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) 30 Zejula (niraparib) binds to and inhibits PARP, which may result in the accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved for use as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy, and as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring deleterious or suspected deleterious germline BRCA mutations and in complete or partial response to platinum-based chemotherapy (FDA.gov).
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 147 PD-L1/PD-1 antibody 117 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 SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-expressing NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemotherapy in NSCLC, 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 CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, and in combination with chemoradiation for 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
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
NCT04475939 Phase III Pembrolizumab Niraparib + Pembrolizumab Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo and Pembrolizumab as Maintenance Therapy (ZEAL-1L) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUS 18


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