Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Epkinly: genotox, carcinogenicity and repro: done or skipped?
epcoritamab · CD20 x CD3
Genotoxicity
Not conducted (ICH S6(R1), ICH S9)
“Genotoxicity studies were not conducted for epcoritamab per ICHS6(R1) and ICH S9 guidance.”
Carcinogenicity
Not conducted (ICH S6(R1), S1A, S9)
“Carcinogenicity studies were not conducted for epcoritamab per ICHS6(R1), ICH S1A, and ICH S9 guidance.”
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
Not conducted; EFD waived due to monkey immunogenicity; WOE assessment; no reproductive organ findings in 5-week study
“An EFD toxicity study of epcoritamab in cynomolgus monkeys was waived for phase 3 trials and registration of epcoritamab across ICH regions (FDA, EMEA, and PMDA) given the high potential for immunogenicity of epcoritamab in cynomolgus monkeys.”
Safety pharmacology
Incorporated into pivotal 5-week monkey study (CNS, respiratory, CV)
“No specific safety pharmacology studies have been conducted with epcoritamab.”
Genotox: Ames
Not conducted (ICH S6(R1), ICH S9)
“Genotoxicity studies were not conducted for epcoritamab per ICHS6(R1) and ICH S9 guidance.”
Genotox: in vitro mammalian
Not conducted (ICH S6(R1), ICH S9)
“Genotoxicity studies were not conducted for epcoritamab per ICHS6(R1) and ICH S9 guidance.”
Genotox: in vivo
Not conducted (ICH S6(R1), ICH S9)
“Genotoxicity studies were not conducted for epcoritamab per ICHS6(R1) and ICH S9 guidance.”
Carcinogenicity model
Not conducted (ICH S6(R1), S1A, S9)
“Carcinogenicity studies were not conducted for epcoritamab per ICHS6(R1), ICH S1A, and ICH S9 guidance.”
Carcinogenicity timing
Not required; FDA agreed carcinogenicity studies not needed for approval
“We agree that carcinogenicity studies are not needed to support the approval of BLA 761324.”
hERG / QT
No hERG assay; heart rate and RR, PR, QRS and QT intervals unaffected in monkey toxicity study
“Heart rate and RR, PR, QRS and QT intervals on Day 8 and 22 (repeated IV dosing) or Day 1 (single IV or SC dosing) were unaffected by treatment.”
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))
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)
Ordspono
odronextamab · CD20 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)