No toxic effects seen meeting definition of primary end point; profile of toxic effects consistent with that reported in older patients
By Elana Gotkine HealthDay Reporter
THURSDAY, April 27, 2023 (HealthDay News) — For infants younger than 1 year of age with newly diagnosed KMT2A-rearranged acute lymphoblastic leukemia (ALL), a bispecific T-cell engager molecule targeting CD19, blinatumomab, is safe and has a high level of efficacy, according to a study published in the April 27 issue of the New England Journal of Medicine.
Inge M. van der Sluis, M.D., Ph.D., from the Princess Máxima Center for Pediatric Oncology in Utrecht, Netherlands, and colleagues examined the safety and efficacy of blinatumomab in 30 infants younger than 1 year of age with KMT2A-rearranged ALL. The infants were given the chemotherapy used in the Interfant-06 trial with the addition of one postinduction course of blinatumomab. Patients were followed for a median of 26.3 months.
The researchers observed no toxic effects meeting the definition of the primary end point (toxic effect that was possibly or definitely attributable to blinatumomab and resulted in permanent discontinuation of blinatumomab or death). There were 10 serious adverse events reported, including fever, infection, hypertension, and vomiting (four, four, one, and one events, respectively). The profile of toxic effects was consistent with that reported in older patients. After the blinatumomab infusion, 28 patients were minimal residual disease (MRD)-negative or had low levels of MRD. During further treatment, all patients who continued chemotherapy became MRD-negative. In this study, two-year disease-free survival was 81.6 percent compared with 49.4 percent in the Interfant-06 trial, with corresponding values of 93.3 and 65.8 percent for overall survival.
“Blinatumomab added to the Interfant-06 backbone appeared to be safe and had promising efficacy in terms of short-term disease-free survival and the percentage of patients with a complete MRD response,” the authors write.
Funding for the study was provided in part by Amgen, which provided blinatumomab free of charge.
Copyright © 2023 HealthDay. All rights reserved.
