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Inotuzumab ozogamicin in R/R B-ALL post-CD19 CAR T-cell therapy: A retrospective analysis

By Sheetal Bhurke

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Nov 28, 2025

Learning objective: After reading this article, learners will be able to cite a new clinical development in relapsed/refractory acute lymphocytic leukemia.


Results from a retrospective analysis investigating the efficacy and safety of inotuzumab ozogamicin (InO) in pediatric and young adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) (N = 9) post-CD19 chimeric antigen receptor (CAR) T-cell therapy were published by Ogrodnik et al. in Pediatric Blood & Cancer. Outcomes included overall response rate (ORR), measurable residual disease (MRD) negativity rates measured by flow cytometry, event-free survival (EFS), overall survival (OS), and adverse events (AEs).

Key data: The median survivor follow-up was 2.9 years with an ORR of 77.8% after one cycle of InO. Among responders, 66.7% of patients achieved MRD negativity. The 1-year EFS was 37.5%, and the 1-year OS was 50.0%, while the 2-year EFS and OS rates were 37.5% and 37.5%, respectively. Extramedullary disease (EMD) prior to InO and positive MRD after InO Cycle 1 were associated with poor outcomes. AEs included prolonged cytopenias, Grade 3 hepatotoxicity, and post-transplant sinusoidal obstructive syndrome.

Key learning: InO shows promise as a therapeutic option for pediatric patients with R/R B-ALL; however, the findings are limited by a small cohort.

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