Replacing two high-dose chemotherapy courses with blinatumomab (Blincyto) significantly improved event-free survival (EFS) in pediatric patients with newly diagnosed high-risk B-cell acute lymphoblastic leukemia (ALL), an interim analysis from a phase III trial showed.
The 4-year EFS rate was 83% for those treated with the bispecific T-cell engager versus 70.3% for those treated with chemotherapy (HR 0.51, 95% CI 0.35-0.73, P=0.0002), thus meeting the trial's primary endpoint of at least a 10% EFS improvement, reported Martin Schrappe, MD, PhD, of the University Medical Center Schleswig-Holstein in Kiel, Germany, at the European Hematology Association annual congress in Stockholm.
In addition, "both systemic- and central nervous system [CNS]-related relapses have been reduced by replacing chemotherapy in favor of introducing blinatumomab," Schrappe noted.
Specifically, the 4-year cumulative incidence of relapse was 11.8% in the blinatumomab arm compared with 21.4% in the chemotherapy arm.
"Most striking was the reduction in isolated CNS relapses," Schrappe observed, with only one in the experimental arm compared with nine in the control arm.
