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Elrexfio: animal efficacy model or human cells?

elranatamab · BCMA x CD3
Efficacy evidence
Multiple myeloma xenograft models (MM.1S, OPM2, MOLP8) with varying BCMA expression
“The anti-tumor activity of elranatamab was evaluated in MM xenograft models (with MM.1S, OPM2, and MOLP8 cell lines) that had varying levels of BCMA expression.”
✓ VerifiedFDA multi-discipline review, p. 52Source ↗
Why that model
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.
Reviewer's view of the efficacy data
EMA: in vivo xenograft studies provide sufficient proof-of-concept for use in multiple myeloma
“These in vivo studies provide sufficient proof-of-concept for the use of elranatamab in treatment of Multiple Myeloma.”
✓ VerifiedEMA assessment report, p. 45Source ↗

Same question, other bispecifics

Bizengri

zenocutuzumab · HER2 x HER3
Mouse xenografts: HER2+ breast cancer (JIMT-1) and NRG1 fusion-positive lung and pancreatic patient-derived xenografts

Blincyto

blinatumomab · CD19 x CD3
Blinatumomab in NOD/SCID mouse tumor xenograft models

Columvi

glofitamab · CD20 x CD3
Human HSC-engrafted NOG/NSG mice, non-tumor-bearing and tumor-bearing

Epkinly

epcoritamab · CD20 x CD3
Human lymphoma cell line-derived xenograft (CDX) mouse models and one patient-derived xenograft (PDX) model

Hemlibra

emicizumab · FIXa x FX
Cynomolgus monkey models of acute and chronic hemophilia A

Imdelltra

tarlatamab · DLL3 x CD3
Xenograft 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 CD3
SCID mouse i.p. human ovarian carcinoma ascites xenograft treated with human PBMCs plus catumaxomab

Lunsumio

mosunetuzumab · CD20 x CD3
Human CD20/CD3 double-transgenic mice: peripheral and tissue B-cell depletion and T-cell activation (comparable to analogue 2H7v16/40G5c)

Lynozyfic

linvoseltamab · BCMA x CD3
NSG mice co-implanted with human PBMC and NCI-H929 or MOLP-8 myeloma xenografts

Ordspono

odronextamab · CD20 x CD3
Lymphoma tumour models in humanized (BRG) mice and immunodeficient NSG mice

Removab

catumaxomab · EpCAM x CD3
Human ovarian carcinoma xenograft (catumaxomab); syngeneic human-EpCAM mouse tumour model with surrogate BiLu

Rybrevant

amivantamab · EGFR x MET
Patient-derived tumor xenografts with EGFR exon 20 insertion mutations in mice

Talvey

talquetamab · GPRC5D x CD3
Myeloma cell line xenografts (H929 prophylactic; MM.1S, RPMI 8226 established) in humanized immunodeficient mice

Tecvayli

teclistamab · BCMA x CD3
Human MM xenografts (H929, RPMI-8226) in human PBMC/T-cell-engrafted NSG mice

Vabysmo

faricimab · VEGF-A x Ang-2
Laser-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

Summary across all 18 bispecifics →