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Improved disease-free survival with blinatumomab plus chemotherapy in pediatric higher-risk B-ALL: AALL1731 study
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The phase III randomized AALL1731 (NCT03914625) study evaluated the efficacy and safety of two cycles of blinatumomab (15 mg/m2/day for 28 days) plus chemotherapy in children (aged 1 to <10 years) with newly diagnosed SR B-ALL, subcategorized based on risk of relapse to SR-high (n = 301) or SR-average (n = 417). Results were presented at the 66th American Society of Hematology Annual Meeting and Exposition by Rau.1 |
| Key learnings |
| Compared with chemotherapy alone, blinatumomab plus chemotherapy improved the 3-year DFS in both SR-average (HR, 0.33; 90.2% vs 97.5%) and SR-high (HR, 0.45; 84.8% vs 94.1%) pediatric patients with B-ALL. |
| In both SR-average and SR-high groups, the risk of relapse was lower in the blinatumomab plus chemotherapy group compared with the chemotherapy-only group (p = 0.002 for each group). Blinatumomab plus chemotherapy reduced isolated BM relapse, but not isolated CNS relapse (p < 0.001 and p = 0.85, respectively, for the overall cohort). |
| Blinatumomab plus chemotherapy was well tolerated; however, there were higher rates of sepsis and catheter-related infections in patients with SR-average B-ALL. Overall, there was no difference in Grade 4 or 5 infectious toxicity. |
| The findings suggest that the addition of blinatumomab to chemotherapy is a new standard treatment choice for children with newly diagnosed SR B-ALL. |
Abbreviations: B-ALL, B-cell acute lymphoblastic leukemia; BM, bone marrow; CNS, central nervous system; DFS, disease-free survival; HR, hazard ratio; SR, standard risk.
- Rau R. Blinatumomab added to chemotherapy improves disease-free survival in newly diagnosed NCI standard risk pediatric B-acute lymphoblastic leukemia: Results from the Randomized Children Oncology Group Study AALL1731. Oral abstract #1. 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 8, 2024; San Deigo, US.
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