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05 February 2022: Review Articles

A Review of Emerging Biomarkers for Immune Checkpoint Inhibitors in Tumors of the Gastrointestinal Tract

Xuqiang Liao 1AE* , Gao Li 1B* , Renzhong Cai 1AF* , Ru Chen 2AG*

DOI: 10.12659/MSM.935348

Med Sci Monit 2022; 28:e935348

Table 1 Published studies of immune checkpoint inhibitors for gastrointestinal cancers.

Tumor typeTarget/DrugTrail identifierPhaseSizeStudy designClinical efficacy
ESCC []77 PD-1/NivolumabONO-4538-07II64Single armORR=17% (11/64)
ESCC []78 PD-1/NivolumabATTRACTION-3III419Randomized, open-lableOS=11.6 months (nivolumab) vs 10.9 (chemotherapy)
ESCC []21 PD-1/PembrolizumabKEYNOTE-180II121Single armORR=9.9% (12/121)
GC/GEJC []55 PD-1/NivolumabATTRACTION-2III493Randomized, double-blindORR=11.2%(30/268); 1-year OS=26.2% (nivolumab) vs 10.9% (placebo)
GC/GEJC []79 PD-1/PembrolizumabKEYNOTE-059II259Single armORR=15.5% (PD-L1+) vs 5.5% (PD-L1−)
GC/GEJC []80 PD-1/PembrolizumabKEYNOTE-061III592Randomized, open-labelOS=9.1months (nivolumad) vs 8.3 months (paclitaxel)
PD-L1+ GC/GEJC []16 PD-1/PembrolizumabKEYNOTE-012Ib39Single armORR=22% (8/36)
dMMR/MSI-H CRC []41 PD-1/PembrolizumabCT01876511II28Single armORR=40% (dMMR/MSI-H) vs 0% (pMMR CRC)
dMMR/MSI-H tumors []42 PD-1/PembrolizumabCT01876511II86Single armORR=53%; CR=21%
dMMR/MSI-H CRC []45 PD-1/NivolumabCheckmate 142II74Single armORR=31.1% (23/74)
dMMR/MSI-H CRC []46 PD-1+CTLA-4/Nivolumab+ipilimumabCheckmate 142II119Single armORR=55% (65/119)
HCC []20 PD-1/NivolumabCheckmate 040I/II214Dose escalation and expansionORR=20% (42/214)
HCC []81 PD-1/PembrolizumabKEYNOTE-224II104Non-randomized, open-labelORR=17% (18/104)
HCC []82 PD-1/PembrolizumabKEYNOTE-240III413Randoimzed, double-blindOS=13.9months (pembrolizumab) vs 10.6 (placebo)
PDAC []83 PD-L1/MDX-1105NCT00729664I207Dose escalationORR in PDAC=0% (0/14)
PDAC []84 PD-1/PembrolizumabNCT02362048II77Randomized, open-labelORR=7.9%(with pembrolizumab) vs 0% (with acalabrutinib)
ESCC – esophageal squamous cell carcinoma; GC or GEJC – gastric or gastroesophageal junction cancer; CRC – colorectal cancer; HCC – hepatocellular carcinoma; PDAC – pancreatic ductal adenocarcinoma; PD-1 – programmed death-1; dMMR – DNA mismatch-repair defect; MSI-H – high microsatellite instability.

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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750