Bizengri
zenocutuzumab · HER2 x HER313 weeks
Elrexfio: how long were the pivotal tox studies?
elranatamab · BCMA x CD3
Longest pivotal study
13 weeks
“In the 3-month repeat-dose SC toxicity study, elranatamab doses of 0.3, 3, and 6 mg/kg/week (total of 14 doses) showed adverse clinical signs that correlated with decreased body weight and food consumption and contributed to mortality.”
Pivotal GLP studies
GLP cynomolgus: 1-month IV (0.01-0.3 mg/kg/wk), 1-month SC (0.3 mg/kg/wk), 3-month SC (0.3, 3, 6 mg/kg/wk); no recovery
“Recovery was not assessed in any of the general toxicology studies.”
Route in tox
IV and SC (SC is clinical route, used for longest study)
“Intravenous administration was originally assessed before subcutaneous administration was chosen as the clinical route.”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD313 weeks
Columvi
glofitamab · CD20 x CD34 weeks
Epkinly
epcoritamab · CD20 x CD35 weeks
Hemlibra
emicizumab · FIXa x FX26 weeks
Imdelltra
tarlatamab · DLL3 x CD313 weeks
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)0 (no in vivo tox study)
Korjuny
catumaxomab · EpCAM x CD30 (no in vivo tox study)
Lunsumio
mosunetuzumab · CD20 x CD326 weeks
Lynozyfic
linvoseltamab · BCMA x CD314 weeks
Ordspono
odronextamab · CD20 x CD316 weeks
Removab
catumaxomab · EpCAM x CD30 (no in vivo tox study)
Rybrevant
amivantamab · EGFR x MET13 weeks
Talvey
talquetamab · GPRC5D x CD34 weeks
Tecvayli
teclistamab · BCMA x CD35 weeks
Vabysmo
faricimab · VEGF-A x Ang-226 weeks
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)13 weeks