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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
12d
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Xiao X. Wei, MD | Trial completion date: Dec 2025 --> Jun 2026
Trial completion date
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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)
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PD-L1 expression • MSI-H/dMMR
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OncoPanel™ Assay
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Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
20d
APEX: Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Jan 2026 --> Jan 2027
Trial primary completion date
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Xtandi (enzalutamide) • Eligard (leuprolide acetate) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix)
21d
New P2 trial
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Firmagon (degarelix)
27d
Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov)
P2, N=82, 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
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CD34 (CD34 molecule)
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Chr t(15;17)
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cyclophosphamide • Firmagon (degarelix) • thiotepa • leuprolide acetate for depot suspension • Kepivance (palifermin)
1m
New P2 trial
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goserelin acetate • Firmagon (degarelix)
1m
Enrollment change
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Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • apalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
2ms
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, Completed, NRG Oncology | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Oct 2025 | Trial primary completion date: May 2026 --> Oct 2025
Trial completion • Trial completion date • Trial primary completion date
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docetaxel • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • flutamide • nilutamide • Firmagon (degarelix) • Viadur (leuprorelin implant)
2ms
New P2 trial
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docetaxel • abiraterone acetate • triptorelin • goserelin acetate • Firmagon (degarelix)
2ms
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
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docetaxel • Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
2ms
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
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abiraterone acetate • prednisone • bicalutamide • apalutamide • Firmagon (degarelix) • leuprolide acetate for depot suspension
3ms
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
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CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • FOXP3 (Forkhead Box P3)
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bicalutamide • Firmagon (degarelix)
3ms
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
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MAP2K1 (Mitogen-activated protein kinase kinase 1) • MAP2K2 (Mitogen-activated protein kinase kinase 2) • VIM (Vimentin) • CDH2 (Cadherin 2)
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Mekinist (trametinib) • dasatinib • Xtandi (enzalutamide) • Firmagon (degarelix)