Children's National Medical Center, Washington, DC
Anne L. Angiolillo , Reuven J. Schore , Gregory H. Reaman , Naomi Joan Winick , Meenakshi Devidas , Hao W. Zheng , Charlotte Wood , Ashley R. Lane , Elizabeth A. Raetz , William L. Carroll , Stephen Hunger
Pegaspargase 2500 IU/m2 (n=43) |
EZN-2285 2500 IU/m2 (n=40) |
EZN-2285 2100 IU/m2 (n=62) |
|
---|---|---|---|
Cmax (mIU/mL) | 1,647±474 | 1,655±366 | 1,291±379 |
t½ (hrs) | 127±51 | 322±118 | 305±98 |
AUC0-25d (mIU*hr/mL) | 359,781±80,309 | 470,742±123,584 | 369,998±122,013 |
AUC0-inf (mIU*hr/mL) | 387,015±85,753 | 574,091±158,574 | 454,394±144,348 |
Asparaginase activity (mIU/mL) 25 D post drug |
72.8±47.9 | 339.6±126.8 | 271.6±118.2 |
Asparaginase activity ≥100/≥400 mIU/mL 25 D post drug (%) |
67/0 | 98/28 | 94/14 |
Plasma asparagine depletion 25/42 D post drug (%) |
88/8 | 92/72.4 | 93/75 |
Safety population | (n=54) | (n=42) | (n=69) |
Allergy (%) | 7 | 2 | 1 |
Coagulopathy (%) | 0 | 7 | 3 |
Hyperbilirubinemia (%) | 7 | 12 | 9 |
Hyperglycemia (%) | 15 | 26 | 35 |
Hyperlipidemia (%) | 6 | 5 | 1 |
Pancreatitis (%) | 4 | 5 | 6 |
Thrombosis (%) | 0 | 0 | 6 |
CNS (%) | 0 | 0 | 1 |
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