Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study by Daniel J. DeAngelo, Wendy.

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Presentation transcript:

Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study by Daniel J. DeAngelo, Wendy Stock, Anthony S. Stein, Andrei Shustov, Michaela Liedtke, Charles A. Schiffer, Erik Vandendries, Katherine Liau, Revathi Ananthakrishnan, Joseph Boni, A. Douglas Laird, Luke Fostvedt, Hagop M. Kantarjian, and Anjali S. Advani BloodAdv Volume 1(15):1167-1180 June 27, 2017 © 2017 by The American Society of Hematology

Daniel J. DeAngelo et al. Blood Adv 2017;1:1167-1180 © 2017 by The American Society of Hematology

Kaplan-Meier distributions. Kaplan-Meier distributions. (A) DOR. (B) PFS. (C) OS. See supplemental Materials for DOR, PFS, and OS definitions. PR, partial response. Daniel J. DeAngelo et al. Blood Adv 2017;1:1167-1180 © 2017 by The American Society of Hematology

Peripheral blood B-lymphocyte depletion and regeneration. Peripheral blood B-lymphocyte depletion and regeneration. (A) B-lymphocyte concentration in blood was determined vs time for individual patients during InO treatment (red circles; n = 72) and during follow-up (triangles; n = 24). Data were fitted to a linear mixed-effects model (green dashed lines = individual model predictions; solid black line = best fit line for overall mean effect of time on B-lymphocyte depletion and regeneration). (B) B-lymphocyte concentration profiles vs time by InO dose (1.2, 1.6, and 1.8 mg/m2 per cycle) for individual patients. (C) InO elimination vs time by percent of BM blasts for individual patients. The 4 panels show serum InO concentration vs time data for InO dosing at cycle 1 day 1 and 15 and cycle 2 days 1 and 15. BM aspirates were collected at screening (circles), cycle 1 day 28 (triangles), and cycle 2 day 28 (squares). Symbol colors are scaled by percent leukemic blasts in BM. Daniel J. DeAngelo et al. Blood Adv 2017;1:1167-1180 © 2017 by The American Society of Hematology

Relationship between InO PK parameters and MRD status. Relationship between InO PK parameters and MRD status. (A) Box plots of dose normalized (dn) values of median Cmax and Cmin by cycle (1 to 4) and by achievement of MRD negativity (yes vs no). Boxes correspond to the 25% and 75% percentiles; whiskers extend to the most extreme data point that is no more than 1.5 times the length of the box away from the box. Red points represent potential outliers and correspond to individual values >1.5 times the interquartile range above or below the respective quartile. (B) Relationship between percentage BM blasts at baseline and achieving MRD negativity for individual patients. Green and blue plots correspond to patients achieving and not achieving MRD negativity, respectively. (C) The 5 panels show serum InO concentration vs time by MRD-negativity status for dosing at cycle 1 day 1 and 15, cycle 2 days 1 and 15, and cycle 4 day 1. Symbol sizes represent percent leukemic blasts in BM. Daniel J. DeAngelo et al. Blood Adv 2017;1:1167-1180 © 2017 by The American Society of Hematology