Table I.
Summary of main clinical studies of anti-HER2 drugs in the treatment of HER2+ AGC.
| First author(s), year | Drug types | Drug name | Trial name/status | NCT Trial No. | Phase | Therapy | mOS, month | mPFS, month | ORR, % | Applicable stage | (Refs.) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Bang et al, 2010 | Anti-HER2 monoclonal antibody | Trastuzumab | ToGA-Completed | NCT01041404 | III | Trastuzumab + chemotherapy vs. chemotherapy | 13.8 vs. 11.1 | 6.7 vs. 5.5 | 47.3 vs. 34.5 | First-line | (16) |
| Makiyama et al, 2020 | Trastuzumab | T-ACT-Completed | - | II | Paclitaxel vs. trastuzumab + paclitaxel | 10.0 vs. 10.2 | 3.2 vs. 3.7 | 32 vs.33 | Second-line | (70) | |
| Janjigian et al, 2021 | Trastuzumab | KEYNOTE-811 Ongoing | NCT03615326 | III | Pembrolizumab + trastuzumab + chemotherapy vs. trastuzumab + chemotherapy | - | - | 74.4 vs. 51.9 | First-line | (35) | |
| Tabernero et al, 2018 | Pertuzumab | JACOB-Completed | NCT01774786 | III | Pertuzumab + trastuzumab + chemotherapy vs. placebo + trastuzumab + chemotherapy | 17.5 vs. 14.2 | 8.5 vs. 7.0 | 56.7 vs. 48.3 | First-line (failed) | (85) | |
| Catenaci et al, 2020 | Margetuximab | CP-MGAH22-Completed | NCT02689284 | IB/II | Margetuximab + pembrolizumab | - | - | - | Safety Assessment | (82) | |
| Thuss-Patience et al, 2017 | Anti-HER2 ADCs | T-DM1 | GATSBY-Completed | NCT01641939 | II/III | T-DM1 vs. taxane | 7.9 vs.8.6 | 2.9 vs. 2.7 | 19.6 vs. 20.6 | Second-line (faiedl) | (77) |
| Shitara et al, 2020 | DS-8201 | Completed | NCT03329690 | II | DS-8201 vs. chemotherapy | 12.5 vs. 8.4 | 5.6 vs. 3.5 | 51 vs. 14 | Posterior line | (20) | |
| Peng et al, 2021 | RC48 | RC48-C008 Completed | NCT03556345 | II | RC48 | 7.9 | 4.1 | 24.8 | Third-line | (21) | |
| Zhang et al, 2022 | ARX788 | - Completed | CTR20190639 | I | ARX788 | 10.7 | 4.1 | 37.9 | Posterior line | (106) | |
| Meric-Bemstam et al, 2021 | Bispecific antibody | ZW25 | - Ongoing | NCT02892123 | I | ZW25 vs. chemotherapy | - | - | 33 vs. 54 | Posterior line | (79) |
| Shen et al, 2022 | KN026 | - Ongoing | NCT04040699 | II | KN026 + KN046 | - | - | 77.8 | Posterior line | (115) | |
| Xu et al, 2023 | KN026 | - Completed | NCT03925974 | II | KN026 | - | - | 56 | Second-line | (112) | |
| Satoh et al, 2014 | Anti-HER2 TKI | Lapatinib | TyTan Completed | NCT00486954 | III | Lapatinib + paclitaxel vs. paclitaxel | 11 vs. 8.9 | 5.4 vs. 4.4 | - | Second-line | (119) |
| Hecht et al, 2016 | Lapatinib | TRIO-013/LOGIC Completed | NCT00680901 | III | CapeOx + lapatinib vs. placebo | 12.2 vs. 10.5 | 6.0 vs. 5.4 | 53 vs. 39 | First-line | (117) | |
| Liu et al, 2021 | Pyrotinib | - Completed | NCT03480256 | IB | Pyrotinib + SHR6390 | - | 3.83 | 38.9 | Posterior line | (126) | |
| Sang et al, 2021 | Varlitinib | - Completed | KCT0003583 | IB | Varlitinib + placebo | - | - | - | Second-line | (131) | |
| Tabernero et al, 2022 | Tucatinib | - ongoing | NCT04499924 | II | Tucatinib + trastuzumab + ramucirumab + paclitaxel | - | - | - | Second-line | (136) |
mOS, median overall survival; mPFS, median progression-free survival; ORR, objective response rate; AGC, advanced gastric cancer; HER2, human epidermal growth factor receptor 2; ADC, anti-drug conjugate.