Blinatumomab plus consolidative chemotherapy or allogeneic transplant represents a new standard of care for patients with B-cell acute lymphoblastic leukemia (B-ALL) who achieve minimal residual disease (MRD) negativity after induction and intensification, according to researchers.
Adding blinatumomab to consolidative chemotherapy or transplant improved both overall survival (OS) and relapse-free survival (RFS) in a phase 3 study, according to Mark R. Litzow, MD, of the Mayo Clinic in Rochester, Minnesota.
Dr Litzow presented these results, from the phase 3 ECOG-ACRIN E1910 trial (ClinicalTrials.gov Identifier: NCT02003222), at the 2022 ASH Annual Meeting.
The trial enrolled 488 adults, aged 30-70 years, with newly diagnosed BCR-ABL1-negative B-ALL. All patients received a Berlin-Frankfurt-Munster-like induction regimen. Patients who achieved a complete response (CR) or CR with incomplete count recovery after induction received central nervous system intensification.
After intensification, 224 MRD-negative patients were randomly assigned to 2 treatment arms. One arm received consolidative chemotherapy or allogeneic transplant. The other arm received blinatumomab plus consolidative chemotherapy or allogeneic transplant. In each arm, 22 patients underwent transplant.
After consolidation, all patients received maintenance therapy for up to 2.5 years. Details on the various treatment regimens can be found here.
At a median follow-up of 43 months, OS was significantly longer in the blinatumomab arm. The median OS was not reached in the blinatumomab arm and was 71.4 months in the chemotherapy-alone arm (hazard ratio [HR], 0.42; 95% CI, 0.24-0.75; P =.003).
RFS was longer with blinatumomab as well. The median RFS was not reached with blinatumomab and was 22.4 months with chemotherapy alone (HR, 0.46; 95% CI, 0.27-0.78; P =.004).
Dr Litzow noted that the blinatumomab combination was generally well tolerated, and no new safety signals emerged. Adverse events were not reported in the presentation.
“[C]onsolidation with blinatumomab combined with chemotherapy has shown, for the first time, an overall survival advantage for adult patients with MRD-negative, BCR-ABL1-negative, B-lineage acute lymphoblastic leukemia,” Dr Litzow said in closing. “We believe that these results represent a new standard of care for this group of MRD-negative patients.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Litzow MR, Sun Z, Paietta E, et al. Consolidation therapy with blinatumomab improves overall survival in newly diagnosed adult patients with B-lineage acute lymphoblastic leukemia in measurable residual disease negative remission: Results from the ECOG-ACRIN E1910 randomized phase III National Cooperative Clinical Trials Network Trial. Presented at ASH 2022. December 10-13, 2022. Abstract LBA-1.