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PMID
Authors
Title Keytruda (pembrolizumab) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Pembrolizumab Pembrolizumab 327 582
Drug Name Trade Name Synonyms Drug Classes Drug Description
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 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, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, 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 chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
MLH1 negative Advanced Solid Tumor sensitive Pembrolizumab FDA approved Actionable In a combined analysis of 5 trials that supported FDA approval, Keytruda (pembrolizumab) therapy resulted in an objective response rate of 39.6% (59/149) in advanced solid tumor patients with high levels of microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (PMID: 30787022; NCT01876511, NCT02460198, NCT01848834, NCT02054806, NCT02628067). detail... 30787022
CD274 positive esophagus squamous cell carcinoma sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KEYNOTE-181) that supported FDA approval, Keytruda (pembrolizumab) treatment as second-line therapy improved overall survival (OS) (9.3 vs 6.7 months, HR=0.69, p=0.0074) and 12-month OS rate (43% vs 20%) compared to chemotherapy in patients with esophagus squamous cell carcinoma with a CPS of 10 or higher (PMID: 33026938; NCT02564263). detail... detail... 33026938
MSH2 negative endometrial carcinoma sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase II trial (KEYNOTE-158) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 48% (38/79, 11 complete responses, 27 partial responses) in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial carcinoma, with a median progression-free survival of 13.1 months (PMID: 34990208; NCT02628067). detail... 34990208 detail...
MSH6 negative colorectal cancer sensitive Pembrolizumab FDA approved Actionable In a Phase III (KEYNOTE-177) trial that supported FDA approval, Keytruda (pembrolizumab) treatment as first-line therapy significantly improved median progression-free survival (16.5 vs 8.2 mo, HR=0.60, p=0.0002) compared to chemotherapy in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) colorectal cancer (PMID: 33264544; NCT02563002). 33264544 detail...
PMS2 negative Advanced Solid Tumor sensitive Pembrolizumab FDA approved Actionable In a combined analysis of 5 trials that supported FDA approval, Keytruda (pembrolizumab) therapy resulted in an objective response rate of 39.6% (59/149) in advanced solid tumor patients with high levels of microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (PMID: 30787022; NCT01876511, NCT02460198, NCT01848834, NCT02054806, NCT02628067). detail... 30787022
CD274 positive lung non-small cell carcinoma sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase II/III trial (KEYNOTE-010) that supported FDA approval, treatment with Keytruda (pembrolizumab) resulted in improved overall survival (10.4 months at 2mg/kg, 12.7 months at 10mg/kg, vs 8.5 months) compared to chemotherapy in previously treated non-small cell lung cancer patients with CD274 (PD-L1) expression in over 1% of tumor cells (PMID: 26712084, PMID: 27026676, PMID: 27718847; NCT01905657). 26712084 27026676 27718847 detail...
MSH6 negative Advanced Solid Tumor sensitive Pembrolizumab FDA approved Actionable In a combined analysis of 5 trials that supported FDA approval, Keytruda (pembrolizumab) therapy resulted in an objective response rate of 39.6% (59/149) in advanced solid tumor patients with high levels of microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (PMID: 30787022; NCT01876511, NCT02460198, NCT01848834, NCT02054806, NCT02628067). detail... 30787022
CD274 positive triple-receptor negative breast cancer sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KEYNOTE-355) that supported FDA approval, addition of Keytruda (pembrolizumab) to chemotherapy significantly improved progression-free survival compared to chemotherapy alone (9.7 vs 5.6, HR=0.65, p=0.0012) in patients with locally recurrent or metastatic triple-receptor negative breast cancer expressing CD274 (PD-L1, CPS>=10), as determined by an FDA-approved test (Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 1000-1000; NCT02819518). detail... detail... detail...
CD274 positive cervical cancer sensitive Bevacizumab + Cisplatin + Paclitaxel + Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KEYNOTE-826) that supported FDA approval, first-line Keytruda (pembrolizumab) in combination with platinum-based chemotherapy (Platinol (cisplatin) or Paraplatin (carboplatin) plus Taxol (paclitaxel)), with or without Avastin (bevacizumab), improved progression-free survival (10.4 vs 8.1 mo, HR 0.62, p<0.001) compared to placebo in patients with CD274 (PD-L1)-positive (CPS>=1), persistent, recurrent or metastatic cervical cancer (PMID: 34534429; NCT03635567). 34534429 detail... detail...
CD274 positive cervical cancer sensitive Bevacizumab + Carboplatin + Paclitaxel + Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KEYNOTE-826) that supported FDA approval, first-line Keytruda (pembrolizumab) in combination with platinum-based chemotherapy (Platinol (cisplatin) or Paraplatin (carboplatin) plus Taxol (paclitaxel)), with or without Avastin (bevacizumab), improved progression-free survival (10.4 vs 8.1 mo, HR 0.62, p<0.001) compared to placebo in patients with CD274 (PD-L1)-positive (CPS>=1), persistent, recurrent or metastatic cervical cancer (PMID: 34534429; NCT03635567). detail... detail... 34534429
MSH2 negative colorectal cancer sensitive Pembrolizumab FDA approved Actionable In a Phase III (KEYNOTE-177) trial that supported FDA approval, Keytruda (pembrolizumab) treatment as first-line therapy significantly improved median progression-free survival (16.5 vs 8.2 mo, HR=0.60, p=0.0002) compared to chemotherapy in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) colorectal cancer (PMID: 33264544; NCT02563002). 33264544 detail...
MLH1 negative endometrial carcinoma sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase II trial (KEYNOTE-158) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 48% (38/79, 11 complete responses, 27 partial responses) in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial carcinoma, with a median progression-free survival of 13.1 months (PMID: 34990208; NCT02628067). detail... 34990208 detail...
PMS2 negative endometrial carcinoma sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase II trial (KEYNOTE-158) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 48% (38/79, 11 complete responses, 27 partial responses) in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial carcinoma, with a median progression-free survival of 13.1 months (PMID: 34990208; NCT02628067). detail... detail... 34990208
CD274 positive cervical cancer sensitive Carboplatin + Paclitaxel + Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KEYNOTE-826) that supported FDA approval, first-line Keytruda (pembrolizumab) in combination with platinum-based chemotherapy (Platinol (cisplatin) or Paraplatin (carboplatin) plus Taxol (paclitaxel)), with or without Avastin (bevacizumab), improved progression-free survival (10.4 vs 8.1 mo, HR 0.62, p<0.001) compared to placebo in patients with CD274 (PD-L1)-positive (CPS>=1), persistent, recurrent or metastatic cervical cancer (PMID: 34534429; NCT03635567). detail... 34534429 detail...
CD274 positive head and neck squamous cell carcinoma sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KEYNOTE-048) that supported FDA approval, Keytruda (pembrolizumab) monotherapy significantly improved overall survival compared to Erbitux (cetuximab) plus chemotherapy (12.3 vs 10.3 months, HR=0.78, p=0.0086) in patients with CD274 (PD-L1)-positive (CPS >=1) metastatic or unresectable recurrent head and neck squamous cell carcinoma (PMID: 31679945; NCT02358031). detail... 31679945 detail...
MSH6 negative endometrial carcinoma sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase II trial (KEYNOTE-158) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 48% (38/79, 11 complete responses, 27 partial responses) in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial carcinoma, with a median progression-free survival of 13.1 months (PMID: 34990208; NCT02628067). detail... detail... 34990208
CD274 positive cervical cancer sensitive Cisplatin + Paclitaxel + Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KEYNOTE-826) that supported FDA approval, first-line Keytruda (pembrolizumab) in combination with platinum-based chemotherapy (Platinol (cisplatin) or Paraplatin (carboplatin) plus Taxol (paclitaxel)), with or without Avastin (bevacizumab), improved progression-free survival (10.4 vs 8.1 mo, HR 0.62, p<0.001) compared to placebo in patients with CD274 (PD-L1)-positive (CPS>=1), persistent, recurrent or metastatic cervical cancer (PMID: 34534429; NCT03635567). 34534429 detail... detail...
MLH1 negative colorectal cancer sensitive Pembrolizumab FDA approved Actionable In a Phase III (KEYNOTE-177) trial that supported FDA approval, Keytruda (pembrolizumab) treatment as first-line therapy significantly improved median progression-free survival (16.5 vs 8.2 mo, HR=0.60, p=0.0002) compared to chemotherapy in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) colorectal cancer (PMID: 33264544; NCT02563002). 33264544 detail...
CD274 positive cervical cancer sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase II trial (KEYNOTE-158) that supported FDA approval, treatment with Keytruda (pembrolizumab) resulted in an objective response rate of 14.6% (12/82) in patients with CD274 (PD-L1)-positive (CPS >=1) advanced cervical cancer, including 3 with a complete response and 9 with a partial response (PMID: 30943124; NCT02628067). 30943124 detail... detail...
MSH2 negative Advanced Solid Tumor sensitive Pembrolizumab FDA approved Actionable In a combined analysis of 5 trials that supported FDA approval, Keytruda (pembrolizumab) therapy resulted in an objective response rate of 39.6% (59/149) in advanced solid tumor patients with high levels of microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (PMID: 30787022; NCT01876511, NCT02460198, NCT01848834, NCT02054806, NCT02628067). detail... 30787022
PMS2 negative colorectal cancer sensitive Pembrolizumab FDA approved Actionable In a Phase III (KEYNOTE-177) trial that supported FDA approval, Keytruda (pembrolizumab) treatment as first-line therapy significantly improved median progression-free survival (16.5 vs 8.2 mo, HR=0.60, p=0.0002) compared to chemotherapy in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) colorectal cancer (PMID: 33264544; NCT02563002). detail... 33264544