Table 1:
Food and Drug Administration-approved immune checkpoint inhibitors in gastrointestinal cancers and their current indications
| Agent (dose) | Cancer type | PD-L1 status | FDA-approved indication |
|---|---|---|---|
| Pembrolizumab (200 mg every 3 weeks) | Any | Any | Patients with unresectable or metastatic MSI-high or mismatch repair-deficient tumors that have progressed following prior treatment and who have no satisfactory alternative options or colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan[7] |
| Esophageal | CPS ≥ 10 | Patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumor express PD-L1 (CPS ≥ 10) as determined by an FDA-approved test, with disease | |
| Gastric | CPS ≥ 1 | progression after one or more prior lines of systemic therapy[20,21] Patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2-targeted therapy[18] | |
| HCC | Any | Patients with HCC who have been treated with sorafenib[24] | |
| Nivolumab (240 mg every 2 weeks or 480 mg every 4 weeks) | Colorectal | Any | Patients with MSI-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan[9] |
| HCC | Any | Patients with HCC who have been previously treated with sorafenib[22] | |
| Nivolumab plus ipilumumab (nivolumab 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks) | Colorectal | Any | Patients with MSI-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan[10] |
CPS: Combined Positive Score, HCC: Hepatocellular carcinoma, MSI: Microsatellite instability, FDA: Food and Drug Administration, HER 2: Human epidermal growth factor receptor