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Elahere: animal efficacy model or human cells?

mirvetuximab soravtansine · FRα
Efficacy evidence
Ovarian cancer xenograft mouse models (single IV dose)
“In vivo, mirvetuximab soravtansine delayed tumor growth and caused tumor regression in several ovarian cancer xenograft mouse models when mice were administered a single IV dose of mirvetuximab soravtansine containing antibody doses as low as 1.2 mg/kg and DM4 dose of 25 µg/kg.”
✓ VerifiedFDA multi-discipline review, p. 37Source ↗
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: pharmacology data generally adequate and in line with guidelines
“The pharmacology data is considered in general adequate; the development program is in line with the regulatory guidelines.”
✓ VerifiedEMA assessment report, p. 60Source ↗

Same question, other ADCs

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

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Nectin-4-expressing patient-derived bladder cancer xenografts (AG-B1, AG-B8) in mice: >75% tumor growth inhibition

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Human DLBCL and B-cell lymphoma xenografts in mice; in vitro Ramos cytotoxicity

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

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

Summary across all 14 ADCs →