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Table 2 Pharmacokinetics of pembrolizumab at steady state of regimens of 2 mg/kg Q3W, 200 mg Q3W, 10 mg/kg Q3W and 10 mg/kg Q2W. Based on pooled cross-study data [n, Mean (%CV), Median (10-90 percentile)]

From: Evaluation of dosing strategy for pembrolizumab for oncology indications

PK Value (unit)

Dose Regimen

N

Mean (%CV)

Median

10–90 Percentile

Cmax

(mcg/mL)

2 mg/kg Q3W

755

68.0 (24%)

66.3

48.3–88.2

200 mg Q3W

830

93.4 (26%)

89.1

66.4–124.3

10 mg/kg Q3W

1403

360.3 (23%)

357.6

257.7–466.8

10 mg/kg Q2W

652

459.3 (25%)

457.7

315.9–599.9

Ctrough

(mcg/mL)

2 mg/kg Q3W

755

22.2 (48%)

21.1

9.18–35.7

200 mg Q3W

830

29.7 (47%)

27.6

14.9–46.2

10 mg/kg Q3W

1403

126.4 (44%)

120.4

59.8–200.2

10 mg/kg Q2W

652

220.9 (39%)

217.8

111.8–325.3

AUCss, 0-6-weeks

(mcg*day/mL)

2 mg/kg Q3W

760

1376.5 (38%)

1316.5

724.9–2038.5

200 mg Q3W

830

1871.1 (37%)

1787.0

1120.6–2730.9

10 mg/kg Q3W

1405

7625.4 (35%)

7436.0

4354.0–11172.8

10 mg/kg Q2W

652

12002.7 (34%)

11993.5

6834.7–16895.5