Blinatumomab improves event-free survival in children with high-risk B-cell ALL

22 Sep 2026, 22:00 · Medical Xpress

by Elana Gotkine

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Blinatumomab is associated with significantly higher event-free survival among children with newly diagnosed high-risk B-cell acute lymphoblastic leukemia (ALL), according to a study published in the Sept. 17 issue of the New England Journal of Medicine.

Dr. Martin Schrappe, of Christian Albrechts University Kiel in Germany, and colleagues randomly assigned children with newly diagnosed high-risk B-cell ALL to receive two cycles of blinatumomab (blinatumomab group) or two cycles of chemotherapy (control group) after consolidation (358 and 351 children, respectively).

The researchers found that estimated four-year event-free survival was 83.0% and 70.3% in the blinatumomab and control groups, respectively, at a planned interim analysis with a median follow-up of 2.9 years. For a primary end-point event, the estimated hazard ratio was 0.51 for blinatumomab versus control. Overall, 23.9% and 69.4% of patients in the blinatumomab and control groups, respectively, had infection related to the trial treatment. Life-threatening adverse events occurred in 0.5% and 4.7% of patients in the blinatumomab and control groups, respectively, including one (in 0.3%) that was fatal in the blinatumomab group.

"The excellent outcomes observed in the current trial beg the question of whether integration of blinatumomab obviates the need for transplantation in some or all these high-risk patients," Dr. Regina M. Myers and Dr. Stephen P. Hunger, of Children's Hospital of Philadelphia, write in an accompanying editorial.

Publication details

Martin Schrappe et al, Blinatumomab for Replacing Chemotherapy in Pediatric Acute Lymphoblastic Leukemia, New England Journal of Medicine (2026). DOI: 10.1056/nejmoa2604166

Regina M. Myers et al, Blinatumomab — A New Standard of Care in Acute Lymphoblastic Leukemia, New England Journal of Medicine (2026). DOI: 10.1056/nejme2610500

Journal information: New England Journal of Medicine

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