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

Research output: Contribution to journalArticle

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 languageEnglish (US)
Pages (from-to)556-560.e2
JournalClinical Lymphoma, Myeloma and Leukemia
Volume20
Issue number8
DOIs
StatePublished - Aug 2020

Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Fingerprint Dive into the research topics of 'Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin'. Together they form a unique fingerprint.

  • Cite this

    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