Table 4.
Recent and ongoing trials with anti-HER2 combinations in mCRC.
| Trial | Phase | Treatment | HER2 amplification detection | N° patients | ORR (%) | mPFS months | mOS months |
|---|---|---|---|---|---|---|---|
| HERACLES A
Siena 2016 |
II | Trastuzumab + lapatinib | IHC3+ in 50% of cells or IHC2+/FISH+ (HER2:CEP17 ratio > 2 in > 50% of cells) |
27 | 30 | 5.4 | 14 |
| HERACLES B
Sartore Bianchi 2019 |
II | T-DM1 + pertuzumab | IHC3+ in 50% of cells or IHC2+/FISH+ (HER2:CEP17 ratio > 2 in > 50% of cells) |
30 | 10 | 4.8 | - |
| HERACLES RESCUE
(ongoing) |
II | T-DM1 | IHC3+ in 50% of cells or 2IHC2+/FISH+ (HER2:CEP17 ratio > 2 in > 50% of cells) |
- | - | - | - |
| MY PATHWAY
Meric-Bernstam (ongoing) |
II | Trastuzumab + pertuzumab | IHC/FISH HER2 amplification or mutation via NGS |
57 | 38 | - | - |
| MOUNTAINEER
Strickler ESMO 2019 |
II | Trastuzumab + tucatinib | IHC3+ or IHC2+ /FISH+ or NGS |
26 | 55 | 18.7 | |
| TRIUMPH
Nakamura ESMO 2019 |
II | Trastuzumab + pertuzumab | NGS selection on tissue and ctDNA |
19 | 35 | 4 | - |
| DESTINY-CRC01
(ongoing) |
II | Trastuzumab + deruxtecan (DS-8201) |
IHC/FISH Cohort A: IHC3+/IHC2+-FISH+ Cohort B: IHC2+ Cohort C: IHC1+ |
- | - | - | - |
FISH, fluorescent in situ hybridization; IHC, immunohistochemistry; mCRC, metastatic colorectal cancer mOS, median overall survival; mPFS, median progression free survival; NGS, next generation sequencing; ORR, overall response rate; T-DM1, trastuzumab emtansine.