Characteristics of the included studies
Drug name | Trial name/Registry number | Design | Indications | Approval data | Ref |
Trastuzumab emtansine | KATHERINE NCT01772472 | Phase III RCT | HER2-positive early breast cancer after receiving neoadjuvant therapy containing a taxane (with or without anthracycline) and trastuzumab | 2019 by FDA 2019 by EMA | 15 |
EMILIA NCT00829166 | Phase III RCT | HER2-positive advanced breast cancer second line | 2013 by FDA 2013 by EMA | 16–18 | |
Enfortumab vedotin | EV-301 NCT03474107 | Phase III RCT | Locally advanced or metastatic urothelial carcinoma | 2019 by FDA 2022 by EMA | 19 |
Trastuzumab deruxtecan | DESTINY-Breast01 NCT03248492 | Phase II SAT | HER2-positive metastatic breast cancer third line | 2019 by FDA 2020 by EMA | 20 |
DESTINY-Breast03 NCT03529110 | Phase III RCT | HER2-positive metastatic breast cancer second line | 2022 by FDA 2022 by EMA 2023 by NMPA | 21 22 | |
DESTINY-Breast04 NCT03734029 | Phase III RCT | HER2-low metastatic breast cancer | 2022 by FDA 2022 by EMA 2023 by NMPA | 23 | |
DESTINY-Gastric01 NCT03329690 | Phase II RCT | HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after a prior trastuzumab-based regimen | 2021 by FDA 2022 by EMA | 24 | |
DESTINY-Lung02 NCT04644237 | Phase II SAT | Metastatic HER2-mutant NSCLC second line | 2022 by FDA | 25 | |
Sacituzumab govitecan | ASCENT NCT02574455 | Phase III RCT | Relapsed or refractory metastatic triple-negative breast cancer | 2020 by FDA 2021 by EMA 2022 by NMPA | 26 27 |
TROPiCS-02 NCT03901339 | Phase III RCT | Endocrine-resistant, chemotherapy-treated HR+/HER2− locally recurrent inoperable or metastatic breast cancer | 2023 by FDA 2023 by EMA | 28 29 | |
TROPHY-U-01 NCT03547973 | Phase II RCT | Metastatic urothelial carcinoma | 2021 by FDA | 30 | |
Cetuximab saratolacan | – NCT02422979 | Phase II SAT | Recurrent head and neck squamous cell carcinoma | 2020 by PMDA | 31 |
Disitamab vedotin | – NCT03556345 | Phase II SAT | HER2-overexpressing, locally advanced or metastatic gastric or gastro-oesophageal junction cancer | 2021 by NMPA | 32 |
– NCT03507166 | Phase II SAT | HER2+ locally advanced or metastatic urothelial carcinoma | 2022 by NMPA | 33 | |
Tisotumab vedotin | innovaTV 204 NCT03438396 | Phase II SAT | Recurrent or metastatic cervical cancer | 2021 by FDA | 34 |
Mirvetuximab soravtansine | SORAYA NCT04296890 | Phase II SAT | FRa-high, platinum-resistant epithelial ovarian cancer | 2022 by FDA | 35 |
EMA, European Medicines Agency; FDA, Food and Drug Administration; HRQoL, health-related quality of life; NMPA, National Medical Products Administration; NSCLC, non-small cell lung cancer; PMDA, Japanese Pharmaceuticals and Medical Devices Agency; RCT, randomised control trial; SAT, single-arm trial.