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Adding blinatumomab to standard chemotherapy improved survival outcomes in pediatric patients with NCI standard-risk B-cell acute lymphoblastic leukemia (B-ALL) at average or high risk for relapse. The treatment regimen represents a new standard of care for this population.
“We haven’t seen progress in therapies for pediatric patients with B-ALL for approximately two decades,” expressed Dr. Rachel Rau, MD, from the University of Washington. “Also, recent studies have indicated that intensification of chemotherapy will not improve outcomes for these patients.” The current phase 3 AALL1731 trial (NCT03914625) stratified participants according to their risk for relapse after the standard 3-drug induction chemotherapy1. Participants in the average-risk group with detectable MRD at high throughput sequencing (10-6; n=835) were randomly assigned 1:1 to standard consolidation or standard consolidation plus blinatumomab. Participants in the high-risk group with an MRD less than 0.1% by the end of first consolidation (n=605) were allocated to either intensive modified Berlin-Frankfurt-Munster (mBFM) consolidation or mBFM plus blinatumomab.
Participants who received blinatumomab had a significantly improved disease-free survival (DFS) compared with those who had not received this treatment, with 3-year DFS rates of 96.0% and 87.9% (HR 0.39; P<0.0001). This finding was consistent across the average-risk and high-risk subgroups of patients. Furthermore, blinatumomab was associated with reduced isolated marrow relapses, but not with isolated CNS relapses. “This is not surprising, given that blinatumomab has limited access to the brain,” added Dr. Rau.
The rates of grade 3 or higher cytokine release syndrome, seizure, or encephalopathy were lower than 1% in participants receiving blinatumomab. The authors did notice an increased risk for grade 3 or higher sepsis/catheter-related infections in the average-risk group on blinatumomab compared with those not on blinatumomab, with rates of 3% and 0%. “Fortunately, we did not see an overall difference between the groups in rates of grade 4 or 5 infectious toxicity,” mentioned Dr. Rau.
Blinatumomab added to chemotherapy improved important efficacy outcomes and was generally well tolerated in pediatric patients with NCI standard-risk B-ALL with an average or high risk for relapse, offering a new standard-of-care for this population.
Medical writing support was provided by Robert van den Heuvel.
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