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Blinatumomab (Blina), a bispecific T-cell engager, was approved by the U.S. Food and Drug Administration and European Commission as part of consolidation therapy for the treatment of adult patients with newly diagnosed Ph− (also known as BCR::ABL1-negative) CD19+ B-ALL, based on results from the ECOG-ACRIN E1910 trial (NCT02003222), previously reported on the ALL Hub.1 ECOG-ACRIN E1910 is a randomized, multicenter, phase III trial assessing the safety and efficacy of Blina + consolidation chemotherapy (chemo) vs chemo alone in patients with newly diagnosed Ph− B-ALL in MRD-negative remission.1 A subgroup analysis from this trial evaluating outcomes of Blina + consolidation chemo vs chemo alone in patients aged <55 years was presented by Dinner at the 2025 EHA Annual Meeting.2 The analysis included 277 patients aged 30–54 years with MRD-negative (<0.01%) BCR::ABL1-negative B-ALL; subgroups included patients aged 30–39 years, patients with BCR::ABL1-like B-ALL, and patients with BMI ≥30. The primary objective of the analysis was to compare OS and RFS between treatment arms.2
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Key learnings |
In patients aged 30–54 years, 3-year OS and RFS were significantly higher with Blina + chemo vs chemo alone; 92% vs 67% (p < 0.001) and 86% vs 66% (p = 0.009), respectively. |
3-year OS and RFS were higher with Blina + chemo vs chemo alone in patients aged 30–39 years (100% vs 73% and 90% vs 69%, respectively) and in the BCR::ABL1-like subgroup (OS and RFS: both 100% vs 45%). BMI did not impact outcomes. |
Grade 3–4 TRAEs in the Blina + chemo vs chemo alone included neutrophil count decrease (80% vs 89%), platelet count decrease (59% vs 70%), neurologic disorders (38% vs 11%), anemia (31% vs 37%), infection (20% vs 12%), and sepsis (8% vs 6%). |
These data demonstrate the efficacy of Blina + chemo in consolidation for adults aged 30–54 years, despite around half of patients having high-risk disease, supporting the use of Blina + chemo as consolidation for younger adults with MRD-negative B-ALL. |
B-ALL, B-cell lineage acute lymphoblastic leukemia; Blina, blinatumomab; BMI, body mass index; chemo, chemotherapy; MRD, measurable residual disease; Ph−, Philadelphia chromosome-negative; OS, overall survival; RFS, relapse-free survival; TRAE, treatment-related adverse event.
References
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