Adcetris
brentuximab vedotin · CD30Three xenograft models from human HL and ALCL cell lines
Decnupaz: animal efficacy model or human cells?
pivekimab sunirine · CD123
Efficacy evidence
Two BPDCN patient-derived xenograft (PDX) models in NSG mice
“In vivo activity was evaluated against two patient-derived xenograft (PDX) models of BPDCN using immunocompromised (NSG) mice and weekly intravenous injections beginning 24 hours after FcR blockade for three weeks.”
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: agrees with most of the primary pharmacology assessment, but ADCC activity is not negligible
“We agree with most of the Applicant’s assessment of the primary pharmacology studies, with some caveats. The Applicant’s position that immune effector cell activity is negligible, is contrary to the immune effector activity study (RD241447) that contained data showing comparable antibody-dependent cell-mediated cytotoxicity to the positive control, rituximab (detailed 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
Elahere
mirvetuximab soravtansine · FRαOvarian cancer xenograft mouse models (single IV dose)
Emrelis
telisotuzumab vedotin · c-Metc-Met-positive NSCLC cell line-derived and patient-derived xenograft mouse models
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