-activated protein kinase kinase 2) • VIM (Vimentin) • CDH2 (Cadherin 2)
    |
    Mekinist (trametinib) • dasatinib • Xtandi (enzalutamide) • Firmagon (degarelix)
    2ms
    RTOG 0815: Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer (clinicaltrials.gov)
    P3, N=1538, Completed, Radiation Therapy Oncology Group | Active, not recruiting --> Completed
    Trial completion
    |
    bicalutamide • triptorelin • goserelin acetate • flutamide • Firmagon (degarelix) • leuprolide acetate for depot suspension • Suprefact (buserelin acetate)
    2ms
    Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, OHSU Knight Cancer Institute | N=32 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    3ms
    The COSMYC Trial (COmbined Suppression of MYC) (clinicaltrials.gov)
    P2, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Xtandi (enzalutamide) • Eligard (leuprolide acetate) • triptorelin • goserelin acetate • ZEN-3694 • Firmagon (degarelix) • Orgovyx (relugolix)
    3ms
    Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial (clinicaltrials.gov)
    P3, N=2753, Active, not recruiting, NRG Oncology | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD4 (CD4 Molecule)
    |
    bicalutamide • apalutamide • triptorelin • goserelin acetate • flutamide • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension • Suprefact (buserelin acetate)
    3ms
    Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P2 trial
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix)
    4ms
    Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer or Ipilimumab and Degarelix in Men With Biochemically Recurrent Castration Sensitive Prostate Cancer After Radical Prostatectomy (clinicaltrials.gov)
    P2, N=16, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Yervoy (ipilimumab) • Firmagon (degarelix)
    4ms
    Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Xiao X. Wei, MD | Trial primary completion date: Oct 2024 --> Jul 2025
    Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    OncoPanel™ Assay
    |
    Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    4ms
    Neo-Red-P: Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer (clinicaltrials.gov)
    P1, N=26, Completed, Columbia University | Active, not recruiting --> Completed
    Trial completion
    |
    Firmagon (degarelix) • BMS-986218