Table 2.
Mean pharmacokinetic parameters for treatment groups of dostarlimab after single-dose intravenous infusion to monkeys
| Dose (mg/kg) | Sex | Cmax (μg/mL) | Tmax (h) | t1/2 (h) | AUC0–1320 (h × μg/mL) | Vss (mL/kg) | MRT (h) | CL (mL/h/kg) |
| 10 | Male | 265 ± 9.87 | 0.5 (0.5–1.0) | 31.0 (14.9–97.0) | 45,700 ± 21,800 | 39.9 ± 8.17 | 193 ± 129 | 0.248 ± 0.0933 |
| Female | 274 ± 6.81 | 0.5 (0.5–1.0) | 168.6 (72.1–282.6) | 57,400 ± 14,400 | 53.1 ± 5.28 | 314 ± 110 | 0.181 ± 0.0547 | |
| Combined | 269 ± 9.04 | 0.5 (0.5–1.0) | 84.5 (14.9–282.6) | 51,600 ± 17,700 | 46.5 ± 9.49 | 254 ± 126 | 0.215 ± 0.0778 | |
| 30 | Male | 758 ± 77.0 | 0.5 (0.5–1.0) | 58.5 (26.8–243.2) | 145,000 ± 34,100 | 48.5 ± 7.90 | 242 ± 99.0 | 0.213 ± 0.0465 |
| Female | 693 ± 44.7 | 0.5 (0.5–0.5) | 123.0 (86.7–217.2) | 189,000 ± 12,400 | 48.6 ± 6.81 | 307 ± 30.5 | 0.158 ± 0.00896 | |
| Combined | 725 ± 66.6 | 0.5 (0.5–1.0) | 104.9 (26.8–243.2) | 167,000 ± 33,200 | 48.5 ± 6.61 | 275 ± 74.5 | 0.186 ± 0.0424 | |
| 100 | Male | 3400 ± 80.0 | 1.0 (0.5–4.0) | 56.7 (31.1–138.7) | 426,000 ± 224,000 | 41.0 ± 39.4 | 282 ± 170 | 0.274 ± 0.114 |
| Female | 2930 ± 135 | 1.0 (0.5–1.0) | 60.7 (19.9–66.2) | 437,000 ± 126,000 | 47.5 ± 48.4 | 271 ± 213 | 0.242 ± 0.0685 | |
| Combined | 3170 ± 274 | 1.0 (0.5–4.0) | 58.7 (19.9–138.7) | 432,000 ± 163,000 | 43.9 ± 7.22 | 192 ± 79.9 | 0.258 ± 0.0863 |
Data are presented as mean ± standard deviation for Cmax, AUC0–1320, Vss, MRT, and CL values, and median (range) for Tmax and t1/2 values. AUC0–1320: area under the concentration–time curve from time 0 to 1320 hours; CL: clearance; Cmax: maximum concentration; MRT: mean residence time; t1/2: half-life; Tmax: time to Cmax; Vss: volume of distribution at steady state.