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Single agent subcutaneous blinatumomab for advanced acute lymphoblastic leukemia.
- Source :
-
American journal of hematology [Am J Hematol] 2024 Apr; Vol. 99 (4), pp. 586-595. Date of Electronic Publication: 2024 Feb 05. - Publication Year :
- 2024
-
Abstract
- Blinatumomab is a BiTE® (bispecific T-cell engager) molecule that redirects CD3 <superscript>+</superscript> T-cells to engage and lyse CD19 <superscript>+</superscript> target cells. Here we demonstrate that subcutaneous (SC) blinatumomab can provide high efficacy and greater convenience of administration. In the expansion phase of a multi-institutional phase 1b trial (ClinicalTrials.gov, NCT04521231), heavily pretreated adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) received SC blinatumomab at two doses: (1) 250 μg once daily (QD) for week 1 and 500 μg three times weekly (TIW) thereafter (250 μg/500 μg) or (2) 500 μg QD for week 1 and 1000 μg TIW thereafter (500 μg/1000 μg). The primary endpoint was complete remission/complete remission with partial hematologic recovery (CR/CRh) within two cycles. At the data cutoff of September 15, 2023, 29 patients were treated: 14 at the 250 μg/500 μg dose and 13 at 500 μg/1000 μg dose. Data from two ineligible patients were excluded. At the end of two cycles, 12 of 14 patients (85.7%) from the 250 μg/500 μg dose achieved CR/CRh of which nine patients (75.0%) were negative for measurable residual disease (MRD; <10 <superscript>-4</superscript> leukemic blasts). At the 500 μg/1000 μg dose, 12 of 13 patients (92.3%) achieved CR/CRh; all 12 patients (100.0%) were MRD-negative. No treatment-related grade 4 cytokine release syndrome (CRS) or neurologic events (NEs) were reported. SC injections were well tolerated and all treatment-related grade 3 CRS and NEs responded to standard-of-care management, interruption, or discontinuation. Treatment with SC blinatumomab resulted in high efficacy, with high MRD-negativity rates and acceptable safety profile in heavily pretreated adults with R/R B-ALL.<br /> (© 2024 The Authors. American Journal of Hematology published by Wiley Periodicals LLC.)
- Subjects :
- Adult
Humans
Remission Induction
Pathologic Complete Response
Acute Disease
Neoplasm, Residual
Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy
Antibodies, Bispecific adverse effects
Lymphoma, B-Cell drug therapy
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma drug therapy
Antineoplastic Agents adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1096-8652
- Volume :
- 99
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- American journal of hematology
- Publication Type :
- Academic Journal
- Accession number :
- 38317420
- Full Text :
- https://doi.org/10.1002/ajh.27227