measurable residual disease (MRD)-negative showed an overall survival (OS) benefit if they were treated with a consolidation therapy of blinatumomab plus chemotherapy compared with chemotherapy alone. The authors concluded that these results represent a new potential standard-of-care for this group of patients.
The phase 3 ECOG-ACRIN-E1910 NCTN clinical trial exposed patients with newly diagnosed B-ALL to 2.5 months of Berlin-Frankfurt-Munster (BFM) induction chemotherapy, modified from the UKALL-XII protocol.1,2 Those with a complete remission (CR) or a complete remission with incomplete count recovery (CRi) received CNS treatment intensification with high-dose methotrexate plus pegaspargase. MRD status was then assessed, and patients were randomized 1:1 to consolidation chemotherapy plus four 28-day cycles of blinatumomab or to chemotherapy alone. All randomized patients received 2.5 years of POMP maintenance chemotherapy. The current study aimed to compare the blinatumomab-containing regimen with the chemotherapy-only arm for OS in MRD-negative patients (N=224). Dr. Mark Litzow (Mayo Clinic) presented the results, at the 2022 annual meeting of the American Society of Hematology, after a median follow-up time of 43 months.
There was a clear OS benefit for patients in the blinatumomab arm compared with patients in the chemotherapy alone arm (median OS, not reached vs 71.4 months; HR, 0.42; 95% CI, 0.24-0.75; log-rank P=0.003). Dr. Litzow added that the 3.5-year OS-rates were 83% and 65%, respectively. Similarly, the relapse-free survival comparison favored the blinatumomab arm over the chemotherapy arm (not reached vs 22.4 months; HR, 0.46; 95% CI, 0.27-0.78; log rank P=0.004). According to Dr. Litzow, the combination therapy was well tolerated and no new safety issues were observed.
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