Bizengri
zenocutuzumab · HER2 x HER3Mouse xenografts: HER2+ breast cancer (JIMT-1) and NRG1 fusion-positive lung and pancreatic patient-derived xenografts
Ordspono: animal efficacy model or human cells?
odronextamab · CD20 x CD3
Efficacy evidence
Lymphoma tumour models in humanized (BRG) mice and immunodeficient NSG mice
“The applicant has submitted 3 in vivo studies utilising two in vivo mouse models, consisting of humanized (BRG) mice and immunodeficient NSG mice, to evaluate antitumour activities of odronextamab in a repeat-dose setting.”
Why that model
No binding to rat or mouse CD3 or CD20
“Odronextamab was not able to bind to rat or mouse CD3 or CD20.”
Reviewer's view of the efficacy data
EMA: antitumour activity satisfactorily demonstrated in vivo; first two studies were prevention models (dosing at tumour implantation)
“Overall, the antitumour activity of odronextamab was satisfactorily demonstrated in the conducted in vivo studies. It can be noted that the first two studies are to be considered models of prevention since treatment with odronextamab was administered at the same time as tumour cells.”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD3Blinatumomab in NOD/SCID mouse tumor xenograft models
Columvi
glofitamab · CD20 x CD3Human HSC-engrafted NOG/NSG mice, non-tumor-bearing and tumor-bearing
Elrexfio
elranatamab · BCMA x CD3Multiple myeloma xenograft models (MM.1S, OPM2, MOLP8) with varying BCMA expression
Epkinly
epcoritamab · CD20 x CD3Human lymphoma cell line-derived xenograft (CDX) mouse models and one patient-derived xenograft (PDX) model
Hemlibra
emicizumab · FIXa x FXCynomolgus monkey models of acute and chronic hemophilia A
Imdelltra
tarlatamab · DLL3 x CD3Xenograft models in NSG mice injected with activated, expanded human T cells
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)Mice engrafted with HLA-A*02:01/gp100+ Mel526 human melanoma cells plus human PBMCs; tumor growth inhibition
Korjuny
catumaxomab · EpCAM x CD3SCID mouse i.p. human ovarian carcinoma ascites xenograft treated with human PBMCs plus catumaxomab
Lunsumio
mosunetuzumab · CD20 x CD3Human CD20/CD3 double-transgenic mice: peripheral and tissue B-cell depletion and T-cell activation (comparable to analogue 2H7v16/40G5c)
Lynozyfic
linvoseltamab · BCMA x CD3NSG mice co-implanted with human PBMC and NCI-H929 or MOLP-8 myeloma xenografts
Removab
catumaxomab · EpCAM x CD3Human ovarian carcinoma xenograft (catumaxomab); syngeneic human-EpCAM mouse tumour model with surrogate BiLu
Rybrevant
amivantamab · EGFR x METPatient-derived tumor xenografts with EGFR exon 20 insertion mutations in mice
Talvey
talquetamab · GPRC5D x CD3Myeloma cell line xenografts (H929 prophylactic; MM.1S, RPMI 8226 established) in humanized immunodeficient mice
Tecvayli
teclistamab · BCMA x CD3Human MM xenografts (H929, RPMI-8226) in human PBMC/T-cell-engrafted NSG mice
Vabysmo
faricimab · VEGF-A x Ang-2Laser-induced choroidal neovascularization (nAMD model) in cynomolgus monkeys, IVT faricimab vs ranibizumab
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)HER2 3+ xenografts in nude mice (SKOV-3, NCI-N87, patient-derived GXA 3054); no effect in HER2-negative model