U.S. FDA approves blinatumomab as consolidation for adult and pediatric patients with CD19+ B-ALL, irrespective of MRD status

On June 14, 2024, the U.S. Food and Drug Administration (FDA) approved blinatumomab for the treatment of adult and pediatric patients aged 1 month or older who have CD19-positive, Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase of multiphase chemotherapy, irrespective of measurable residual disease status.¹ The decision is based primarily on data from the ECOG-ACRIN E1910 study (NCT02003222), a phase III randomized, controlled trial in adult patients with newly diagnosed, Ph-negative B-ALL, as well as data from study 20120215 (NCT02393859), a randomized, controlled, open-label, multicenter trial including pediatric and young adult patients with Ph-negative BCP ALL.¹

Key data

In the ECOG-ACRIN E1910 study, eligible patients in hematologic complete remission (CR) or CR with incomplete peripheral blood count recovery (CRi) following induction and intensification chemotherapy were randomized 1:1 to receive a consolidation regimen of multiple blinatumomab monotherapy cycles plus multiple cycles of intensive chemotherapy (n = 112) or intensive chemotherapy alone (n = 112).¹

• Addition of blinatumomab to multiphase consolidation chemotherapy resulted in superior overall survival (OS) vs chemotherapy alone; 3-year OS was 84.8% (95% confidence interval [CI], 76.3–90.4) vs 69% (95% CI, 58.7–77.2) in the blinatumomab and chemotherapy arms, respectively.
• At a median follow-up of 4.5 years, the 5-year OS was 82.4 % (95% CI, 73.7–88.4) in the blinatumomab arm and 62.5 % (95% CI, 52.0–71.3) in the chemotherapy arm.

In study 20120215, patients aged >28 days and <18 years were randomized 1:1 to receive blinatumomab or the IntReALLHR2010 HC3 intensive combination chemotherapy as the third consolidation cycle.¹

• The 5-‑year OS was 78.4% (95% CI, 64.2–87.4) vs 41.4% (95% CI, 26.3–55.9) for the blinatumomab and chemotherapy arms, respectively.
• The 5-year relapse-free survival was 61.1% (95% CI, 46.3–72.9) with blinatumomab and 27.6% (95% CI, 16.2–40.3) with chemotherapy.

Conclusion 

This FDA approval marks an important clinical development for this patient population, allowing treatment with blinatumomab irrespective of MRD status, redefining the standard of care for patients with B-ALL.^1,2