Characterizing the ideal patient for treatment with inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: A systematic literature review Review


Authors: Marks, D. I.; Cassaday, R. D.; Ribera, J. M.; Schuh, A. C.; Park, J. H.; Chiaretti, S.; Stelljes, M.
Review Title: Characterizing the ideal patient for treatment with inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: A systematic literature review
Abstract: Introduction: Inotuzumab ozogamicin (InO) is indicated for the treatment of adults with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL). This systematic literature review (CRD42022330496) assessed outcomes by baseline characteristics for patients with R/R ALL treated with InO to identify which patients may benefit most. Methods: In adherence with PRISMA guidelines, searches were run in Embase and MEDLINE. Inclusion criteria were real-world evidence, observational studies, and phase 2–4 trials. The Cochrane Risk of Bias tool and Newcastle-Ottawa instrument assessed quality. Results: 34 publications were included; 11 described the phase 3 INO-VATE trial. Patients treated with InO who were CD22-positive, in first salvage, and eligible for subsequent hematopoietic stem cell transplant (HSCT) had improved outcomes. Reduced incidence of veno-occlusive disease was observed in patients with normal transaminase levels and bilirubin, no prior liver disease, and who did not receive dual alkylators. Conclusions: The ideal patient for InO treatment has CD22-positive disease (≥20% leukemic blasts), normal liver function, no history of liver disease, is in first salvage, has not previously received HSCT, prefers outpatient treatment, or has high disease burden. Limitations included potentially missing publications that were non-English, not identified in the searches, or available after the date the searches were conducted. Registration: This systematic review was registered on the Prospective Register of Systematic Reviews (PROSPERO), registration number: CRD42022330496. © 2025 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
Keywords: cancer chemotherapy; cancer survival; treatment outcome; review; salvage therapy; drug efficacy; drug safety; patient selection; cancer patient; outcome assessment; antineoplastic agent; incidence; recurrence; cytogenetics; hematopoietic stem cell transplantation; drug resistance; drug resistance, neoplasm; acute lymphoblastic leukemia; age; bilirubin; immunotherapy; recurrent disease; precursor cell lymphoblastic leukemia-lymphoma; aminotransferase; drug therapy; tyrosine kinase inhibitor; leukemia relapse; outpatient care; therapy; cd22 antigen; blast cell; phase 2 clinical trial (topic); phase 3 clinical trial (topic); liver venoocclusive disease; inotuzumab ozogamicin; relapsed/refractory; procedures; cancer prognosis; phase 4 clinical trial (topic); blinatumomab; disease burden; humans; human; b cell acute lymphoblastic leukemia; immunological antineoplastic agent; antineoplastic agents, immunological; chimeric antigen receptor t-cell immunotherapy; vod/sos; newcastle-ottawa scale; preferred reporting items for systematic reviews and meta-analyses; veno-occlusive disease/sinusoidal obstruction syndrome; cd22 protein, human; sialic acid binding ig-like lectin 2
Journal Title: Expert Review of Hematology
Volume: 18
Issue: 1
ISSN: 1747-4086
Publisher: Taylor & Francis Group  
Date Published: 2025-01-01
Start Page: 91
End Page: 103
Language: English
DOI: 10.1080/17474086.2025.2450223
PUBMED: 39778191
PROVIDER: scopus
DOI/URL:
Notes: Review -- Source: Scopus
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  1. Jae Hong Park
    356 Park