HER2-positive breast cancer xenograft mouse models (e.g., KPL-4 in nude mice)
“The anti-tumor activity of DS-8201a was evaluated in several mouse models of breast cancer. In a mouse xenograft model of HER2-positive breast cancer, the activity of a single dose of 10 mg/kg DS-8201a or MAAL-9001 was evaluated 13 days after inoculation of KPL-4 cells to female CAnN.Cg-Foxn1nu/CrlCrlj nude mice”
✓ VerifiedFDA multi-discipline review, p. 45Source ↗
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
CHMP: PDX data suggest efficacy incl. T-DM1-refractory tumours, but lower effect than lower-DAR comparator in one model was unexpected
“Results in patient-derived xenograft (PDX) models of breast cancer suggest that DS-8201a is effective even in T-DM1 refractory HER2-expressing breast cancer tumours due to the drug-linker system with a different mechanism of action. However, it is unexpected that DS-8201a has a clear, although not significant, lesser effect than MAAL-9002b which has a two times lower drug-to-antibody ratio (DAR) in the HER2-positive CTG-0708 model.”