Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin

Talha Badar; Aniko Szabo; Martha Wadleigh; Michaela Liedtke; Shukaib Arslan; Caitlin Siebenaller; Ibrahim Aldoss; Elizabeth Schultz; Mehrdad Hefazi; Mark R. Litzow; Eric Kuo; Amy Wang; Emily Curran; Rory M. Shallis; Nikolai Podoltsev; Suresh Balasubramanian; Jay Yang; Ryan Mattison; Madelyn Burkart; Shira Dinner; Anjali Advani; Ehab Atallah

doi:10.1016/j.clml.2020.03.004

Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin

Talha Badar, Aniko Szabo, Martha Wadleigh, Michaela Liedtke, Shukaib Arslan, Caitlin Siebenaller, Ibrahim Aldoss, Elizabeth Schultz, Mehrdad Hefazi, Mark R. Litzow, Eric Kuo, Amy Wang, Emily Curran, Rory M. Shallis, Nikolai Podoltsev, Suresh Balasubramanian, Jay Yang, Ryan Mattison, Madelyn Burkart, Shira DinnerAnjali Advani, Ehab Atallah^*

^*Corresponding author for this work

Medicine, Hematology Oncology Division

Research output: Contribution to journal › Article › peer-review

14 Scopus citations

Abstract

Background: Inotuzumab ozogamicin (InO) is an anti-CD22 monoclonal antibody–drug (calicheamicin) conjugate that has shown superior efficacy compared to conventional chemotherapy in relapsed/refractory (RR) B-cell acute lymphocytic leukemia (ALL) patients. We sought to find the safety and efficacy of InO in a real-world setting. Patients and Methods: A multicenter cohort analysis on 84 RR ALL patients who received InO outside of clinical trials was conducted to evaluate response and toxicity. Results: The median (range) age of patients at InO initiation was 50 (20-87) years. Forty patients (48%) had ≥ 3 therapies and 23 patients (27%) underwent allogeneic hematopoietic stem-cell transplantation (allo-HCT) before InO. The median (range) number of cycles of InO provided was 2 (1-6), and cumulative dose was 3.3 (1.8-9.3) mg/m². Overall response rate (complete remission/complete remission with incomplete count recovery) was 63%; 44% had complete remission with minimal residual disease negativity. Twenty-three patients (27%) with response received allo-HCT. The median duration of response was 11.5 months and when censored at allo-HCT was not reached (51% in remission at 2 years). The median overall survival after InO was 11.6 months and when censored at time of allo-HCT was 13.6 months. The most common grade 3 or higher adverse events observed were transaminitis (16%), hyperbilirubinemia (5%), bleeding (4%), veno-occlusive disease (2%), and hyperglycemia (2%). In multivariate analysis, allo-HCT after InO did not retain favorable significance for duration of response (hazard ratio = 1.27; 95% confidence interval, 0.89-1.61; P =.2) or overall survival (hazard ratio = 1.10; 95% confidence interval, 0.37-3.25; P =.85). Conclusion: InO was well tolerated and had significant efficacy in RR B-cell ALL patients.

Original language	English (US)
Pages (from-to)	556-560.e2
Journal	Clinical Lymphoma, Myeloma and Leukemia
Volume	20
Issue number	8
DOIs	https://doi.org/10.1016/j.clml.2020.03.004
State	Published - Aug 2020

Funding

N.P. consulted for and received honoraria from Alexion, Pfizer, Agios Pharmaceuticals, Blueprint Medicines, Incyte, Novartis, Celgene, Bristol-Myers Squib, and CTI biopharma. N.A.P. received research funding (all to the institution) from Boehringer Ingelheim, Astellas Pharma, Daiichi Sankyo, Sunesis Pharmaceuticals, Jazz Pharmaceuticals, Pfizer, Astex Pharmaceuticals, CTI Biopharma, Celgene, Genentech, AI Therapeutics, Samus Therapeutics, Arog Pharmaceuticals, and Kartos Therapeutics. A.A. reports receiving honoraria and/or serving as a consultant for Glycomimetics, KiTE Pharmaceuticals, Novartis, and Pfizer; and receiving research support from Amgen, AbbVie, Macrogenics, Glycomimetics, and Pfizer. R.J.M. has served on the advisory board for Pfizer. The other authors have stated that they have no conflict of interest.

Keywords

Allogeneic HCT
B-cell ALL
Ph-positive ALL
RR ALL
VOD

ASJC Scopus subject areas

Hematology
Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.clml.2020.03.004

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Badar, T., Szabo, A., Wadleigh, M., Liedtke, M., Arslan, S., Siebenaller, C., Aldoss, I., Schultz, E., Hefazi, M., Litzow, M. R., Kuo, E., Wang, A., Curran, E., Shallis, R. M., Podoltsev, N., Balasubramanian, S., Yang, J., Mattison, R., Burkart, M., ... Atallah, E. (2020). Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin. Clinical Lymphoma, Myeloma and Leukemia, 20(8), 556-560.e2. https://doi.org/10.1016/j.clml.2020.03.004

@article{872bf35e376549b98724486cd6cdf751,

title = "Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin",

abstract = "Background: Inotuzumab ozogamicin (InO) is an anti-CD22 monoclonal antibody–drug (calicheamicin) conjugate that has shown superior efficacy compared to conventional chemotherapy in relapsed/refractory (RR) B-cell acute lymphocytic leukemia (ALL) patients. We sought to find the safety and efficacy of InO in a real-world setting. Patients and Methods: A multicenter cohort analysis on 84 RR ALL patients who received InO outside of clinical trials was conducted to evaluate response and toxicity. Results: The median (range) age of patients at InO initiation was 50 (20-87) years. Forty patients (48%) had ≥ 3 therapies and 23 patients (27%) underwent allogeneic hematopoietic stem-cell transplantation (allo-HCT) before InO. The median (range) number of cycles of InO provided was 2 (1-6), and cumulative dose was 3.3 (1.8-9.3) mg/m2. Overall response rate (complete remission/complete remission with incomplete count recovery) was 63%; 44% had complete remission with minimal residual disease negativity. Twenty-three patients (27%) with response received allo-HCT. The median duration of response was 11.5 months and when censored at allo-HCT was not reached (51% in remission at 2 years). The median overall survival after InO was 11.6 months and when censored at time of allo-HCT was 13.6 months. The most common grade 3 or higher adverse events observed were transaminitis (16%), hyperbilirubinemia (5%), bleeding (4%), veno-occlusive disease (2%), and hyperglycemia (2%). In multivariate analysis, allo-HCT after InO did not retain favorable significance for duration of response (hazard ratio = 1.27; 95% confidence interval, 0.89-1.61; P =.2) or overall survival (hazard ratio = 1.10; 95% confidence interval, 0.37-3.25; P =.85). Conclusion: InO was well tolerated and had significant efficacy in RR B-cell ALL patients.",

keywords = "Allogeneic HCT, B-cell ALL, Ph-positive ALL, RR ALL, VOD",

author = "Talha Badar and Aniko Szabo and Martha Wadleigh and Michaela Liedtke and Shukaib Arslan and Caitlin Siebenaller and Ibrahim Aldoss and Elizabeth Schultz and Mehrdad Hefazi and Litzow, {Mark R.} and Eric Kuo and Amy Wang and Emily Curran and Shallis, {Rory M.} and Nikolai Podoltsev and Suresh Balasubramanian and Jay Yang and Ryan Mattison and Madelyn Burkart and Shira Dinner and Anjali Advani and Ehab Atallah",

note = "Publisher Copyright: {\textcopyright} 2020 Elsevier Inc.",

year = "2020",

month = aug,

doi = "10.1016/j.clml.2020.03.004",

language = "English (US)",

volume = "20",

pages = "556--560.e2",

journal = "Clinical Lymphoma, Myeloma and Leukemia",

issn = "2152-2650",

publisher = "Cancer Media Group",

number = "8",

}

Badar, T, Szabo, A, Wadleigh, M, Liedtke, M, Arslan, S, Siebenaller, C, Aldoss, I, Schultz, E, Hefazi, M, Litzow, MR, Kuo, E, Wang, A, Curran, E, Shallis, RM, Podoltsev, N, Balasubramanian, S, Yang, J, Mattison, R, Burkart, M, Dinner, S, Advani, A & Atallah, E 2020, 'Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin', Clinical Lymphoma, Myeloma and Leukemia, vol. 20, no. 8, pp. 556-560.e2. https://doi.org/10.1016/j.clml.2020.03.004

TY - JOUR

T1 - Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin

AU - Badar, Talha

AU - Szabo, Aniko

AU - Wadleigh, Martha

AU - Liedtke, Michaela

AU - Arslan, Shukaib

AU - Siebenaller, Caitlin

AU - Aldoss, Ibrahim

AU - Schultz, Elizabeth

AU - Hefazi, Mehrdad

AU - Litzow, Mark R.

AU - Kuo, Eric

AU - Wang, Amy

AU - Curran, Emily

AU - Shallis, Rory M.

AU - Podoltsev, Nikolai

AU - Balasubramanian, Suresh

AU - Yang, Jay

AU - Mattison, Ryan

AU - Burkart, Madelyn

AU - Dinner, Shira

AU - Advani, Anjali

AU - Atallah, Ehab

PY - 2020/8

Y1 - 2020/8

N2 - Background: Inotuzumab ozogamicin (InO) is an anti-CD22 monoclonal antibody–drug (calicheamicin) conjugate that has shown superior efficacy compared to conventional chemotherapy in relapsed/refractory (RR) B-cell acute lymphocytic leukemia (ALL) patients. We sought to find the safety and efficacy of InO in a real-world setting. Patients and Methods: A multicenter cohort analysis on 84 RR ALL patients who received InO outside of clinical trials was conducted to evaluate response and toxicity. Results: The median (range) age of patients at InO initiation was 50 (20-87) years. Forty patients (48%) had ≥ 3 therapies and 23 patients (27%) underwent allogeneic hematopoietic stem-cell transplantation (allo-HCT) before InO. The median (range) number of cycles of InO provided was 2 (1-6), and cumulative dose was 3.3 (1.8-9.3) mg/m2. Overall response rate (complete remission/complete remission with incomplete count recovery) was 63%; 44% had complete remission with minimal residual disease negativity. Twenty-three patients (27%) with response received allo-HCT. The median duration of response was 11.5 months and when censored at allo-HCT was not reached (51% in remission at 2 years). The median overall survival after InO was 11.6 months and when censored at time of allo-HCT was 13.6 months. The most common grade 3 or higher adverse events observed were transaminitis (16%), hyperbilirubinemia (5%), bleeding (4%), veno-occlusive disease (2%), and hyperglycemia (2%). In multivariate analysis, allo-HCT after InO did not retain favorable significance for duration of response (hazard ratio = 1.27; 95% confidence interval, 0.89-1.61; P =.2) or overall survival (hazard ratio = 1.10; 95% confidence interval, 0.37-3.25; P =.85). Conclusion: InO was well tolerated and had significant efficacy in RR B-cell ALL patients.

AB - Background: Inotuzumab ozogamicin (InO) is an anti-CD22 monoclonal antibody–drug (calicheamicin) conjugate that has shown superior efficacy compared to conventional chemotherapy in relapsed/refractory (RR) B-cell acute lymphocytic leukemia (ALL) patients. We sought to find the safety and efficacy of InO in a real-world setting. Patients and Methods: A multicenter cohort analysis on 84 RR ALL patients who received InO outside of clinical trials was conducted to evaluate response and toxicity. Results: The median (range) age of patients at InO initiation was 50 (20-87) years. Forty patients (48%) had ≥ 3 therapies and 23 patients (27%) underwent allogeneic hematopoietic stem-cell transplantation (allo-HCT) before InO. The median (range) number of cycles of InO provided was 2 (1-6), and cumulative dose was 3.3 (1.8-9.3) mg/m2. Overall response rate (complete remission/complete remission with incomplete count recovery) was 63%; 44% had complete remission with minimal residual disease negativity. Twenty-three patients (27%) with response received allo-HCT. The median duration of response was 11.5 months and when censored at allo-HCT was not reached (51% in remission at 2 years). The median overall survival after InO was 11.6 months and when censored at time of allo-HCT was 13.6 months. The most common grade 3 or higher adverse events observed were transaminitis (16%), hyperbilirubinemia (5%), bleeding (4%), veno-occlusive disease (2%), and hyperglycemia (2%). In multivariate analysis, allo-HCT after InO did not retain favorable significance for duration of response (hazard ratio = 1.27; 95% confidence interval, 0.89-1.61; P =.2) or overall survival (hazard ratio = 1.10; 95% confidence interval, 0.37-3.25; P =.85). Conclusion: InO was well tolerated and had significant efficacy in RR B-cell ALL patients.

KW - Allogeneic HCT

KW - B-cell ALL

KW - Ph-positive ALL

KW - RR ALL

KW - VOD

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U2 - 10.1016/j.clml.2020.03.004

DO - 10.1016/j.clml.2020.03.004

M3 - Article

C2 - 32291234

AN - SCOPUS:85083004098

SN - 2152-2650

VL - 20

SP - 556-560.e2

JO - Clinical Lymphoma, Myeloma and Leukemia

JF - Clinical Lymphoma, Myeloma and Leukemia

IS - 8

ER -

Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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