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