TOPLINE:

In a final 5-year follow-up analysis of a phase 3 trial, blinatumomab consolidation therapy demonstrated superior event-free survival and overall survival than conventional chemotherapy among children with high-risk first-relapse B-cell precursor acute lymphoblastic leukaemia (B-ALL).

METHODOLOGY:

• This phase 3, open-label, multicentre study included 111 children (aged from > 28 days to < 18 years) with Philadelphia chromosome-negative high-risk first-relapse B-ALL between November 2016 and August 2019.
• Patients were randomly assigned in a 1:1 ratio to receive either blinatumomab as a continuous intravenous infusion at 15 μg/m²/d for 4 weeks (n = 54) or conventional chemotherapy (n = 57).
• The primary outcome was event-free survival, with events including mortality, second relapse, secondary malignancy, and failure to achieve or maintain complete morphologic remission; secondary outcomes included overall survival, the incidence of relapse, the survival rate after 100 days of allogenic haematopoietic stem cell transplantation (alloHSCT), and the incidence of adverse events.
• Overall, 96% of patients in the blinatumomab group and 86% of those in the conventional chemotherapy group completed the treatment.

TAKEAWAY:

• After a median follow-up of 51.9 months, the rate of event-free survival was significantly higher with blinatumomab than with conventional chemotherapy (61.1% vs 35.1%; hazard ratio, 0.38; P < .001).
• A marked improvement in overall survival was observed with blinatumomab vs conventional chemotherapy (79.6% vs 50.9%; stratified log-rank P = .001). Patients in the blinatumomab group showed a higher probability of relapse-free survival than those in the conventional chemotherapy group (63.0% vs 31.4%; P < .001), with one patient in the blinatumomab group developing secondary malignancy.
• The cumulative incidence of non-relapse mortality at 12 months was not significantly different between the two groups; more patients in the conventional chemotherapy group died due to relapse or disease progression than those in the blinatumomab group (31.6% vs 11.1%), and relapses with death due to causes other than disease progression were lower with blinatumomab vs conventional chemotherapy (9.3% vs 17.5%).
• The proportion of patients proceeding to alloHSCT was significantly higher in the blinatumomab group than in the conventional chemotherapy group (94.4% vs 68.4%; P = .0005). The median time to death in the conventional chemotherapy group was 51.1 months, with a high number of patients in the blinatumomab group being alive after the transplant (79.5% vs 46.6%).
• No deaths occurred due to the treatments given in the trial. Patients in the blinatumomab group experienced a lower incidence of adverse events of grade 3 or higher than those in the conventional chemotherapy group (16.7% vs 63.5%; P < .001).

IN PRACTICE:

"As demonstrated by the updated OS [overall survival] data, the outcomes have significantly improved since the prior interim analysis," the authors wrote, noting that "the plateau effect is now more pronounced, indicating a sustained long-term benefit with blinatumomab consolidation."

SOURCE:

This study was led by Franco Locatelli, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy. It was published online on November 13, 2025, in Leukemia.

LIMITATIONS:

No limitations were reported in this study.

DISCLOSURES:

This study was funded by Amgen Inc. Two authors reported being employees of Amgen Inc. Several authors reported receiving honoraria, being members of the speakers bureau, and having other ties with various sources. Full disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.