Blinatumomab Plus Consolidation Chemotherapy Is ‘New Standard of Care’ in B-Lineage ALL

Adding blinatumomab to consolidation chemotherapy for newly diagnosed patients with B-lineage acute lymphoblastic leukemia (B-lineage-ALL) led to significantly better overall survival (OS) compared with chemotherapy alone, representing a new standard of care. However, investigators said that more work is needed to determine the ideal dosage in terms of the number of treatment cycles.

Led by Selina Luger, MD, FRCPC, of the Perelman School of Medicine in the Hospital of the University of Pennsylvania, this subgroup analysis of the ECOG ACRIN E1910 phase III trial was designed to assess the “outcomes of [patients] in the blinatumomab arm of the trial who received all four cycles of blinatumomab compared to those who received one or two cycles,” the authors wrote, based on the fact that not all patients in the trial were able to receive all four planned cycles of blinatumomab in consolidation.

In the blinatumomab arm of the of the ECOG ACRIN E1910 study, 12 patients received one cycle (11%), 32 patients received two cycles (29%), four patients received three cycles (4%) and 63 patients received four cycles (57%).

When the OS of patients who received only one or two cycles of blinatumomab was compared to the control arm, the difference was not significant (hazard ratio (HR), 0.62; 95% CI, 0.28-1.34, P=.22). However, the OS of those who received all four cycles was significantly higher than those who received only one or two cycles (HR, 0.39; 95% CI, 0.12-1.16, P=.076).

“The addition of blinatumomab to consolidation chemotherapy resulted in a significantly better overall survival compared to chemotherapy alone in [patients] with newly diagnosed B-lineage ALL who were MRD negative after intensification,” the authors wrote. “This represents a new standard of care for [patients] aged 30-70 years with BCR-ABL1 negative ALL.”

However, the authors noted that the optimal dose and number of cycles is still unknown, and that they were only able to demonstrate a survival benefit in patients who received the intended four cycles of blinatumomab during consolidation.

Reference

Luger S, Sun Z, Mattison R, et al. Assessment of outcomes of consolidation therapy by number of cycles of blinatumomab received in newly diagnosed measurable residual disease negative patients with B-lineage acute lymphoblastic leukemia: in the ECOG-ACRIN E1910 randomized phase III National Clinical Trials Network Trial. Abstract #2877. Presented at the 65th ASH Annual Meeting and Exposition; December 9-12, 2023; San Diego, California.