Therapy Detail
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| Therapy Name | Niraparib + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Niraparib | Zejula | MK4827 | PARP Inhibitor (Pan) 23 | Zejula (niraparib) binds and inhibits PARP, which may result in accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved as maintenance therapy in patients with recurrent or newly-diagnosed epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy, and in ovarian, fallopian tube, or primary peritoneal cancer that received 3 or more chemotherapies and is homologous recombination deficient as indicated by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and progressed 6 months or more after response to last platinum-based chemotherapy (FDA.gov). |
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 135 PD-L1/PD-1 antibody 80 | 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, CD274 (PD-L1)-expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, cervical cancer, and triple-negative breast 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 or lenvatinib in RCC, with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemotherapy for patients with esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma, and in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CD274 over exp | lung non-small cell carcinoma | predicted - sensitive | Niraparib + Pembrolizumab | Phase II | Actionable | In a Phase II trial, combination Zejula (niraparib) and Keytruda (pembrolizumab) resulted in an objective response rate (ORR) of 56.3% (9/16; 2 complete, 7 partial responses), 19.7-mo median duration of response (mDR), and 8.4-mo median progression-free survival (mPFS) in non-small cell lung cancer patients with a CD274 (PD-L1) TPS>=50%, and an ORR of 20% (4/20; 4 partial responses), 9.4-mo mDR, and 4.2-mo mPFS in patients with a CD274 (PD-L1) TPS=1-49% (PMID: 34478166; NCT03308942). | 34478166 |
| CD274 positive | lung non-small cell carcinoma | predicted - sensitive | Niraparib + Pembrolizumab | Phase II | Actionable | In a Phase II trial, combination Zejula (niraparib) and Keytruda (pembrolizumab) resulted in an objective response rate (ORR) of 56.3% (9/16; 2 complete, 7 partial responses), 19.7-mo median duration of response (mDR), and 8.4-mo median progression-free survival (mPFS) in non-small cell lung cancer patients with a CD274 (PD-L1) TPS>=50%, and an ORR of 20% (4/20; 4 partial responses), 9.4-mo mDR, and 4.2-mo mPFS in patients with a CD274 (PD-L1) TPS=1-49% (PMID: 34478166; NCT03308942). | 34478166 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03308942 | Phase II | Niraparib Niraparib + Pembrolizumab Dostarlimab-gxly + Niraparib | Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants | Completed | USA | 0 |
| NCT04475939 | Phase III | Pembrolizumab Niraparib + Pembrolizumab | Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo and Pembrolizumab as Maintenance Therapy (ZEAL-1L) | Recruiting | USA | 22 |
| NCT02657889 | Phase Ib/II | Niraparib + Pembrolizumab | Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer (TOPACIO) | Completed | USA | 0 |
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