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PMID
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Title Keytruda (pembrolizumab) FDA Drug Label
Journal
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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
Drug Name Trade Name Synonyms Drug Classes Drug Description
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).
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
Unknown unknown endometrial carcinoma not applicable Lenvatinib + Pembrolizumab FDA approved Actionable In a Phase II trial (Study 111/KEYNOTE-146) that supported FDA approval, Lenvima (lenvatinib) and Keytruda (pembrolizumab) combination treatment resulted in an objective response rate of 35.6% (16/45) in patients with endometrial carcinoma that was not MSI-H or dMMR (PMID: 30922731; NCT02501096). detail... detail... 30922731
Unknown unknown lung squamous cell carcinoma not applicable Carboplatin + Nab-paclitaxel + Pembrolizumab FDA approved Actionable In a Phase III trial (KEYNOTE-407) that supported FDA approval, Keytruda (pembrolizumab) in combination with chemotherapy consisted of carboplatin and paclitaxel or nab-paclitaxel significantly improved overall survival (15.9 vs 11.3 months), progression-free survival (6.4 vs 4.8 months), and overall response rate (58% vs 35%) compared to placebo plus chemotherapy in patients with untreated metastatic squamous non-small cell lung cancer (J Clin Oncol 36, no. 15_suppl, 105-105; NCT02775435). detail... detail...
Unknown unknown bladder carcinoma in situ not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-057) that supported FDA approval, Keytruda (pembrolizumab) treatment demonstrated safety and efficacy, resulted in a 3-month complete response rate of 40.2% (41/102), with a median duration of follow-up of 15.8 months in patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are unable or refuse to undergo cystectomy (J Clin Onc 37, no. 15_suppl (May 20, 2019) 4530-4530; NCT02625961). detail... detail...
Unknown unknown head and neck squamous cell carcinoma not applicable Cisplatin + Fluorouracil + Pembrolizumab FDA approved Actionable In a Phase III trial (KEYNOTE-048) that supported FDA approval, Keytruda (pembrolizumab) in combination with platinum and Adrucil (fluorouracil) significantly improved overall survival compared to Erbitux (cetuximab) plus chemotherapy (13.0 vs 10.7 months, HR=0.77, p=0.0067) in patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (J Clin Oncol 37, no. 15_suppl (May 20 2019) 6000-6000; NCT02358031). detail... detail...
Unknown unknown melanoma not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-002) that supported FDA approval, treatment with Keytruda (pembrolizumab) resulted in improved progression-free survival (PFS) compared to chemotherapy in patients with Yervoy (ipilimumab)-refractory melanoma, with a HR of 0.57 (p<0.0001) in the 2mg/kg group and a HR of 0.50 (p<0.0001) in the 10mg/kg group (PMID: 26115796; NCT01704287). detail... 26115796
Unknown unknown renal cell carcinoma not applicable Axitinib + Pembrolizumab FDA approved Actionable In a Phase III trial (KEYNOTE-426) that supported FDA approval, the combination therapy of Keytruda (pembrolizumab) and Inlyta (axitinib) resulted in a greater 12-month overall survival rate (89.9% vs 78.3%), median progression-free survival (15.1mo vs 11.1mo), and objective response rate (59.3% vs 35.7%) compared to treatment with Sutent (sunitinib) in patients with untreated advanced renal cell carcinoma (PMID: 30779529; NCT02853331). detail... 30779529
Unknown unknown melanoma not applicable Pembrolizumab FDA approved Actionable In a Phase III trial (KEYNOTE-006) that supported FDA approval, treatment with Keytruda (pembrolizumab) resulted in improved progression-free survival (PFS) and overall survival (OS) in patients with metastatic melanoma, with a 6-month PFS rate of 47.3% for the every 2 week schedule and 46.4% for the every 3 week schedule versus 26.5% with Yervoy (ipilimumab) (PMID: 25891173; NCT01866319). 25891173 detail...
Unknown unknown Hodgkin's lymphoma not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-087) that supported FDA approval, Keytrude (pembrolizumab) treatment resulted in an overall response rate of 69% (145/210) in patients with relapsed or refractory classical Hodgkin lymphoma (PMID: 28441111; NCT02453594). detail... 28441111
Unknown unknown primary mediastinal B-cell lymphoma not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-170) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 45% (24/53) in patients with primary mediastinal large B-cell lymphoma, with a complete response rate of 13% (7/53), and a median progression-free survival of 5.5 months (ASH Annual Meeting Dec 2018, Session 626, abstract 228; NCT02576990). detail... detail... detail...
Unknown unknown skin squamous cell carcinoma not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-629) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 34.3% (36/105, 4 complete responses, 32 partial responses) and a disease control rate of 52.4% (55/105) in patients with recurrent or metastatic cutaneous squamous cell carcinoma, with median duration of response not reached and a median progression-free survival of 6.9 months (Ann Oncol (Oct 2019) 30 (Suppl_5): V908; NCT03284424). detail... detail...
Unknown unknown transitional cell carcinoma not applicable Pembrolizumab FDA approved Actionable In a Phase III (KEYNOTE-045) trial that supported FDA approval, treatment with Keytruda (pembrolizumab) resulted in improved median overall survival (10.3 vs 7.4 months, p=0.002) and objective response rate (21.1% vs 11.4%) compared to chemotherapy in patients with platinum-refractory advanced urothelial carcinoma (PMID: 28212060; NCT02256436). detail... 28212060
Unknown unknown lung squamous cell carcinoma not applicable Carboplatin + Paclitaxel + Pembrolizumab FDA approved Actionable In a Phase III trial (KEYNOTE-407) that supported FDA approval, Keytruda (pembrolizumab) in combination with chemotherapy consisted of carboplatin and paclitaxel or nab-paclitaxel significantly improved overall survival (15.9 vs 11.3 months), progression-free survival (6.4 vs 4.8 months), and overall response rate (58% vs 35%) compared to placebo plus chemotherapy in patients with untreated metastatic squamous non-small cell lung cancer (J Clin Oncol 36, no. 15_suppl, 105-105; NCT02775435). detail... detail...
Unknown unknown Merkel cell carcinoma not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-017) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in a confirmed objective response rate of 50% (21/42, complete response 19%, partial response 31%) in patients with advanced Merkel cell carcinoma naive to systemic therapy (J Clin Oncol 36, no. 15_suppl (May 20 2018) 9506-9506; NCT02267603). detail... detail...
Unknown unknown head and neck squamous cell carcinoma not applicable Pembrolizumab FDA approved Actionable In a Phase Ib trial (KEYNOTE-012) that supported FDA approval, treatment with Keytruda (pembrolizumab) resulted in an objective response rate of 18% (24/132; 4 complete response, 20 partial response) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (PMID: 27247226; NCT01848834). detail... detail... 27247226
Unknown unknown melanoma not applicable Pembrolizumab FDA approved Actionable In a Phase III trial (KEYNOTE-054) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in significantly improved recurrence-free survival rate at 1 year (75.4% vs 61.0%, HR=0.57, p<0.001) compared to placebo in patients with resected, high-risk stage III melanoma (PMID: 29658430; NCT02362594). 29658430 detail...
Unknown unknown hepatocellular carcinoma not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-224) that suported FDA approval, Keytruda (pembrolizumab) treatment resulted in an overall response rate of 17% (18/104, 1 complete response, 17 partial response), and stable disease in 44% (46/104) of patients with hepatocellular carcinoma previously treated with Nexavar (sorafenib), with a median progression-free survival of 4.8 months (PMID: 29875066; NCT02702414). detail... 29875066
Unknown unknown lung small cell carcinoma not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-158) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 18.7% (20/107) in patients with advanced small-cell lung cancer, with a median progression-free survival of 2.0 months (J Clin Oncol 36, no. 15_suppl (May 20 2018) 8506-8506; NCT02628067). detail... detail...
Unknown unknown head and neck squamous cell carcinoma not applicable Carboplatin + Fluorouracil + Pembrolizumab FDA approved Actionable In a Phase III trial (KEYNOTE-048) that supported FDA approval, Keytruda (pembrolizumab) in combination with platinum and Adrucil (fluorouracil) significantly improved overall survival compared to Erbitux (cetuximab) plus chemotherapy (13.0 vs 10.7 months, HR=0.77, p=0.0067) in patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (J Clin Oncol 37, no. 15_suppl (May 20 2019) 6000-6000; NCT02358031). detail... detail...