TY - JOUR
T1 - Low leukemia burden improves blinatumomab efficacy in patients with relapsed/refractory B-cell acute lymphoblastic leukemia
AU - Queudeville, Manon
AU - Stein, Anthony S.
AU - Locatelli, Franco
AU - Ebinger, Martin
AU - Handgretinger, Rupert
AU - Gökbuget, Nicola
AU - Gore, Lia
AU - Zeng, Yi
AU - Gokani, Priya
AU - Zugmaier, Gerhard
AU - Kantarjian, Hagop M.
N1 - Funding Information:
Writing support was provided by Sukanya Raghuraman, PhD, of Cactus Life Sciences (part of Cactus Communications), which was supported by Amgen Inc. Statistical programming support was provided by Priti Kadu of IQVIA (RDS), Bengaluru, and Alex Zimmermann of Amgen Inc. (at the time of drafting this manuscript). This study was funded and supported by Amgen Inc.
Funding Information:
Manon Queudeville reports honoraria from Amgen Inc. Anthony Stein reports contractor fees from Amgen Inc. Franco Locatelli reports consulting and/or contractor fees from Amgen, Bellicum Pharmaceutical, Novimmune, Takeda, Medac, Neovii, Miltenyi, Gilead, Sobi, Inc, and Bluebird Bio, and membership on a board or advisory committee for Amgen Inc, Novartis, Pfizer, and Sanofi. Martin Ebinger reports honoraria from Amgen Inc and Jazz Pharmaceuticals and membership on a board or advisory committee with Amgen Inc. Nicola Gökbuget reports consulting fees (including expert testimony) from Amgen Inc, Autolus, Calgene, Jazz Pharmaceuticals, Pfizer, Novartis, and Gilead, research funding from Amgen Inc, Pfizer, Novartis, and Gilead, and membership on a board or advisory committee with Amgen Inc, Pfizer, Novartis, and Gilead. Lia Gore reports consultancy fees (including expert testimony) from Amgen Inc (uncompensated), Genentech/Roche (uncompensated), Novartis (uncompensated), Janssen (uncompensated), and Syndax (uncompensated), stock in Amgen Inc, Mirati, and Sanofi Paris, and membership on a board or advisory committee with OnKure, Janssen, and Kura. Yi Zeng reports stock in Amgen Inc. Priya Gokani reports stock in Amgen Inc. Gerhard Zugmaier reports stock in Amgen Inc and royalties from patent applications and/or patents WO2010/052014, WO2010/052013, WO2011/051307, WO2012/062596, and WO2015/181683. Hagop M. Kantarjian reports research funding from AbbVie, Amgen Inc, Ascentage Pharma Group, Bristol‐Myers Squibb, Daiichi Sankyo, Immunogen, Jazz, Novartis and honoraria from AbbVie, Amgen Inc, Ascentage Pharma Group, Astellas, AstraZeneca, Biologix, Curis, Ipsen Biopharmaceuticals, KAHR Medical, Novartis, Pfizer, Precision Biosciences, Shenzhen Target Rx, and Taiho Pharmaceutical Co., Ltd. The other author declares no conflicts of interest.
Funding Information:
Writing support was provided by Sukanya Raghuraman, PhD, of Cactus Life Sciences (part of Cactus Communications), which was supported by Amgen Inc. Statistical programming support was provided by Priti Kadu of IQVIA (RDS), Bengaluru, and Alex Zimmermann of Amgen Inc. (at the time of drafting this manuscript). This study was funded and supported by Amgen Inc.
Publisher Copyright:
© 2023 Amgen and The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.
PY - 2023/5/1
Y1 - 2023/5/1
N2 - Background: A lower baseline bone marrow blast percentage (bBMB%) is associated with better outcomes in patients with B-cell acute lymphoblastic leukemia (B-ALL) receiving blinatumomab. The objective of this analysis was to investigate the association between bBMB% and treatment outcomes in relapsed/refractory (R/R) B-ALL. Methods: Data from five trials of blinatumomab for R/R B-ALL were pooled for analyses. Patients were placed in one of three groups: group 1, ≥50% bBMBs; group 2, ≥25% to <50% bBMBs; group 3, ≥5% to <25% bBMBs. Response and survival outcomes were compared between groups. Results: Data from 683 patients (166 pediatric, 517 adult) were analyzed. Collectively, patients in groups 2 and 3 had significantly higher odds of achieving a complete remission (CR) (odds ratio [OR], 3.50 [95% confidence interval (CI), 2.23–5.48] and 3.93 [95% CI, 2.50–6.18], respectively; p <.001) and minimal/measurable residual disease response (OR, 2.61 and 3.37, respectively; p <.001) when compared with group 1 (reference). Groups 2 and 3 had a 37% and 46% reduction in the risk of death (hazard ratio [HR], 0.63 and 0.54, respectively; p <.001) and a 41% and 43% reduction in the risk of an event (relapse or death) (HR, 0.59 and 0.57, respectively; p <.001) compared with group 1. No significant differences in response or survival outcomes were observed between groups 2 and 3. Seven of nine patients whose bBMB% was lowered to <50% with dexamethasone achieved CR with blinatumomab. Conclusion: Any bBMB% <50% was associated with improved efficacy following blinatumomab treatment for R/R B-ALL.
AB - Background: A lower baseline bone marrow blast percentage (bBMB%) is associated with better outcomes in patients with B-cell acute lymphoblastic leukemia (B-ALL) receiving blinatumomab. The objective of this analysis was to investigate the association between bBMB% and treatment outcomes in relapsed/refractory (R/R) B-ALL. Methods: Data from five trials of blinatumomab for R/R B-ALL were pooled for analyses. Patients were placed in one of three groups: group 1, ≥50% bBMBs; group 2, ≥25% to <50% bBMBs; group 3, ≥5% to <25% bBMBs. Response and survival outcomes were compared between groups. Results: Data from 683 patients (166 pediatric, 517 adult) were analyzed. Collectively, patients in groups 2 and 3 had significantly higher odds of achieving a complete remission (CR) (odds ratio [OR], 3.50 [95% confidence interval (CI), 2.23–5.48] and 3.93 [95% CI, 2.50–6.18], respectively; p <.001) and minimal/measurable residual disease response (OR, 2.61 and 3.37, respectively; p <.001) when compared with group 1 (reference). Groups 2 and 3 had a 37% and 46% reduction in the risk of death (hazard ratio [HR], 0.63 and 0.54, respectively; p <.001) and a 41% and 43% reduction in the risk of an event (relapse or death) (HR, 0.59 and 0.57, respectively; p <.001) compared with group 1. No significant differences in response or survival outcomes were observed between groups 2 and 3. Seven of nine patients whose bBMB% was lowered to <50% with dexamethasone achieved CR with blinatumomab. Conclusion: Any bBMB% <50% was associated with improved efficacy following blinatumomab treatment for R/R B-ALL.
KW - acute lymphoblastic leukemia
KW - bispecific antibodies
KW - blinatumomab
KW - leukemia burden
KW - treatment efficacy
UR - http://www.scopus.com/inward/record.url?scp=85148748908&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85148748908&partnerID=8YFLogxK
U2 - 10.1002/cncr.34667
DO - 10.1002/cncr.34667
M3 - Article
C2 - 36829303
AN - SCOPUS:85148748908
SN - 0008-543X
VL - 129
SP - 1384
EP - 1393
JO - Cancer
JF - Cancer
IS - 9
ER -