Table 1 Studies of approved PD-1 inhibitors for advanced or metastatic gastric and GEJ cancers (FDA or Japan)
Trial | ATTRACTION-2 | KEYNOTE-062 Arm 1 | KEYNOTE-059 Cohort 1 | CT01876511 Cohort C |
|---|---|---|---|---|
PD-1 inhibitor | Nivolumab | Pembrolizumab | Pembrolizumab | Pembrolizumab |
Treatment line | 3rd or later | 1st | 3rd or later | 2nd or later |
Phase | III | III | II | II |
Allocation | Randomized, double-blind | Randomized | Single arm | Single arm |
PD-L1 status | not assessed | positive | positive/negative | not assessed |
MS status | not assessed | not assessed | not assessed | MSI |
Sample size | Nivolumab: 330 (total: 493) | 254 | 259 | 47 |
ECOG PS | 0–1 | 0–1 | 0–1 | 0–1 |
% Asian | 100% | 27% | < 23% | 4.3% |
ORR | 11.2% | 15% | 11.6% | 47% |
Median OS (months) | 5.3 | 10.6 | 5.6 | not reached |
Reference | [11] | [18] | [14] | [19] |