Table 3.
Selected past and ongoing prospective clinical trials on targeted therapy in HER2-positive metastatic CRC.
| Trial | Phase | Sample size | Treatment arm(s) | Line of treatment | ORR (%) | mPFS (months) | mOS (months) |
|---|---|---|---|---|---|---|---|
| Combined HER2 inhibition | |||||||
| HERACLES108 | II | 32 | Trastuzumab + lapatinib | ⩾2L | 28 | 4.7 | 10.0 |
| MOUNTAINEER107 | II | 86 | Trastuzumab + tucatinib | ⩾2L | 38.1 | 8.2 | 24.1 |
| HER2-FUSCC-G109 | II | 11 | Trastuzumab + pyrotinib | ⩾2L | 45.5 | 7.8 | 15.0 |
| Yuan et al.110 | II | 11 | Trastuzumab + pyrotinib | ⩾1L | 27 | – | – |
| MyPathway111 | II | 84 | Pertuzumab + trastuzumab | ⩾2L | 26.2 | – | – |
| TRIUMPH112 | II | 27 | Pertuzumab + trastuzumab | ⩾2L | 30 | 4.0 | 10.1 |
| TAPUR113 | II | 28 | Pertuzumab + trastuzumab | ⩾2L | 14 | 4.0 | – |
| NSABP FC-11114 | II | 21 | Neratinib + cetuximab | ⩾2L (prior anti-HER2 not allowed) | 33 | – | – |
| S1613 (NCT03365882) | II | 240 (in 2 arms) | Pertuzumab + trastuzumab versus cetuximab + irinotecan | ⩾2L | – | – | – |
| Anti-HER2 antibody–drug conjugates | |||||||
| HERACLES-B115 | II | 31 | Pertuzumab + T-DM1 | ⩾2L | 9.7 | 4.1 | |
| DESTINY-CRC01116 | II | 53 | T-DXd | ⩾3L | 45.3 | 6.9 | 15.5 |
| DESTINY-CRC02 (NCT04744831) | II | 122 | T-DXd | ⩾2L (prior anti-HER2 allowed) | – | – | – |
CRC, colorectal cancer; HER2, human epidermal growth factor receptor 2; mOS, median overall survival; mPFS, median progression-free survival; ORR, objective response rate; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan or DS-8201; 2L, second-line therapy; 3L, third-line therapy.