THURSDAY, Dec. 12, 2024 (HealthDay News) — For patients with newly diagnosed, standard-risk B-cell acute lymphoblastic leukemia (ALL) with an average or high risk for relapse, adding blinatumomab to combination chemotherapy is associated with improved disease-free survival, according to a study published online Dec. 7 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego.
Sumit Gupta, Ph.D., from the University of Toronto, and colleagues conducted a phase 3 trial involving children with newly diagnosed standard-risk B-cell ALL who had an average or high risk for relapse. A total of 1,440 patients were randomly assigned to receive chemotherapy alone or chemotherapy plus blinatumomab; the results from the first interim efficacy analysis, which included 722 and 718 patients, respectively, were reviewed.
The researchers found that the estimated three-year disease-free survival was 96.0 ± 1.2 percent with blinatumomab and chemotherapy and 87.9 ± 2.1 percent with chemotherapy alone at a median follow-up of 2.5 years (difference in restricted mean survival time, 72 days). Among patients with an average relapse risk, the estimated three-year disease-free survival was 97.5 ± 1.3 percent with blinatumomab and chemotherapy and 90.2 ± 2.3 percent with chemotherapy alone; the corresponding values were 94.1 ± 2.5 percent and 84.8 ± 3.8 percent, respectively, among those with a high relapse risk.
“The addition of blinatumomab to standard chemotherapy resulted in a significant improvement in disease-free survival,” the authors write. “This improvement was consistent across subgroups defined according to patient-related or disease-related characteristics.”
Several authors disclosed ties to pharmaceutical companies, including Amgen, which manufactures blinatumomab and contributed funding for the study.
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