Table 5.
Isatuximab plasma pharmacokinetic parameters at cycle 1 of phase 1
| Phase 1 | ||
|---|---|---|
| 10 mg/kg QW/Q2W (n = 3) | 20 mg/kg QW/Q2W (n = 5) | |
| Patients with evaluable PK, n | 3 | 4 |
| Infusion duration, h | ||
| Median (range) | 2.63 (2.32‐3.23) | 3.82 (3.28‐6.05) a |
| Ceoi, µg/mL | ||
| Mean (SD) | 122 (21.6) | 246 (51.8) |
| Geometric mean (CV%) | 121 (18) | 242 (21) |
| Cmax, µg/mL | ||
| Mean (SD) | 124 (22.9) | 280 (64.4) |
| Geometric mean (CV%) | 123 (18) | 274 (23) |
| AUC1week, (μg•hr/mL) | ||
| Mean (SD) | 9300 (3010) | 21 300 (5520) |
| Geometric mean (CV%) | 8970 (32) | 20 800 (26) |
| tmax, h | ||
| Median (range) | 2.68 (2.32‐7.25) | 5.56 (3.28‐8.48) |
Abbreviations: AUC1week, area under the plasma concentration versus time in the 1‐week dosing interval; Ceoi, concentration at the end of infusion; Cmax, maximum concentration; CV, coefficient of variation; PK, pharmacokinetic; Q2W, every 2 weeks; QW, every week; tmax, time to reach Cmax.
a
n = 5.