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Mylotarg: animal efficacy model or human cells?

gemtuzumab ozogamicin · CD33
Efficacy evidence
CD33+ HL-60 leukemia xenograft in mice: >80% tumor growth inhibition
“In vivo antitumor effects of CMA-676 were studied in an HL-60 xenograft tumor model. CMA-676 showed a dose-response effect with >80% inhibition of tumor growth at doses between 0.8 and 2.4 mg/m2 NAc-gamma calicheamicin DMH equivalents”
✓ VerifiedFDA pharmacology/toxicology review, p. 13Source ↗
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
Xenograft doses far exceeded clinical doses, partly because subcutaneous HL-60 grows as a solid tumor
“were much higher than the doses used in clinical trials (0.25 to 9 mg protein/m2 ) at least in part because the subcutaneously implanted HL-60 leukemia grows as a solid tumor.”
✓ VerifiedFDA pharmacology/toxicology review, p. 13Source ↗

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

Padcev

enfortumab vedotin · Nectin-4
Nectin-4-expressing patient-derived bladder cancer xenografts (AG-B1, AG-B8) in mice: >75% 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 →