In a randomized phase 3 trial in children with newly diagnosed high-risk B-cell ALL, the replacement of two cycles of highly toxic conventional chemotherapy with two cycles of blinatumomab resulted in a significant improvement in the four-year EFS rates. These findings suggest the possibility to reducing the chemotherapy length and intensity by integrating immunotherapy upfront in the management of B-ALL. — Elias Jabbour, MD
Replacing two cycles of conventional chemotherapy with blinatumomab significantly improved four-year event-free survival (EFS) in children with newly diagnosed high-risk B-cell acute lymphoblastic leukemia (B-ALL), according to a randomized phase 3 study published in the New England Journal of Medicine.
The study’s authors, led by Marin Schrappe, MD, of Christian Albrechts University Kiel and University Hospital Schleswig-Holstein in Germany, enrolled pediatric patients with high-risk B-ALL to receive two cycles of either blinatumomab or control chemotherapy after consolidation therapy. The primary end point was EFS based on a time-to-event analysis.
Overall, the trial randomized 358 patients to blinatumomab and 351 to control chemotherapy The interim analysis after a median follow-up of 2.9 years showed the four-year EFS was 83% (95% CI, 77.4-87.4) with blinatumomab compared with 70.3% (95% CI, 63.8-75.9) with chemotherapy (hazard ratio, 0.51; 95% CI, 0.35-0.73; P=.0002).
Treatment-related infections occurred in 23.9% of the blinatumomab group and 69.4% of the chemotherapy group (P<.001). Life-threatening adverse events occurred in two patients in the blinatumomab group, including one fatal event, and 16 patients in the chemotherapy group. Neurotoxicity occurred in 12% of the blinatumomab group and 3.2% of the chemotherapy group. Grade 2 or higher cytokine release syndrome occurred in 1.1% of patients in the blinatumomab group.
“Blinatumomab, an anti-CD19 bispecific T-cell engager, may offer a safe replacement for traditional chemotherapy in pediatric patients with newly diagnosed high-risk B-ALL,” Dr. Schrappe and colleagues wrote.
Reference
Schrappe M, Locatelli F, Valsecchi MG, et al; AIEOP-BFM ALL 2017 Consortium. N Engl J Med. 2026;395(11):1075-1089. doi:10.1056/NEJMoa2604166
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