Adcetris
brentuximab vedotin · CD30Three xenograft models from human HL and ALCL cell lines
Emrelis: animal efficacy model or human cells?
telisotuzumab vedotin · c-Met
Efficacy evidence
c-Met-positive NSCLC cell line-derived and patient-derived xenograft mouse models
“In vivo, telisotuzumab vedotin exhibited antitumor activity in c-Met-positive NSCLC cell line-derived xenograft mouse models and an NSCLC patient-derived xenograft model.”
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
FDA agreed with the Applicant's pharmacology conclusions; objected only to promotional terms like 'potent'
“The Applicant uses terminology such as “potent” to describe results; such terms should be avoided as they are vague, subjective, and promotional. FDA agrees with the Applicant’s conclusions, with additional pertinent details below.”
Same question, other ADCs
Besponsa
inotuzumab ozogamicin · CD22Subcutaneous xenograft and systemically disseminated ALL mouse models
Datroway
datopotamab deruxtecan · Trop-2Nude mouse xenografts of human pancreatic cancer, NSCLC and breast cancer
Decnupaz
pivekimab sunirine · CD123Two BPDCN patient-derived xenograft (PDX) models in NSG mice
Elahere
mirvetuximab soravtansine · FRαOvarian cancer xenograft mouse models (single IV dose)
Enhertu
fam-trastuzumab deruxtecan · HER2HER2-positive breast cancer xenograft mouse models (e.g., KPL-4 in nude mice)
Kadcyla
ado-trastuzumab emtansine · HER2HER2+ 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 · CD33CD33+ HL-60 leukemia xenograft in mice: >80% tumor growth inhibition
Padcev
enfortumab vedotin · Nectin-4Nectin-4-expressing patient-derived bladder cancer xenografts (AG-B1, AG-B8) in mice: >75% tumor growth inhibition
Polivy
polatuzumab vedotin · CD79bHuman DLBCL and B-cell lymphoma xenografts in mice; in vitro Ramos cytotoxicity
Tivdak
tisotumab vedotin · Tissue factorCervical cancer patient-derived xenograft (PDX) models in mice
Trodelvy
sacituzumab govitecan · Trop-2Mouse xenografts bearing human Trop-2-expressing tumours
Zynlonta
loncastuximab tesirine · CD19CD19-positive human Burkitt lymphoma (Ramos, Daudi) and DLBCL (WSU-DLCL2) xenografts in immunodeficient mice