Dr DeAngelo on the FDA Approval of Blinatumomab Consolidation in CD19+, Ph– B-ALL

“The idea of incorporating blinatumomab as consolidation regardless of MRD status has become a standard of care…this now extends beyond just the adult population, and it probably doesn’t matter what the backbone chemotherapy is.”

Daniel DeAngelo, MD, PhD, professor, medicine, Harvard Medical School; chief, Division of Leukemia, institute physician, Dana-Farber Cancer Institute, discusses the clinical implications of the FDA approval of blinatumomab (Blincyto) in the consolidation phase of multiphase chemotherapy for patients with CD19-positive, Philadelphia chromosome (Ph)–negative, B-cell precursor acute lymphoblastic leukemia (B-ALL).

In June 2024, the FDA approved blinatumomab for the treatment of adult and pediatric patients aged 1 month or older with CD19-positive, Ph-negative, B-ALL in the consolidation phase, regardless of minimal residual disease (MRD) status. This approval expanded the use of blinatumomab as a standard of care in B-ALL management.

The regulatory decision was supported by data from the phase 3 ECOG-ACRIN E1910 study (NCT02003222), which evaluated the addition of blinatumomab to multiphase consolidation chemotherapy in patients with newly diagnosed, Ph-negative B-ALL. In this trial, patients in the blinatumomab arm (n = 112) achieved superior overall survival (OS) outcomes compared with those who received chemotherapy alone (n = 112). The 3-year OS rates were 84.8% (95% CI, 76.3%-90.4%) vs 69.0% (95% CI, 58.7%-77.2%), respectively, and the respective 5-year OS rates were 82.4% (95% CI, 73.7%-88.4%) vs 62.5% (95% CI, 52.0%-71.3%). The hazard ratio for 5-year OS was 0.44 (95% CI, 0.25-0.76), confirming the benefit of incorporating blinatumomab into the consolidation regimen.

CD19, being ubiquitously expressed in B-ALL, has made blinatumomab a versatile therapeutic option for this population, DeAngelo says. The agent’s efficacy was first demonstrated in the phase 3 TOWER study (NCT02013167), which established blinatumomab as superior to standard chemotherapy in relapsed/refractory ALL, he notes. The approval of blinatumomab consolidation further underscores blinatumomab’s utility in both adult and pediatric populations, as blinatumomab is now a standard component of consolidation therapy, irrespective of patient MRD status, DeAngelo states.

Blinatumomab is now widely used in various clinical contexts, including as a consolidation therapy in MRD-positive and MRD-negative B-ALL, for relapsed/refractory disease, and in combination with TKIs for patients with Ph-positive B-ALL, the aim of which is to eradicate the lymphoblast clones in the post-remission setting, DeAngelo concludes.