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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]