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. 2020 Apr 15;11:508. doi: 10.3389/fimmu.2020.00508

Table 1.

Summary of Food and Drug Administration approved immune checkpoint inhibitors in GI cancers.

Drug(s) Target(s) Therapy modality Tumor type Details Objective response rate (%) FDA approved Year Clinical trial ClinicalTrials.gov identifier References (PMID)
Pembrolizumab (Keytruda) PD-1 Humanized monocolonal antibody Gastric Cancer Patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 60.0% (combination with cisplatin) 25.8% (single agent) 2017 KEYNOTE-059 NCT02335411 30911859
Liver Cancer Patients with hepatocellular carcinoma who previously received sorafenib 17% 2018 KEYNOTE-224 NCT02702414 29875066
Colorectal Cancer Patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan
Also approved for any solid tumor that has tested positive for MSI-H or dMMR in patients who have had prior treatment and have no satisfactory alternative treatment options
Colorectal Cancer: 40% (dMMR) 0% (proficient MMR)
Non-colorectal Cancers: 70% (dMMR)
2017 KEYNOTE NCT01876511 26028255
Nivolumab (Opdivo) PD-1 Humanized monocolonal antibody Liver Cancer Patients with advanced hepatocellular carcinoma. The approval covers the use of nivolumab in patients who have previously received sorafenib 15, 20% 2017 CheckMate 040 NCT01658878 28434648
Colorectal Cancer Patients with MSI-H or dMMR metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan 68.9% 2017 CheckMate 142 NCT02060188 28734759
Nivolumab (Opdivo) Ipilimumab (Yervoy) PD-1 CTLA-4 Humanized monocolonal antibodies Colorectal Cancer Patients with MSI-H or dMMR metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. 55% 2018 CheckMate 142 NCT02060188 29355075