RCT: Blinatumomab Improves Overall Survival in MRD-Negative Acute Lymphoblastic Leukemia Patients – N Engl J Med

Study Design and Population: This phase 3 randomized clinical trial included 488 adults aged 30 to 70 with BCR::ABL1-negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who achieved measurable residual disease (MRD)-negative remission after initial chemotherapy. The study compared the outcomes of patients receiving four cycles of blinatumomab alongside consolidation chemotherapy versus those receiving consolidation chemotherapy alone.

Main Findings: At a median follow-up of 43 months, the blinatumomab group demonstrated a significant improvement in overall survival (85% vs. 68% at 3 years) compared to the chemotherapy-only group, with a hazard ratio for death of 0.41 (95% CI, 0.23 to 0.73; P = 0.002). The 3-year relapse-free survival was also higher in the blinatumomab group (80% vs. 64%), with a hazard ratio for relapse or death of 0.53 (95% CI, 0.32 to 0.87). However, a higher incidence of neuropsychiatric events was noted in the blinatumomab group.

Implications for Practice: The addition of blinatumomab to consolidation chemotherapy significantly enhances overall and relapse-free survival in adult patients with MRD-negative BCP-ALL, suggesting its potential as a standard treatment approach for this population. Clinicians should monitor for neuropsychiatric side effects associated with blinatumomab use.

Reference: Litzow MR et al. (2024). Blinatumomab for MRD-Negative Acute Lymphoblastic Leukemia in Adults. New England Journal of Medicine, 391(4), 320-333. DOI: 10.1056/NEJMoa2312948.