Table 1.
Activity of selected, novel anti-HER2 compounds under development
| Compound | Sponsor | Phase | BC patients treated | ORR in study arm | Median PFS in study arm | NCT.gov |
|---|---|---|---|---|---|---|
| Monoclonal antibodies | ||||||
| Margetuximab (+ chemotherapy) [43] | MacroGenics | III | 536 | 25% | 5.8 months | NCT02492711 |
| Antibody drug conjugates | ||||||
| Trastuzumab deruxtecan [47] | Daiichi Sankyo | II | 184 | 60.9% | 16.4 months | NCT03248492 |
| Trastuzumab duocarmazine [49] | Byondis B.V. | I | 48 | 33% | 7.6 months | NCT02277717 |
| PF-06804103 [50] | Pfizer | I | 10 | 66% | NA | NCT03284723 |
| ARX788 [51] | Ambrx, Inc. | I | 45 | 31% | NA | NCT03255070 |
| RC48-ADC [52] | RemeGen | I | 70 | 31% | 5.8 months | NCT03052634 |
| A166 [53] | Klus Pharma Inc. | I | 24 | 26% | NA | NCT03602079 |
| bsAbs | ||||||
| Zanidatamab (ZW25) [54] | Zymeworks Inc. | I | 13 | 46% | NA | NCT02892123 |
| PRS-343 [55] | Pieris Pharma, Inc. | I | 16 | 12% | NA | NCT03330561 |
| Zenocutuzumab (MCLA-128) (+ trastuzumab & vinorelbine) [56] | Merus N.V. | II | 28 | 19% | NA | NCT03321981 |
| TKIs | ||||||
| Tucatinib (+ trastuzumab & capecitabine) [57] | Seagen Inc. | II R | 612 | 40% | 7.8 months | NCT02614794 |
| Neratinib (+ capecitabine) [42] | Puma Biotech. Inc. | III R | 621 | 33% | 5.6 months | NCT01808573 |
| Poziotinib (+ capecitabine) [58] | Spectrum Pharma Inc. | II | 106 | 25% | 4 months | NCT02659514 |
| Pyrotinib (+ capecitabine) [59] | Jiangsu HengRui Med. Co. | II | 267 | 67% | 12.5 months | NCT03080805 |
R: randomized; NA: not applicable; PRS: progesterone receptors