Bizengri
zenocutuzumab · HER2 x HER313 weeks
Rybrevant: how long were the pivotal tox studies?
amivantamab · EGFR x MET
Longest pivotal study
13 weeks
“Janssen conducted a GLP-compliant 13-week toxicology study in cynomolgus monkeys. Monkeys received intravenous amivantamab once weekly at doses of 0, 60, or 120 mg/kg.”
Pivotal GLP studies
Cynomolgus IV weekly: 4-week non-GLP tolerability, 6-week GLP (6-week recovery), 13-week GLP; 2-week SC local tolerance
“The repeat-dose toxicity of amivantamab in cynomolgus monkeys was evaluated in a 4-week tolerability non-GLP study, and 6-week toxicity with 6-week recovery and 13-week toxicity GLP studies.”
Route in tox
Intravenous (slow bolus, weekly); SC for local tolerance
“Route of administration: Intravenous; slow bolus injection”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD313 weeks
Columvi
glofitamab · CD20 x CD34 weeks
Elrexfio
elranatamab · BCMA x CD313 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)
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