Table 3.
Isatuximab (plasma) | |||
---|---|---|---|
5 mg/kg QW/Q2W | 10 mg/kg QW/Q2W | 20 mg/kg QW/Q2W | |
Cycle 1 | |||
n | 5 | 18 | 6 |
Cmax, mean ± SD (geometric mean) [CV%], µg/mL | 91.3 ± 19.8 (89.7) [21.7] | 141 ± 18.8 (140) [13.3] | 297 ± 16.7 (296) [5.6] |
tmax, median (min-max), h | 2.42 (2.13-3.83) | 3.41 (2.30-28.00) | 5.22 (4.28-8.93) |
AUC1week, mean ± SD (geometric mean) [CV%], μg·h/mL | 6100 ± 2840 (5580) [46.5] | 12 800 ± 2430* (12 600) [18.9] | 27 000 ± 5620 (26 500) [20.8] |
Cycle 3 | |||
n | 6 | 24 | 6 |
Cmax, mean ± SD (geometric mean) [CV%], µg/mL | 167 ± 34.5 (164) [20.6] | 403 ± 163 (375) [40.4] | 648 ± 246 (611) [38.0] |
tmax, median (min-max), h | 5.97 (1.83-7.25) | 6.36 (2.00-23.67) | 7.52 (4.25-48.17) |
AUC2weeks, mean ± SD (geometric mean) [CV%], μg·h/mL | 30 900 ± 10 900 (29 000) [35.2] | 71 000 ± 34 600† (63 990) [48.7] | 156 000 ± 91 000‡ (134 000) [58.5] |
Cmax, peak serum concentration; SD, standard deviation; tmax, time when peak serum concentration is reached. See Table 1 for expansion of other abbreviations.
n = 16.
n = 19.
n = 5.