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Table 2 The key reported clinical trials of of PD-1/PD-L inhibitors in patients with gastric cancer

From: PD-1/PD-L blockade in gastrointestinal cancers: lessons learned and the road toward precision immunotherapy

Tumor type Target Drug Phase and identification Sample size Clinical end point TRAEs Reference
GC/GEC PD-1 Nivolumab Phase III
NCT02267343
493 ORR 11.2% (nivolumab), 0% (placebo); median PFS 1.61 months (nivolumab), 1.45 months (placebo); median OS 5.32 months (nivolumab), 4.14 months (placebo) Grade ≥3 11.5% (nivolumab), 5.5% (placebo) ASCO 2017 [36]
GC/GEC PD-1 Nivolumab Phase I/II
NCT01928394
59 ORR 12% (all), 18% (PD-L1+), 12% (PD-L1); median DOR 7.1 months; median OS 6.8 months; 12-month OS rate 38% All grade: 66%; grades 3–4 14%, including pneumonitis, fatigue, diarrhea, vomiting, hypothyroidism, increased aspartate and alanine aminotransferase and alkaline phosphatase levels. ASCO 2016 [78]
GC/GEC PD-L1 Avelumab Phase I
NCT01772004
75 ORR 15% (2 line group), 7% (switch-maintenance group); median PFS in 2 line group 36.0 weeks (PD-L1+), 11.6 weeks (PD-L1); median PFS in switch-maintenance group 17.6 weeks (PD-L1+), 11.6 weeks (PD-L1) TR-TEAEs of any grade 62.7%, including infusion-related reaction; grade ≥3 TR-TEAE 12.0%, including fatigue, thrombocytopenia, and anemia ASCO 2016 [152]
GC PD-1 Pembrolizumab Phase II
NCT02335411
259 ORR 11.2% (all), 14.9% (3 line), 7.2% (4 line), 15.5% (PD-L1+), 5.5% (PD-L1), 21.3% (3 line with PD-L1+), 6.9% (4 line with PD-L1+); SD 17%; PD 55.6%; Median DOR: 8.1 months Grades 3–5 16.6% ASCO 2017 [153]
GC PD-1 Pembrolizumab + 5-fluorouracil + cisplatin Phase II
NCT02335411
25 ORR 60% (all), 68.8% (PD-L1+), 37.5% (PD-L1); SD 32%; PD 55.6%; median DOR 4.6 months (all), 4.6 months (PD-L1+), 5.4 months (PD-L1); median PFS 6.6 months; median OS13.8 months Grades 3–4 76% ASCO 2017 [154]
GC PD-1 Pembrolizumab Phase I
NCT01848834
36 ORR 22% (central review), 33% (investigator review) Any grade 67%, including fatigue, decreased appetite, hypothyroidism, pruritus and arthralgia; 5 (13%) patients had a total of 6 grades 3–4 TRAEs, including fatigue, pemphigoid, hypothyroidism, peripheral sensory neuropathy, pneumonitis. Lancet Oncology 2016 [35]
GC PD-1 Nivolumab; nivolumab + ipilimumab Phase I/II
NCT01928394
154 ORR 16% (all), 14% (nivolumab 3 mg/kg), 26% (nivolumab 1 mg/kg + ipilimumab 3 mg/kg), 10% (nivolumab 3 mg/kg + ipilimumab 1 mg/kg); DCR 38%; 12-month OS rate 36% (nivolumab 3 mg/kg), 34% (nivolumab 1 mg/kg + ipilimumab 3 mg/kg), NA (nivolumab 3 mg/kg + ipilimumab 1 mg/kg); median OS 5.0 months (nivolumab 3 mg/kg), 6.9 months (nivolumab 1 mg/kg + ipilimumab 3 mg/kg), 4.8 months (nivolumab 3 mg/kg + ipilimumab 1 mg/kg) Any grade 70% (nivolumab 3 mg/kg), 84% (nivolumab 1 mg/kg + ipilimumab 3 mg/kg), 75% (nivolumab 3 mg/kg + ipilimumab 1 mg/kg); grades 3–4: 17% (nivolumab 3 mg/kg), 45% (nivolumab 1 mg/kg + ipilimumab 3 mg/kg), 27% (nivolumab 3 mg/kg + ipilimumab 1 mg/kg) ASCO 2016 [155]
GC PD-1 Pembrolizumab Phase I
NCT01848834
39 ORR 22% (central review), 33% (investigator review); median DOR 24 weeks; 6-month PFS rate 24%; 6-month OS rate 69% 4 patients experienced 5 total grades 3–5 TRAEs, including peripheral sensory neuropathy, fatigue, decreased appetite, hypoxia, and pneumonitis; 1 patient experienced drug-related death (hypoxia) ASCO 2015 [156]
GC PD-L1 Avelumab Phase I
NCT01943461
11 PR 3 patients All grades 90.9%, including infusion-related reactions, hyperthyroidism, and pruritus ASCO 2015 [129]
GC PD-L1 Durvalumab Phase I
NCT01693562
16 ORR 25% Any grade (multiple cancer types) 33%, including fatigue, nausea, rash, vomiting, and pyrexia; grade ≥3 (multiple cancer types) 7% ASCO 2014 [61]
GC PD-L1 Atezolizumab Phase I
NCT01375842
1 PR 1patient Grades 3–4 (multiple cancer types) 39% ASCO 2013 [134]