TABLE 1.
Predicted and observed odronextamab exposure in patients with B‐cell non‐Hodgkin lymphoma
| Odronextamab dose in week 1 (mg) |
Predicted mean concentration (mg/L) a |
Observed mean (SD) concentration (mg/L) b | ||
|---|---|---|---|---|
| Cmax | Ctrough | Cmax | Ctrough | |
| 0.1 | 0.038 | 0.022 |
0.024 (0.020) (n = 7) |
0.0006 (0.0017) (n = 7) |
| 0.3 | 0.112 | 0.051 |
0.031 (0.037) (n = 7) |
0.0032 (0.0052) (n = 6) |
| 0.5 | 0.187 | 0.113 |
0.081 (0.046) (n = 5) |
0.0009 (0.0020) (n = 5) |
| 1 | 0.375 | 0.225 |
0.196 (0.024) (n = 79) |
0.0212 (0.0191) (n = 76) |
Abbreviations: Cmax, maximum concentration; Ctrough, trough concentration prior to the first dose of week 2; LLOQ, lower limit of quantification; SD, standard deviation.
a
Predicted exposures are based on a two‐compartment linear pharmacokinetic model using exposure data in cynomolgus monkeys. LLOQ in monkeys: 0.00313 mg/L.
b
Observed concentration data are based on the odronextamab first‐in‐human study. LLOQ in humans: 0.003 mg/L.