Cervical cancer patient-derived xenograft (PDX) models in mice
“In vivo, anti-tumor activity and/or tumor regression was seen in cervical cancer patient derived xenograft (PDX) models when mice were administered tisotumab vedotin at 4 mg/kg twice in the first week of study via intravenous dosing.”
✓ VerifiedFDA multi-discipline review, p. 32Source ↗
Why that model
Tisotumab does not bind mouse, rat, rabbit, pig or dog TF
“Tisotumab did not bind to mouse, rat, rabbit, pig, or dog TF.”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗
Reviewer's view of the efficacy data
EMA: activity in 5 of 6 cervical PDX models; TF expression measured in only 1, so its influence is unclear
“For the cervical cancer PDX models, a positive effect of tisotumab vedotin was noted in 5 out of 6 models, primarily at dose of 2-4 mg/kg. It should be noted that TF expression was only determined for one out of six cervical cancer PDX models and it is therefore unclear how the level of TF expression has affected the results in these models.”