ALL09 SUBLIME: Blinatumomab vs chemotherapy consolidation in de novo ND AYA B-ALL

Results from the phase II, multicenter ALL09 SUBLIME study (ACTRN12618001734257), comparing standard consolidation chemotherapy with blinatumomab in 55 adolescents and young adults (AYA) aged 16–39 years with de novo newly diagnosed (ND) precursor B-cell acute lymphoblastic leukemia (B-ALL), were published in HemaSphere by Greenwood et al. A Simon’s two-stage design evaluated blinatumomab in place of standard consolidation chemotherapy; the primary endpoint was end-consolidation (time point 2 [TP2]) measurable residual disease (MRD)-negativity. 

Key data: Blinatumomab consolidation achieved a TP2 MRD-negativity rate of 70.8% (95% confidence interval [CI], 55.9–83.0%), exceeding the predefined null hypothesis of 60% (p = 0.037). Compared with the prior ALL06 study, median time from protocol I commencement to the next treatment phase was significantly shorter (84 vs 97 days; p = 0.0001), with a higher proportion of patients commencing protocol M or high-risk block therapy by Day 94 (82.7% vs 45.1%; p < 0.0001). After a median follow-up of 42.9 months, the rates of 3-year disease-free survival (DFS) and overall survival (OS) were 88.6% (95% CI, 76.3–94.7%) and 90.5% (95% CI, 78.6–95.9%), respectively. The rates of DFS and OS in patients with standard genomic risk were 100%, while higher-risk patients had poorer DFS. 

Key learning: Blinatumomab consolidation was associated with high MRD-negativity rates and durable survival outcomes in de novo ND AYA B-ALL, supporting its continued evaluation as a chemotherapy-sparing strategy, particularly for patients with standard-risk disease.