Therapy Detail

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Therapy Name Apalutamide
Synonyms
Therapy Description

Erleada (apalutamide) is a second-generation antiandgrogen, that binds to the androgen receptor (AR) and inhibits downstream signaling, potentially resulting in decreased growth of AR-expressing tumors (PMID: 22266222, PMID: 23337756). Erleada (apalutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Apalutamide Erleada ARN-509|JNJ-56021927 Hormone - Anti-androgens 27 Erleada (apalutamide) is a second-generation antiandgrogen, that binds to the androgen receptor (AR) and inhibits downstream signaling, potentially resulting in decreased growth of AR-expressing tumors (PMID: 22266222, PMID: 23337756). Erleada (apalutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown prostate cancer not applicable Apalutamide FDA approved Actionable In a Phase III trial that supported FDA approval, treatment with Erleada (apalutamide) resulted in a median metastasis-free survival of 40.5 months in patients with non-metastatic castration-resistant prostate cancer, compared to 16.2 months with placebo (HR=0.28) (PMID: 29420164; NCT01946204). detail... 29420164
Unknown unknown prostate cancer not applicable Apalutamide FDA approved Actionable In a Phase III trial (TITAN) that supported FDA approval, treatment with Erleada (apalutamide) plus androgen-deprivation therapy (ADT) resulted in a radiographic progression-free survival at 24 months in 68.2% (358/525) of patients with metastatic castration-sensitive prostate cancer, compared to 47.5% (250/527) in patients treated with ADT and placebo (HR=0.48, p<0.001), and improved overall survival at 24 months (82.4% vs 73.5%, HR=0.89, p=0.005) (PMID: 31150574; NCT02489318). 31150574 detail...
Unknown unknown prostate cancer not applicable Apalutamide Clinical Study Actionable In a clinical study, Erleada (apalutamide) demonstrated safety and efficacy, resulted in 12-week PSA response rate of 88% (22/25) and 22% (4/18), median time to PSA progression of 18.2 months and 3.7 months, in castration-resistant prostate cancer patients that were treatment-naive or those received prior abiraterone and prednisone (PMID: 28213364). 28213364

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03279250 Phase II Goserelin Triptorelin Abiraterone + Apalutamide + Prednisone Leuprolide Apalutamide Effects of Apalutamide Plus LHRH Agonist or Apalutamide Plus Abiraterone Acetate Plus LHRH Agonist for Six Months for Prostate Cancer Patients at High Risk for Recurrence Active, not recruiting
NCT01946204 Phase III Apalutamide A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN) Active, not recruiting
NCT01790126 Phase II Apalutamide The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer Completed
NCT03371719 Phase II Apalutamide Radiation Therapy With or Without Apalutamide in Treating Patients With Stage III-IV Prostate Cancer Active, not recruiting
NCT02949284 Phase II Apalutamide Abiraterone + Apalutamide + Prednisone Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery Recruiting
NCT02489318 Phase III Apalutamide A Phase 3 Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With Low-Volume mHSPC Active, not recruiting
NCT03767244 Phase III Apalutamide Abiraterone + Apalutamide Prednisone A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy Recruiting
NCT02721979 Phase II Apalutamide ARN-509 in Treating Patients With Prostate Cancer Who Are in Active Surveillance Active, not recruiting
NCT02578797 Phase I Apalutamide A JNJ-56021927 (ARN-509) QT/QTc Study Active, not recruiting
NCT02906605 Phase II Apalutamide Apalutamide + JNJ-64041809 A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer Withdrawn
NCT03412396 Phase II Apalutamide Single Arm Study of 6-Months Neoadjuvant ARN-509 Prior to Radical Prostatectomy Active, not recruiting
NCT03503344 Phase II Apalutamide Apalutamide With or Without Stereotactic Body Radiation Therapy in Treating Participants With Castration-Resistant Prostate Cancer (PILLAR) Recruiting


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