Pharmacokinetics in patients with CSCC following intravenous administration of cemiplimab
| Group, dose | Observed cemiplimab concentrations at steady state (weeks 17–19) | |||||
| Ctrough, mg/L | Cmax, mg/L | |||||
| n | Mean (SD) | Median (IQR) | n | Mean (SD) | Median (IQR) | |
| Groups 1 and 2, 3 mg/kg Q2W | 96 | 68.4 (26.1) | 72.0 (49.9–80.8) | 96 | 150 (79.0) | 141 (113–162) |
| Group 3, 350 mg Q3W | 34 | 62.7 (28.3) | 65.3 (44.3–77.3) | 33 | 151 (46.2) | 165 (129–181) |
| Group 4, 600 mg Q4W | 44 | 62.5 (24.1) | 65.4 (50.7–80.4) | 41 | 281 (235) | 239 (205–268) |
| Cemiplimab dose | Predicted cemiplimab concentrations at steady state using population PK model (n=1062) | |||||
| Ctrough, mg/L | Cmax, mg/L | Cav, mg/mL | ||||
| Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | |
| 350 mg Q3W | 60.8 (27.4) | 56.6 (42.4–74.1) | 173 (47.3) | 168 (139–198) | 92.9 (33.0) | 88.4 (70.1–111) |
| 600 mg Q4W | 68.4 (33.2) | 63.2 (45.9–84.4) | 260 (69.1) | 254 (211–297) | 119 (42.5) | 114 (90.1–143) |
Data cut-off date: 20 April 2020.
Cav, average concentration; Cmax, maximum concentration; CSCC, cutaneous squamous cell carcinoma; Ctrough, trough concentration; PK, pharmacokinetics; Q2W, every 2 weeks; Q3W, every 3 weeks; Q4W, every 4 weeks.