Table 3.

Summary statistics for PK parameters, Parts A and A-1

DosenCmax, μg/mL, geometric mean (CV%)Tmax, days, median (range)AUC0–28, μg·day/mL, geometric mean (CV%)AUC0–∞, μg·day/mL, geometric mean (CV%)t1/2,a days, geometric mean (CV%)
1 mg/kg416.4 (22)0.05 (0.02–0.17)158 (20)b212 (36)b14.1 (51)b
3 mg/kg3107 (26)0.17 (0.17–0.17)955 (23)1,530 (28)21.6 (10)
10 mg/kg10c256 (37)0.17 (0.03–0.99)2,150 (31)d3,270 (44)d17.7 (56)d

Abbreviations: AUC0-28, area under the concentration–time curve from day 0 up to day 28; AUC0–∞, area under the concentration–time curve from day 0 to infinity; Cmax, maximum observed serum concentration; CV, coefficient of variation; PK, pharmacokinetic; t1/2, elimination half-life; Tmax, time of maximum observed serum concentration.

  • aSampling up to 28 days following the first pembrolizumab administration.

  • bn = 3 (1 patient excluded because of treatment discontinuation).

  • cn = 3 from Part A and N = 7 from Part A-1.

  • dn = 9 (1 patient excluded because of treatment discontinuation).