Therapy Detail

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Therapy Name Enzalutamide + Pembrolizumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Enzalutamide Xtandi MDV3100|ASP9785 Hormone - Anti-androgens 27 Xtandi (enzalutamide) is a second-generation small molecule androgen receptor (AR) inhibitor that inhibits AR signaling, thereby resulting in decreased tumor growth (PMID: 24009414, PMID: 25945058). Xtandi (enzalutamide) is FDA approved for use in patients with castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer (FDA.gov).
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 63 Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, PD-L1 expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, and cervical cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, with axitinib in RCC, and with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR (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 Enzalutamide + Pembrolizumab Phase II Actionable In a Phase II trial, Keytruda (pembrolizumab) plus Xtandi (enzalutamide) treatment resulted in >=50% reduction in prostate-specific antigen (PSA) levels in 18% (5/28) of metastatic castrate-resistant prostate cancer patients, and led to an objective response rate of 25% (3/12, all partial response), a median PSA progression-free survival of 3.8 months, and a median overall survival of 22.2 mo. in all patients and 41.7 mo. in the three responders (PMID: 32616555; NCT02312557). 32616555

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Clinical Trial Phase Therapies Title Recruitment Status
NCT02312557 Phase II Enzalutamide + Pembrolizumab Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide Active, not recruiting
NCT04191096 Phase III Enzalutamide + Pembrolizumab Enzalutamide Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) Recruiting
NCT02861573 Phase I Dexamethasone + Docetaxel + Pembrolizumab + Prednisone Olaparib + Pembrolizumab Enzalutamide + Pembrolizumab Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365) Recruiting
NCT03834493 Phase III Enzalutamide + Pembrolizumab Enzalutamide Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) Recruiting
NCT03753243 Phase II Enzalutamide + Pembrolizumab Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer Recruiting
NCT04116775 Phase II Enzalutamide + Pembrolizumab Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer. Recruiting


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