Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Ordspono: genotox, carcinogenicity and repro: done or skipped?
odronextamab · CD20 x CD3
Genotoxicity
Not conducted (antibody not expected to interact with DNA)
“Antibodies, such as odronextamab, are not expected to interact directly with DNA or other chromosomal material. Therefore, no genotoxicity studies were conducted with odronextamab.”
Carcinogenicity
Not conducted (ICH S9, advanced malignancy)
“As odronextamab is intended for use in patients with advanced malignancies, carcinogenicity studies were not conducted with odronextamab”
Instead of carcinogenicity
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Instead of genotoxicity
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
DRG histopathology
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Reproductive & developmental
No EFD study; fertility endpoints in 16-week monkey study unaffected; risk assessment in lieu (fetal B-cell lymphocytopenia, CRS)
“Embryo-fetal developmental toxicology studies with odronextamab were not conducted as such studies are expected to have limited value in further understanding and communicating risks to patients with advanced cancer.”
Safety pharmacology
Integrated into 4- and 16-week GLP monkey studies up to 1 mg/kg; no changes
“No changes on safety pharmacology endpoints were detected.”
Genotox: Ames
Not conducted (ICH S6/S2: antibody not expected to interact with DNA)
“Antibodies, such as odronextamab, are not expected to interact directly with DNA or other chromosomal material. Therefore, no genotoxicity studies were conducted with odronextamab.”
Genotox: in vitro mammalian
Not conducted (ICH S6/S2: antibody not expected to interact with DNA)
“Antibodies, such as odronextamab, are not expected to interact directly with DNA or other chromosomal material. Therefore, no genotoxicity studies were conducted with odronextamab.”
Genotox: in vivo
Not conducted (ICH S6/S2: antibody not expected to interact with DNA)
“Antibodies, such as odronextamab, are not expected to interact directly with DNA or other chromosomal material. Therefore, no genotoxicity studies were conducted with odronextamab.”
Carcinogenicity model
Not conducted (ICH S9, advanced malignancies)
“As odronextamab is intended for use in patients with advanced malignancies, carcinogenicity studies were not conducted with odronextamab, consistent with ICH guideline S9 on non-clinical evaluation for anticancer pharmaceuticals”
Carcinogenicity timing
Not required (ICH S9)
“As odronextamab is intended for use in patients with advanced malignancies, carcinogenicity studies were not conducted with odronextamab, consistent with ICH guideline S9 on non-clinical evaluation for anticancer pharmaceuticals”
hERG / QT
No hERG assay; no respiratory, neurological or cardiovascular changes in repeat-dose monkey studies
“There were no drug-related effects on vital signs (body temperature, blood pressure, and respiration and heart rate); or respiratory, neurological, or cardiovascular changes evident, nor infusion site reactions.”
Same question, other multispecifics
Blincyto
blinatumomab · CD19 x CD3Not conducted (ICH S6(R1); protein of natural amino acids)
Columvi
glofitamab · CD20 x CD3Not conducted (ICH S6(R1))
Elrexfio
elranatamab · BCMA x CD3Not conducted (ICH S6(R1))
Epkinly
epcoritamab · CD20 x CD3Not conducted (ICH S6(R1), ICH S9)
Hemlibra
emicizumab · FIXa x FXNot conducted (ICH S6)
Imdelltra
tarlatamab · DLL3 x CD3Not conducted (ICH S6(R1))
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)Not conducted (fusion protein; ICH S6/S9)
Korjuny
catumaxomab · EpCAM x CD3Not conducted (ICH S6(R1))
Lunsumio
mosunetuzumab · CD20 x CD3Not conducted (ICH S6(R1))
Lynozyfic
linvoseltamab · BCMA x CD3Not conducted (antibody not expected to interact with DNA)
Removab
catumaxomab · EpCAM x CD3Not conducted (not submitted; biologic, no relevant model)
Rybrevant
amivantamab · EGFR x METNot conducted (not appropriate for antibodies)
Talvey
talquetamab · GPRC5D x CD3Not conducted (ICH S6; biotechnology-derived product)
Tecvayli
teclistamab · BCMA x CD3Not conducted (ICH S6(R1))
Vabysmo
faricimab · VEGF-A x Ang-2Not conducted (ICH S6(R1))
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Not conducted (ICH S6(R1), ICH S9)