TY - JOUR
T1 - Prognostic implications of cytogenetics in adults with acute lymphoblastic leukemia treated with inotuzumab ozogamicin
AU - Jabbour, Elias
AU - Advani, Anjali S.
AU - Stelljes, Matthias
AU - Stock, Wendy
AU - Liedtke, Michaela
AU - Gökbuget, Nicola
AU - Martinelli, Giovanni
AU - O'Brien, Susan
AU - White, Jane Liang
AU - Wang, Tao
AU - Luisa Paccagnella, M.
AU - Sleight, Barbara
AU - Vandendries, Erik
AU - DeAngelo, Daniel J.
AU - Kantarjian, Hagop M.
N1 - Funding Information:
Pfizer, Grant/Award Number: This study was sponsored by Pfizer Inc.
Funding Information:
EJ has received research grants and consulting honoraria from Pfizer Inc. ASA has received honoraria from Pfizer Inc. and research support from Amgen. MS has received research grants and consulting honoraria from Pfizer Inc. WS has received research support from Sigma-Tau and honoraria from ADC Therapeutics, Amgen, Gilead, and Sigma-Tau. ML has received research support and honoraria from Pfizer Inc. and Amgen. NG has received research support and honoraria from Pfizer Inc. and Amgen outside the submitted work. GM has consulted for and been on speakers' bureaus for ARIAD, Celgene, Pfizer Inc., Roche, Bristol-Myers Squibb, and Novartis outside the submitted work. SO has received research support and honoraria from Pfizer Inc. JLW, TW, MLP, BS, and EV are employees of and own stock in Pfizer Inc. DJD has received honoraria from Pfizer Inc., Amgen, Celgene, Takeda, Shire, and Incyte. HMK has received research grants from Pfizer Inc. and Amgen.
Funding Information:
information Pfizer, Grant/Award Number: This study was sponsored by Pfizer Inc.This study was sponsored by Pfizer Inc. Associate Professor Cheng Cameron Yin (Department of Hematopathology, MD Anderson Cancer Center, Houston, Texas) assisted with the review and interpretation of cytogenetic data. Editorial support, funded by Pfizer Inc., was provided by Anny Wu, PharmD, of Complete Healthcare Communications, LLC and Chu Kong Liew, PhD, of Engage Scientific Solutions.
Publisher Copyright:
© 2019 Wiley Periodicals, Inc.
PY - 2019/4
Y1 - 2019/4
N2 - Karyotype is frequently used to predict response and outcome in leukemia. This post hoc exploratory analysis evaluated the relationship between baseline cytogenetics and outcome in patients with relapsed/refractory acute lymphoblastic leukemia (R/R ALL) treated with inotuzumab ozogamicin (InO), a humanized CD22 antibody conjugated to calicheamicin, in the phase 3, open-label, randomized INO-VATE trial. Data as of March 8, 2016, are presented in this analysis. Of the 326 patients randomized, 284 had screening karyotyping data (144 in the InO arm and 140 in the standard care [SC] arm). With InO, complete remission or complete remission with incomplete hematologic recovery (CR/CRi), minimal residual disease negativity rates, and overall survival (OS) were not significantly different between cytogenetic subgroups. CR/CRi rates favored InO over SC in the diploid with ≥20 metaphases, complex, and “other” cytogenetic subgroups. The OS hazard ratio favored InO over SC in the diploid with ≥20 metaphases, complex, and other cytogenetic subgroups. Generally, InO is effective and provides substantial clinical benefit in patients with R/R ALL who have specific baseline karyotypes.
AB - Karyotype is frequently used to predict response and outcome in leukemia. This post hoc exploratory analysis evaluated the relationship between baseline cytogenetics and outcome in patients with relapsed/refractory acute lymphoblastic leukemia (R/R ALL) treated with inotuzumab ozogamicin (InO), a humanized CD22 antibody conjugated to calicheamicin, in the phase 3, open-label, randomized INO-VATE trial. Data as of March 8, 2016, are presented in this analysis. Of the 326 patients randomized, 284 had screening karyotyping data (144 in the InO arm and 140 in the standard care [SC] arm). With InO, complete remission or complete remission with incomplete hematologic recovery (CR/CRi), minimal residual disease negativity rates, and overall survival (OS) were not significantly different between cytogenetic subgroups. CR/CRi rates favored InO over SC in the diploid with ≥20 metaphases, complex, and “other” cytogenetic subgroups. The OS hazard ratio favored InO over SC in the diploid with ≥20 metaphases, complex, and other cytogenetic subgroups. Generally, InO is effective and provides substantial clinical benefit in patients with R/R ALL who have specific baseline karyotypes.
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U2 - 10.1002/ajh.25394
DO - 10.1002/ajh.25394
M3 - Article
C2 - 30623490
AN - SCOPUS:85060251849
SN - 0361-8609
VL - 94
SP - 408
EP - 416
JO - American journal of hematology
JF - American journal of hematology
IS - 4
ER -