Table 5 Clinical trials of combined immunotherapy in HER2-positive advanced G/GEJ adenocarcinoma
Trial/Author Year | Phase Status | Population | Intervention | N | Results | Adverse events |
|---|---|---|---|---|---|---|
Janjigian YY 2020 [102] | II Completed | First-line HER2-positive G/GEJ adenocarcinoma | Pembrolizumab + Trastuzumab + Chemotherapy | 37 | mOS 27.3 m mPFS 13.0 m | Grade 3 49% Grade 4 8% |
PANTHERA 2020 [104] | Ib-II Completed | First-line HER2-positive advanced GC | Pembrolizumab + Trastuzumab + chemotherapy | 43 | mOS 19.3 m mPFS 8.6 m | Grade 3 76.7% Grade 4 4.7% |
KEYNOTE-811 2021 [105] | III processing | First-line HER2-positive advanced GC | Pembrolizumab + Trastuzumab + chemotherapy Placebo + Trastuzumab + chemotherapy | 133 131 | RR 74% 52% | – |
ATTRACTION-2 2020 [106] | III Completed | Third-line and beyond HER2-positive G/GEJ adenocarcinoma | Nivolumab Placebo | 59 22 | mOS 8.3 m(P = 0.0006) 3.1 m mPFS 1.6 m(P = 0.0111) 1.5 m | – |
INTEGA/AIO STO 0217 2020 [107] | II processing | First-line HER2-positive advanced/metastatic GEA | Ipilimumab + Nivolumab + Trastuzumab 5-FU/Leucovorin + Oxaliplatin + Nivolumab + Trastuzumab | – | – | – |
KN026–203 [108] | II processing | Second-line and beyond HER2-positive G/GEJ adenocarcinoma, BC, other solid tumors | KN046 + KN026 | 24 | ORR 55.0% DCR 85.0% 6-month PFS rate 84.1% | Grade ≥ 3 16.7% |