The work is published in the NEJM, one of the best scientific journals. The quality of the work is very good. The study is a multicenter study of major European pediatric cancer centers. The outcomes of patients with blinatumomomab are compared with their same cohort of patients treated with the same chemotherapy [without immunotherapy]. 

Blinatumomomab is an antibody used in adults with acute lymphoblastic leukemia (ALL) after refractory relapse. In the pediatric population there are several trials in early phases to test dose, safety and efficacy. In infants there are also studies that demonstrate that it is a safe drug. 

This study compares survival when adding a cycle of blinatumomab to conventional chemotherapy with good results. Among the limitations are that the comparison is with a retrospective cohort and that the number of patients is not particularly large. 

ALL in the infant is rare. Of patients under one year of age with ALL, 80% have KMT2A gene rearrangement. Patients with this rearrangement have a worse prognosis than those without. 

They are patients with a lot of toxicity from treatment, many infections and mortality associated with chemotherapy complications, added to the fact that they have a higher relapse rate than pediatric patients older than one year with ALL. These relapses are early (during the treatment itself or in the first year or two after treatment). 

The use of blinatumomab is safe and effective in improving infant survival. 

The data in this article are important in the design of the upcoming INTERFANT 21 protocol [phase 3 trial], which will use blinatumomab in the treatment of these infants in combination with chemotherapy.

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