Activity of selected, novel anti-HER2 compounds under development

CompoundSponsorPhaseBC patients treatedORR in study armMedian PFS in study armNCT.gov
Monoclonal antibodies
Margetuximab (+ chemotherapy) [43]MacroGenicsIII53625%5.8 monthsNCT02492711
Antibody drug conjugates
Trastuzumab deruxtecan [47]Daiichi SankyoII18460.9%16.4 monthsNCT03248492
Trastuzumab duocarmazine [49]Byondis B.V.I4833%7.6 monthsNCT02277717
PF-06804103 [50]PfizerI1066%NANCT03284723
ARX788 [51]Ambrx, Inc.I4531%NANCT03255070
RC48-ADC [52]RemeGenI7031%5.8 monthsNCT03052634
A166 [53]Klus Pharma Inc.I2426%NANCT03602079
bsAbs
Zanidatamab (ZW25) [54]Zymeworks Inc.I1346%NANCT02892123
PRS-343 [55]Pieris Pharma, Inc.I1612%NANCT03330561
Zenocutuzumab (MCLA-128) (+ trastuzumab & vinorelbine) [56]Merus N.V.II2819%NANCT03321981
TKIs
Tucatinib (+ trastuzumab & capecitabine) [57]Seagen Inc.II R61240%7.8 monthsNCT02614794
Neratinib (+ capecitabine) [42]Puma Biotech. Inc.III R62133%5.6 monthsNCT01808573
Poziotinib (+ capecitabine) [58]Spectrum Pharma Inc.II10625%4 monthsNCT02659514
Pyrotinib (+ capecitabine) [59]Jiangsu HengRui Med. Co.II26767%12.5 monthsNCT03080805

R: randomized; NA: not applicable; PRS: progesterone receptors