New England Journal of Medicine· 2026Q1
Ponatinib–Blinatumomab or Imatinib–Chemotherapy for Adult Ph-Positive ALL
- 1citations
- Q1SCImago
- 2026year
Short summary
A frontline chemotherapy-free approach combining ponatinib and blinatumomab resulted in significantly higher 24-month event-free survival (86% vs. 67%) compared to imatinib plus chemotherapy in adult Philadelphia-chromosome-positive acute lymphoblastic leukemia (Ph-positive ALL).
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Key points
- Ponatinib plus blinatumomab led to 86% 24-month event-free survival, compared to 67% with imatinib plus chemotherapy (P<0.001).
- Complete hematologic response was achieved in 94% of patients on ponatinib-blinatumomab versus 79% on imatinib-chemotherapy.
- Molecular response rates after consolidation were 71% for ponatinib-blinatumomab and 49% for imatinib-chemotherapy.
- The chemotherapy-free targeted and immunotherapeutic approach was found to be superior in this frontline treatment trial.
AI-generated from the title and abstract; the full text is not read.
Abstract
BACKGROUND: The outcome of Philadelphia-positive acute lymphoblastic leukemia (Ph-positive ALL) has greatly improved with the use of tyrosine kinase inhibitors and immunotherapy. METHODS: In this trial, we randomly assigned adult patients with Ph-positive ALL in a 2:1 ratio to receive ponatinib plus blinatumomab (intervention group) or imatinib plus chemotherapy (control group) as frontline treatment. A crossover to the intervention group was allowed for patients with persistence or reappearance of measurable residual disease in the control group. The primary end point was event-free survival. RESULTS: A total of 236 patients underwent randomization: 158 to the intervention group and 78 to the control group. The median age of the patients was 55 years (range, 24 to 82). At a median follow-up of 23.7 months, the estimated 24-month event-free survival was 86% in the intervention group and 67% in the control group (P<0.001). Survival with no measurable residual disease was 68% and 42%, respectively. At the end of induction, a complete hematologic response was observed in 94% of the patients in the intervention group and in 79% of those in the control group. After blinatumomab consolidation, a molecular response was observed in 71% and 49% of the patients, respectively. After crossover to the intervention group, 20 of 31 patients (64%) had a molecular response. Overall survival was 90% in the intervention group and 85% in the control group. The cumulative incidence of relapse was 5% and 13%, respectively. As of this report, only 19% of the patients in the intervention group had undergone hematopoietic stem-cell transplantation after having had a first complete hematologic response. CONCLUSIONS: In this phase 3 trial, a frontline chemotherapy-free targeted and immunotherapeutic approach was superior to the use of imatinib and chemotherapy. (Funded by Associazione Italiana per la Ricerca sul Cancro and others; GIMEMA ALL2820 ClinicalTrials.gov number, NCT04722848.).
The authors' abstract, as published at the source. New England Journal of Medicine, 2026 · DOI ↗
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Field: Public Health, Environmental and Occupational Health
Public Health, Environmental and Occupational HealthMedicine