N Engl J Med
ASH 2024: Blinatumomab improves survival in children with standard-risk B-cell ALL
Study design: This phase 3 trial involved children with newly diagnosed standard-risk B-cell acute lymphoblastic leukemia (B-cell ALL) at average or high risk of relapse. Patients were randomly assigned to receive either chemotherapy alone or chemotherapy plus two 28-day cycles of blinatumomab. Primary endpoint was disease-free survival.
Results: The data and safety monitoring committee reviewed the results from the first interim efficacy analysis, which included 1,440 patients who had undergone randomization (722 to chemotherapy alone and 718 to blinatumomab and chemotherapy), and recommended early termination of randomization. At a median follow-up of 2.5 years, the 3-year disease-free survival was 96.0% with blinatumomab and chemotherapy vs. 87.9% with chemotherapy alone. For patients with average relapse risk, the survival rates were 97.5% vs. 90.2%, and for high relapse risk, 94.1% vs. 84.8%. Grade 3 or higher cytokine release syndrome, seizures, and sepsis were rare, but nonfatal sepsis and catheter-related infections were more common in the blinatumomab group.
Impact on clinical practice: Adding blinatumomab to chemotherapy significantly improved disease-free survival in children with standard-risk B-cell ALL, particularly those at average or high risk of relapse. This finding supports the integration of blinatumomab into treatment protocols for this patient population.
Sources:
Gupta S, et al. (2024, December 7). N Engl J Med. Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children. https://pubmed.ncbi.nlm.nih.gov/39651791/
Rau, R., et al. (2024, December 8). Blinatumomab Added to Chemotherapy Improves Disease-Free Survival in Newly Diagnosed NCI Standard Risk Pediatric B-Acute Lymphoblastic Leukemia: Results from the Randomized Children’s Oncology Group Study AALL1731. Presented at American Society of Hematology Annual Meeting and Exposition. https://ash.confex.com/ash/2024/webprogram/Paper207450.html