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2024-10-23T11:04:09.000Z

Inotuzumab ozogamicin in combination with dexamethasone as induction for older patients with B-ALL: Results from the INITIAL-1 study

Oct 23, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in acute lymphoblastic leukemia.

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Despite advancements in treatment strategies for older patients with ALL (>55 years), the current SoC strategies continue to be associated with high rates of early mortality, significant toxicities, and poor prognosis. Results of the phase II INITIAL-1 (NCT03460522) trial, which evaluated the efficacy and safety of InO combined with dexamethasone as a frontline induction therapy for older patients with Ph− B-ALL, were published in the Journal of Clinical Oncology by Stelljes et al.1

Key learnings
100% of evaluable patients (n = 43) experienced a CR or CRi after two cycles of InO combined with dexamethasone.
MRD assessment revealed a molecular CR in 71% of patients after a third cycle of treatment.
After a median follow-up of 2.7 years, the 1- and 3-year EFS rates were 88% and 55%, respectively, with 1- and 3-year OS rates of 91% and 73%.
The most frequent Grade ≥3 AEs during induction therapy included leukocytopenia in 74%, neutropenia in 56%, thrombocytopenia in 49%, and anemia in 37%.
Throughout the 3-year follow-up period, the cumulative incidence of relapse was 27%.
These data demonstrate the feasibility of InO as a novel induction strategy in Ph− ALL, offering an alternative to traditional induction therapies for older patients who may not be able to tolerate intensive chemotherapy.
InO can be administered in the community, reducing the need for hospitalization and therefore preserving quality of life.
There is a need for further trials to establish optimal dosing regimens and to evaluate alternative combinations to further improve patient outcomes.


Abbreviations: AE, adverse event; ALL, acute lymphoblastic leukemia; B-ALL, B-cell ALL; CR, complete response; CRi, complete response with incomplete hematologic recovery; EFS, event-free survival; InO, inotuzumab ozogamicin; MRD, measurable residual disease; OS, overall survival; Ph−, Philadelphia chromosome-negative; SoC, standard of care. 

This educational resource is independently supported by Pfizer. All content is developed by SES in collaboration with an expert steering committee; funders are allowed no influence on the content of this resource.

  1. Stelljes M, Raffel S, Alakel N, et al. Inotuzumab ozogamicin as induction therapy for patients older than 55 years with Philadelphia chromosome-negative B-precursor ALL. J Clin Oncol. 2024;42(3):273-282. DOI: 1200/JCO.23.00546

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