Table 2

Summary statistics of pharmacokinetic parameters of enoblituzumab after 2-hour intravenous infusion doses of 3–15 mg/kg weekly

ParameterUnitStatisticWeekly enoblituzumab dose
3 mg/kg10 mg/kg15 mg/kg
First dose, C1/D1
Cmaxµg/mLGM (%CV) (n)84 (34) (5)238 (14) (2)420 (40) (99)
tmaxhourMedian (min–max) (n)3 (2–5) (5)2.5 (2–3) (2)3 (2–48) (99)
 AUCτµg·hour/mLGM (%CV) (n)6254 (35) (4)21 918 (15) (2)36 889 (36) (90)
 AUC0–infµg·hour/mLGM (%CV) (n)10 321 (46) (4)36 941 (10) (2)64 111 (39) (88)
 CLmL/hour/kgMean (SD) (n)0.314 (0.156) (4)0.271 (0.028) (2)0.250 (0.087) (88)
VssmL/kgMean (SD) (n)51.9 (14.1) (4)49.7 (8.8) (2)46.9 (15.2) (88)
t1/2hourMean (SD) (n)128.2 (21.2) (4)130.7 (9.1) (2)141.7 (45.6) (88)
Multiple dose, C2/D1
Cmaxµg/mLGM (%CV) (n)167 (28) (4)797 (26) (62)
tmaxhourMedian (min–max) (n)3 (2–8) (4)3 (2–24) (62)
 AUCτµg·hour/mLGM (%CV) (n)19 981 (40) (4)93 590 (31) (51)
 CLmL/hour/kgMean (SD) (n)0.160 (0.072) (4)0.168 (0.054) (51)
VssmL/kgMean (SD) (n)59.1 (11.9) (4)62.1 (21.9) (46)
t1/2hourMean (SD) (n)283.7 (95.1) (4)275.6 (124.9) (46)
 AI AUCτGM (%CV) (n)3.20 (9) (4)2.48 (48) (48)
  • AI, accumulation index; AUC0–inf, area under the serum concentration–time curve from time zero extrapolated to infinity; AUCτ, area under the concentration–time curve over the dosing interval; C, cycle; CL, clearance; Cmax, maximum observed serum concentration; CV, coefficient of variation; D, dose; GM, geometric mean; t1/2, half-life; tmax, time of maximum concentration; Vss, volume of distribution at steady state.