The addition of the bispecific T-cell engager blinatumomab to consolidation chemotherapy in adults patients with BCR::ABL1-negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who had measurable residual disease (MRD)-negativity “significantly improved overall survival” (OS), according to an interim analysis of a phase 3 trial published in the New England Journal of Medicine.
“The addition of blinatumomab to consolidation chemotherapy in adult patients in MRD-negative remission from BCP-ALL significantly improved overall survival.” Mark Litzow, MD, a professor of medicine in the Division of Hematology at the Mayo Clinic in Rochester, Minnesota, and colleagues wrote in the NEJM article.
Patients were randomly assigned to receive 4 cycles of blinatumomab in addition to 4 cycles of consolidation chemotherapy or to receive 4 cycles of consolidation chemotherapy alone after induction chemotherapy. The trial enrolled 488 patients who were 30 to 70 years of age with BCR::ABL1-negative BCP-ALL who had MRD-negative remission.
At a median follow-up of 43 months, the blinatumomab group had a better OS than the chemotherapy-only group (at 3 years, 85% vs. 68%; hazard ratio [HR] for death, 0.41; 95% CI, 0.23-0.73; P=0.002). The 3-year relapse-free survival was 80% with blinatumomab and 64% with chemotherapy alone (HR, 0.53; 95% CI, 0.32-0.87). A higher incidence of neuropsychiatric events was reported in the blinatumomab group compared with the chemotherapy-only group, the authors reported.
Dr. Litzow and colleagues noted that the results of the interim analysis were released at the recommendation of the trial’s data and safety monitoring committee. The phase III trial is estimated to be completed in December 2024, according to the study details posted on ClinicalTrials.gov.
Reference
Litzow M, Sun Z, Mattison R, et al. Blinatumomab for MRD-negative acute lymphoblastic leukemia in adults. N Engl J Med. 2024;391(4):320-333. doi:10.1056/NEJMoa2312948
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