Blinatumomab Added to Interfant-06 Chemotherapy “Safe and Efficacious” in Infants with Newly Diagnosed KMT2A-Rearranged ALL

Blinatumomab added to the Interfant-06 chemotherapy regimen appeared safe and was highly efficacious in infants with newly diagnosed KMT2A-rearranged acute lymphoblastic leukemia (ALL) compared with historical controls from the Interfant-06 trial. Two-year disease-free and overall survival were 81.6% and 93.3%, respectively, compared with 49.4% and 65.8%, respectively, in the Interfant-06 trial. Results from the international phase 2 study were reported in the New England Journal of Medicine in April.

Thirty patients aged under 1 year with newly diagnosed KMT2A-rearranged, CD19+, B-precursor ALL who had been treated according to the Interfant-06 protocol and had less than 25% leukemic blasts in the bone marrow were enrolled in the study. After one month of the Interfant-06 induction therapy, patients received one cycle of blinatumomab as a 4-week continuous infusion, after which they continued treatment per the Interfant-06 protocol. The primary endpoint was any toxic effect deemed possibly or definitely attributable to blinatumomab and resulting in death or permanent discontinuation of blinatumomab.

After a median follow-up of 26.3 months, no clinically relevant toxic effects were observed, meeting the primary endpoint. Twenty-eight patients (93%) were either MRD negative (n=16) or had MRD levels below <5 x 10-4 (n=12) after blinatumomab infusion. All patients became MRD negative after further treatment per the Interfant-06 protocol. One patient died for reasons unrelated to blinatumomab; four patients relapsed, all of whom had central nervous system involvement at the time of relapse.

“Longer follow-up is awaited, but the low incidence of relapse after treatment with blinatumomab is remarkable, given that in historical controls relapses occur frequently and

early during therapy,” wrote principal investigator Inge M. van der Sluis, MD, PhD, of the Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands, and coauthors. “It may be useful to focus future work on identifying whether additional courses of blinatumomab will improve outcomes further and whether [hematopoietic stem cell transplantation] will continue to be necessary to cure high-risk patients.”

  • van der Sluis IM, de Lorenzo P, Kotecha RS, et al. Blinatumomab Added to Chemotherapy in Infant Lymphoblastic Leukemia. N Engl J Med. 2023;388(17):1572-1581. doi:10.1056/NEJMoa2214171


Tags: Blinatumomab, trial, ALL, Research, Infant, researchers, acute lymphoblastic leukemia