Nonclinical precedent Request an invite

Padcev: animal efficacy model or human cells?

enfortumab vedotin · Nectin-4
Efficacy evidence
Nectin-4-expressing patient-derived bladder cancer xenografts (AG-B1, AG-B8) in mice: >75% tumor growth inhibition
“In vivo, enfortumab vedotin administration to AG-B1 and AG-B8 (cells expressing human Nectin-4) patient-derived human bladder cancer xenograft mouse models resulted in >75% tumor growth inhibition relative to the unconjugated antibody and the control (5% dextrose).”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
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: adequate in vitro and in vivo pharmacology in disease models, supporting clinical use
“An adequate program of in vitro and in vivo pharmacology was conducted in disease models for enfortumab vedotin, supporting the intended clinical use.”
✓ VerifiedEMA assessment report, p. 68Source ↗

Same question, other ADCs

Adcetris

brentuximab vedotin · CD30
Three xenograft models from human HL and ALCL cell lines

Besponsa

inotuzumab ozogamicin · CD22
Subcutaneous xenograft and systemically disseminated ALL mouse models

Datroway

datopotamab deruxtecan · Trop-2
Nude mouse xenografts of human pancreatic cancer, NSCLC and breast cancer

Decnupaz

pivekimab sunirine · CD123
Two BPDCN patient-derived xenograft (PDX) models in NSG mice

Elahere

mirvetuximab soravtansine · FRα
Ovarian cancer xenograft mouse models (single IV dose)

Emrelis

telisotuzumab vedotin · c-Met
c-Met-positive NSCLC cell line-derived and patient-derived xenograft mouse models

Enhertu

fam-trastuzumab deruxtecan · HER2
HER2-positive breast cancer xenograft mouse models (e.g., KPL-4 in nude mice)

Kadcyla

ado-trastuzumab emtansine · HER2
HER2+ xenografts (BT-474 EI, Calu-3) and MMTV-HER2 transgenic tumor model; growth inhibition in all three at 3 to 31 mg/kg

Mylotarg

gemtuzumab ozogamicin · CD33
CD33+ HL-60 leukemia xenograft in mice: >80% tumor growth inhibition

Polivy

polatuzumab vedotin · CD79b
Human DLBCL and B-cell lymphoma xenografts in mice; in vitro Ramos cytotoxicity

Tivdak

tisotumab vedotin · Tissue factor
Cervical cancer patient-derived xenograft (PDX) models in mice

Trodelvy

sacituzumab govitecan · Trop-2
Mouse xenografts bearing human Trop-2-expressing tumours

Zynlonta

loncastuximab tesirine · CD19
CD19-positive human Burkitt lymphoma (Ramos, Daudi) and DLBCL (WSU-DLCL2) xenografts in immunodeficient mice

Summary across all 14 ADCs →