Introduction
Study name | Therapeutic agent | Phase | Histology | Therapy line | Control group | Findings | Population | Approval | Reference number |
---|---|---|---|---|---|---|---|---|---|
ATTRACTION‑2 | Nivolumab | III | Advanced gastric or GEJ cancer | ≥ 3 | Placebo | Median OS: 5.26 vs 4.14 months (HR 0.63, 95% CI 0.51–0.78); p < 0.0001 | Asia | 2017–2019 (PD-L1 independent): Japan, South Korea, Taiwan, Singapore and Switzerland | |
KEYNOTE-059 | Pembrolizumab | II | Advanced gastric and GEJ cancer | ≥ 2 | No control group | ORR: 15.5%; 95% CI 10.1–22.4% | North and South America, Asia, Europe | 2017 (CPS ≥ 1): FDA → 07/2021 withdrawal by company | |
CheckMate 649 | Nivolumab + chemotherapy; (ipilimumab + nivolumab) | III | Advanced non-HER2-positive gastric, GEJ or esophageal adenocarcinoma | 1 | Chemotherapy | Median OS: nivo + CHT 14.4 (95% CI 13.1–16.2) vs CHT 11.1 months (95% CI 10.0–12.1) in PD-L1 CPS ≥ 5 pts | North and South America, Australia, Asia, Europe | 2021 (PD-L1 independent): FDA | |
5 trials (KEYNOTE: 016, 164, 012, 028, and 158) | Pembrolizumab | Ib, II | 149 patients with MSI‑H cancers | ≥ 2 | No control group | ORR (retrospective analysis): 39.6% (95% CI: 31.7, 47.9) | North and South America, Australia, Asia, Europe | 2017 (MSI‑H; without satisfactory alternative treatment options): FDA | [11] |
KEYNOTE-158 | Pembrolizumab | II | MSI‑H advanced non-colorectal cancer | ≥ 2 | No control group | TMB‑H (retrospective analysis): ORR: 29% (95% CI 21–39); DoR: not reached | North and South America, Australia, Asia, Europe | 2020 (TMB‑H; without satisfactory alternative treatment options): FDA | [12] |
KEYNOTE-811 | Pembrolizumab + trastuzumab and chemotherapy | III | HER2-positive metastatic gastric/GEJ cancer | 1 | Placebo + trastuzumab and chemotherapy | ORR: pembro 74% (95% CI 66–82) vs placebo 52% (95% CI 43–61) arm; one-sided p-value < 0.0001 | North and South America, Australia, Asia, Europe | 2021 (HER2-positive, PD-L1 independent): FDA | |
DESTINY-Gastric01 | Trastuzumab deruxtecan | II | HER2-positive advanced gastric/GEJ cancer | ≥ 3 | Chemotherapy | Median OS: 12.5 (95% CI 9.6–14.3) vs 8.4 months (95% CI 6.9–10.7); HR 0.59 (95% CI 0.39–0.88); p = 0.0097 | Asia | 2021 (HER2-positive; prior trastuzumab-based regimen): FDA, Japan | |
FIGHT | Bemarituzumab + chemotherapy | II | FGFR2b-positive, HER2-negative advanced gastric/GEJ cancer | 1 | Chemotherapy + placebo | Median OS: 25.4 months (95% CI: 13.8, n.r.) vs 11.1 months (95% CI: 8.4, 13.8) for pts with ≥ 10% FGFR2b+; HR 0.41 (95% CI 0.23–0.74) | North America, Australia, Asia, Europe | 2021 (FGFR2b-positive, HER2-negative): FDA |