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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:
    15d
    A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Memorial Sloan Kettering Cancer Center | N=37 --> 0 | Active, not recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy
    |
    Aliqopa (copanlisib) • Firmagon (degarelix)
    1m
    A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer (clinicaltrials.gov)
    P1/2, N=37, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Aliqopa (copanlisib) • Firmagon (degarelix)
    1m
    Androgen Deprivation Therapy Prior to Prostatectomy for Patients with Intermediate and High Risk Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=41, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Sep 2024 | Trial primary completion date: Feb 2025 --> Sep 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    CASP3 (Caspase 3)
    |
    Firmagon (degarelix)
    1m
    Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    VIM (Vimentin) • CDH2 (Cadherin 2)
    |
    VIM expression
    |
    Mekinist (trametinib) • dasatinib • Xtandi (enzalutamide capsule) • Firmagon (degarelix)
    2ms
    FIRMAGON® Intensive Drug Monitoring (clinicaltrials.gov)
    P=N/A, N=1454, Completed, Ferring Pharmaceuticals | N=2193 --> 1454
    Enrollment change
    |
    Firmagon (degarelix)
    2ms
    Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer. (clinicaltrials.gov)
    P2, N=52, Active, not recruiting, Medical University of South Carolina | Trial completion date: Sep 2024 --> Dec 2024
    Trial completion date • Metastases
    |
    docetaxel • Firmagon (degarelix)
    2ms
    Androgen Deprivation Therapy Drives a Distinct Immune Phenotype in Localized Prostate Cancer. (PubMed, Clin Cancer Res)
    These observations underscore the critical role of timing and disease context in order to optimize the therapeutic efficacy of immune modulators combined with androgen ablation, for which the presurgical neoadjuvant setting may be ideal. Our findings warrant future prospective validation, which is currently underway.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Firmagon (degarelix)
    3ms
    Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer (clinicaltrials.gov)
    P3, N=56, Terminated, Memorial Sloan Kettering Cancer Center | Completed --> Terminated; Due to low accrual
    Trial termination
    |
    Firmagon (degarelix)
    3ms
    Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)
    P1/2, N=9, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | N=93 --> 9
    Enrollment change
    |
    Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)
    3ms
    PRESTO: A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer (clinicaltrials.gov)
    P3, N=504, Active, not recruiting, Alliance Foundation Trials, LLC. | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    abiraterone acetate • prednisone • bicalutamide • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension
    4ms
    Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (clinicaltrials.gov)
    P2, N=32, Not yet recruiting, OHSU Knight Cancer Institute
    New P2 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    4ms
    Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)
    P1/2, N=93, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial primary completion date
    |
    Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)
    4ms
    First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Jul 2028 | Trial primary completion date: Jan 2027 --> Jul 2027
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • Tevimbra (tislelizumab-jsgr) • Xtandi (enzalutamide capsule) • abiraterone acetate • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    4ms
    Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov)
    P2; Trial primary completion date: Jun 2024 --> Dec 2024
    Combination therapy • Trial primary completion date • Metastases
    |
    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)
    |
    OncoPanel™ Assay
    |
    Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    4ms
    NRG-GU002: Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery (clinicaltrials.gov)
    P2/3, N=612, Active, not recruiting, NRG Oncology | N=175 --> 612 | Trial completion date: May 2031 --> May 2026
    Enrollment change • Trial completion date • Surgery
    |
    docetaxel • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • flutamide • nilutamide • Firmagon (degarelix) • Viadur (leuprorelin implant)
    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, Active, not recruiting, Columbia University | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial primary completion date
    |
    Firmagon (degarelix) • BMS-986218
    4ms
    ARNEO: Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Universitaire Ziekenhuizen KU Leuven | Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Jul 2024
    Enrollment closed • Trial completion date
    |
    Erleada (apalutamide) • Firmagon (degarelix)
    5ms
    LILAC: Cardiometabolic Consequences of the Loss of Ovarian Function (clinicaltrials.gov)
    P4, N=100, Recruiting, University of Colorado, Denver | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Firmagon (degarelix)
    5ms
    Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (clinicaltrials.gov)
    P2, N=120, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    6ms
    Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, University of Colorado, Denver | Trial completion date: Apr 2024 --> Apr 2025
    Trial completion date
    |
    Xtandi (enzalutamide capsule) • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    7ms
    ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer (clinicaltrials.gov)
    P3, N=392, Recruiting, NYU Langone Health
    New P3 trial
    |
    Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    7ms
    Myeloid-derived suppressor cells attenuate the antitumor efficacy of radiopharmaceutical therapy using 90Y-NM600 in combination with androgen deprivation therapy in murine prostate tumors. (PubMed, J Immunother Cancer)
    The combination of ADT and TRT improved antitumor responses in murine models of prostate cancer, however, this was dependent on the order of administration. This was found to be associated with one treatment sequence leading to an increase in infiltrating MDSCs. Combining treatment with a CXCR2 antagonist improved the antitumor effect of this combination, suggesting a possible approach for treating advanced human prostate cancer.
    Preclinical • Journal • Combination therapy
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CXCR2 (Chemokine (C-X-C motif) receptor 2) • CXCL1 (Chemokine (C-X-C motif) ligand 1)
    |
    Firmagon (degarelix) • 90Y-NM600 • reparixin (DF 1681Y)
    7ms
    NeoADT-TULSA: Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer (clinicaltrials.gov)
    P1, N=15, Recruiting, Turku University Hospital | Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Oct 2023 | Trial primary completion date: Jul 2025 --> Dec 2025
    Enrollment open • Trial initiation date • Trial primary completion date
    |
    Firmagon (degarelix)
    7ms
    Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting
    Combination therapy • Enrollment closed • Metastases
    |
    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
    7ms
    Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov)
    P=N/A, N=1, Completed, Pfizer | Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • HEOR • Real-world evidence • Real-world • Metastases
    |
    docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • cabazitaxel • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Xofigo (radium Ra-223 dichloride) • leuprolide acetate for depot suspension
    7ms
    Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Mayo Clinic
    New P2 trial • Metastases
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    7ms
    EORTC-1532: ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer (clinicaltrials.gov)
    P2, N=61, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: May 2024 --> Dec 2036
    Trial completion date
    |
    Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix)
    7ms
    PEGASUS: Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer (clinicaltrials.gov)
    P3, N=885, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Nov 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    Firmagon (degarelix)
    8ms
    NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial (clinicaltrials.gov)
    P1/2, N=36, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Firmagon (degarelix)
    8ms
    HyBraFi: Toxicity Comparison Between Hypofractionated Radiotherapy With HDR Brachytherapy Boost Versus Standard Treatment (clinicaltrials.gov)
    P=N/A, N=30, Active, not recruiting, CHU de Quebec-Universite Laval | Trial completion date: Jun 2023 --> Jun 2025 | Trial primary completion date: Mar 2023 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    Firmagon (degarelix)
    8ms
    Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study) (clinicaltrials.gov)
    P4, N=55, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Firmagon (degarelix)
    9ms
    Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, M.D. Anderson Cancer Center | Initiation date: Sep 2023 --> Sep 2024
    Trial initiation date • Combination therapy • Metastases
    |
    Talzenna (talazoparib) • Xtandi (enzalutamide capsule) • Firmagon (degarelix)
    9ms
    Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=41, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date
    |
    CASP3 (Caspase 3)
    |
    Firmagon (degarelix)
    9ms
    Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)
    P1/2, N=93, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)
    9ms
    THUNDER: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (clinicaltrials.gov)
    P2/3; N=493; Recruiting; Sponsor:Cancer Research Antwerp
    New P2/3 trial
    |
    Decipher Prostate Cancer Test
    |
    docetaxel • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix)
    9ms
    LILAC: Cardiometabolic Consequences of the Loss of Ovarian Function (clinicaltrials.gov)
    P4, N=100, Not yet recruiting, University of Colorado, Denver
    New P4 trial
    |
    Firmagon (degarelix)
    9ms
    SAVE: Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP (clinicaltrials.gov)
    P2, N=202, Recruiting, Cancer Research Antwerp | Trial completion date: Sep 2022 --> Dec 2025 | Trial primary completion date: Dec 2021 --> Aug 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    9ms
    First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=31, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Phase classification: P2a --> P2 | Trial completion date: May 2026 --> Jan 2027 | Trial primary completion date: May 2025 --> Jan 2027
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • Tevimbra (tislelizumab-jsgr) • Xtandi (enzalutamide capsule) • abiraterone acetate • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    9ms
    Addressing the risk and management of cardiometabolic complications in prostate cancer patients on androgen deprivation therapy and androgen receptor axis-targeted therapy: consensus statements from the Hong Kong Urological Association and the Hong Kong Society of Uro-Oncology. (PubMed, Front Oncol)
    The panel reached a consensus on 18 statements based on recent evidence and expert insights. These consensus statements serve as a practical recommendation for clinicians in Hong Kong, and possibly the Asia-Pacific region, in the management of cardiometabolic toxicities of ADT or AR axis-targeted therapies in men with PCa.
    Review • Journal
    |
    AR (Androgen receptor)
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension
    10ms
    Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study) (clinicaltrials.gov)
    P=N/A, N=300, Active, not recruiting, Chinese University of Hong Kong | Recruiting --> Active, not recruiting | N=600 --> 300
    Enrollment closed • Enrollment change
    |
    Eligard (leuprolide acetate) • Firmagon (degarelix)
    10ms
    A Study of Copanlisib in Combination With Degarelix in People With Prostate Cancer (clinicaltrials.gov)
    P1/2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1/2 trial • Combination therapy
    |
    Aliqopa (copanlisib) • Firmagon (degarelix)
    10ms
    Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer. (clinicaltrials.gov)
    P2, N=52, Active, not recruiting, Medical University of South Carolina | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • Firmagon (degarelix)