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.”