Population Pharmacokinetics of Inotuzumab Ozogamicin in Pediatric Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia: Results of Study ITCC-059

Table 5 Final model-based inotuzumab ozogamicin exposure simulation

Cumulative AUC simulation (median [IQR], 10³ ngh/mL)
	End of cycle 1	End of cycle 2	End of cycle 3
Adult BCP-ALL	19.7 [12.1–30.3]	79.0 [50.3–114]	155 [108–216]
Pediatric BCP-ALL	26.6 [17.9–37.0]	107 [78.8–139]	205 [154–262]
Difference (%, adult as reference)	+34.9	+35.9	+32.2

Cumulative AUC simulation (median, 10³ ngh/mL; without loading dose on day 1 cycle 1)
	End of cycle 1	Cumulative AUC difference (%; with loading dose and the adult/pediatric group as reference)
Adult BCP-ALL	17.9 [11.0–27.3]	−9.18%
Pediatric BCP-ALL	24.4 [16.6–33.2]	−8.28%

AUC area under the concentration–time curve, BCP-ALL B-cell precursor acute lymphoblastic leukemia, IQR interquartile range