Blinatumomab + Interfant‑06 chemotherapy for infant KMT2A‑r B‑ALL

A prospective single-arm, interventional, multicenter, phase II study investigated the safety and efficacy of blinatumomab + Interfant-06 chemotherapy (CTX), vs Interfant‑06 CTX alone, in 30 infants (aged <12 months) with KMT2A-rearranged (KMT2A‑r) CD19⁺ B-cell acute lymphoblastic leukemia (B‑ALL). Key endpoints were disease-free survival (DFS), overall survival (OS), and safety. Results were published in the Journal of Clinical Oncology by Martins et al.  

Key data: The median follow-up was 4.2 years (range, 3.2–6.0). DFS at 4 years was 83.3% (95% confidence interval [CI], 64.5–92.7) in patients receiving blinatumomab + Interfant‑06 CTX vs 44.0% (n = 214; 95% CI, 37.0–50.8) in patients receiving Interfant‑06 alone. The 4-year OS was 93.3% (95% CI, 75.9–98.3) in patients receiving blinatumomab + Interfant‑06 CTX vs 60.2% (95% CI, 53.0–66.7) in patients receiving Interfant‑06 CTX alone. The 4-year cumulative incidence of relapse in patients receiving blinatumomab + Interfant‑06 CTX was 13.3% (95% CI, 4.1–28.1) vs 49.6% (95% CI, 42.5–56.3) in patients receiving Interfant‑06 CTX alone. Severe infections (Grade ≥3) occurred in 70% of patients overall, with 17% experiencing them during treatment with blinatumomab.  

Key learning: Blinatumomab + Interfant‑06 CTX demonstrated durable benefits in DFS and OS in infant patients with KMT2A‑r B‑ALL compared with Interfant‑06 CTX alone, supporting its potential use in frontline therapy, dependent on confirmation in ongoing trials.