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Atlas/Bispecific antibodies/Epkinly/Skipped studies

Epkinly: genotox, carcinogenicity and repro: done or skipped?

epcoritamab · CD20 x CD3
Check my plan vs. these
Genotoxicity
Not conducted (ICH S6(R1), ICH S9)
“Genotoxicity studies were not conducted for epcoritamab per ICHS6(R1) and ICH S9 guidance.”
✓ VerifiedFDA multi-discipline review, p. 57Source ↗
Carcinogenicity
Not conducted (ICH S6(R1), S1A, S9)
“Carcinogenicity studies were not conducted for epcoritamab per ICHS6(R1), ICH S1A, and ICH S9 guidance.”
✓ VerifiedFDA multi-discipline review, p. 57Source ↗
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.”
✓ VerifiedFDA multi-discipline review, p. 57Source ↗
Safety pharmacology
Incorporated into pivotal 5-week monkey study (CNS, respiratory, CV)
“No specific safety pharmacology studies have been conducted with epcoritamab.”
✓ VerifiedEMA assessment report, p. 30Source ↗

Same question, other bispecifics

Bizengri

zenocutuzumab · HER2 x HER3
Not conducted (ICH S6(R1))

Blincyto

blinatumomab · CD19 x CD3
Not conducted (ICH S6(R1); protein of natural amino acids)

Columvi

glofitamab · CD20 x CD3
Not conducted (ICH S6(R1))

Elrexfio

elranatamab · BCMA x CD3
Not conducted (ICH S6(R1))

Hemlibra

emicizumab · FIXa x FX
Not conducted (ICH S6)

Imdelltra

tarlatamab · DLL3 x CD3
Not conducted (ICH S6(R1))

Kimmtrak

tebentafusp · CD3 x gp100 (TCR fusion)
Not conducted (fusion protein; ICH S6/S9)

Korjuny

catumaxomab · EpCAM x CD3
Not conducted (ICH S6(R1))

Lunsumio

mosunetuzumab · CD20 x CD3
Not conducted (ICH S6(R1))

Lynozyfic

linvoseltamab · BCMA x CD3
Not conducted (antibody not expected to interact with DNA)

Ordspono

odronextamab · CD20 x CD3
Not conducted (antibody not expected to interact with DNA)

Removab

catumaxomab · EpCAM x CD3
Not conducted (not submitted; biologic, no relevant model)

Rybrevant

amivantamab · EGFR x MET
Not conducted (not appropriate for antibodies)

Talvey

talquetamab · GPRC5D x CD3
Not conducted (ICH S6; biotechnology-derived product)

Tecvayli

teclistamab · BCMA x CD3
Not conducted (ICH S6(R1))

Vabysmo

faricimab · VEGF-A x Ang-2
Not conducted (ICH S6(R1))

Ziihera

zanidatamab · HER2 x HER2 (biparatopic)
Not conducted (ICH S6(R1), ICH S9)

Summary across all 18 bispecifics →