Table 5.
Impact of prior murine antibody exposure and antidrug development on omburtamab pharmacokinetics
No. of patients tested | CSF/blood ratio | t test | ||||
---|---|---|---|---|---|---|
Med | STDEV | Mean | SEM | |||
Dose 1 | ||||||
HAHA neg | 16 | 22.3 | 32.9 | 36.3 | 2.1 | 0.04* |
HAHA pos | 11 | 54.2 | 239.3 | 162.6 | 21.8 | |
No prior Ab | 17 | 19.8 | 22.9 | 25.5 | 1.4 | 0.02** |
Prior Ab | 14 | 55.9 | 213.1 | 144.6 | 15.2 | |
Dose 2 | ||||||
HAHA neg | 19 | 20.4 | 20.3 | 25.0 | 1.1 | 0.04* |
HAHA pos | 10 | 28.1 | 99.9 | 76.9 | 2.8 | |
No prior Ab | 15 | 14.9 | 15.0 | 19.9 | 1.0 | 0.05** |
Prior Ab | 14 | 33.7 | 85.5 | 65.4 | 2.4 |
Med median, STDEV standard deviation from the mean, SEM standard error of the mean, HAHA human antihuman antigen, Ab antibody
*t test comparing HAHA-negative vs HAHA-positive patients
**t test comparing patients with prior mAb exposure vs those without