- In patients with newly diagnosed acute B-cell acute lymphoblastic leukemia (B-ALL) without measurable minimal residual disease (MRD-negative) after initial treatment, the use of blinatumomab in addition to consolidation chemotherapy resulted in a significant improvement in overall survival (OS).
- This consolidation therapy may represent a new standard of care for this patient population.
Why this matters
- Although the risk of relapse is lower in MRD-negative patients than in MRD-positive patients, there is a risk of relapse.
- Blinatumomab, a bispecific antibody developed to guide cytotoxic T cells to CD19-expressing cancer cells, is already approved for refractory/relapsed B-ALL and MRD-positive B-ALL in adults and children.
Study design
- In the ECOG-ACRIN-E1910 study, 488 Patients (ages: 30–70) with newly diagnosed BCR-ABL-negative B-ALL enrolled.
- Patients who achieved remission after induction chemotherapy received intensification chemotherapy, were tested for their MRD status (cut-off for positivity: ≥ 0.01 %), then randomized (1 : 1) and received 4 Cycles of consolidation chemotherapy with or without (±) 4 Cycles blinatumomab.
- The investigators initially wanted to randomize both MRD-positive and MRD-negative patients, but following the FDA’s approval of blinatumomab for MRD-positive disease (March 2018), MRD-positive patients were assigned to the blinatumomab arm of the study.
- After completion of consolidation therapy (chemotherapy ± blinatumomab), patients received maintenance chemotherapy.The median follow-up at the time of analysis was 43 Months.
Key results
- Among MRD-negative patients (n = 224), patients in the blinatumomab arm had significantly improved survival compared to patients in the standard treatment arm (median OS: not reached vs. 71.4 Months; HR: 0.42 [95 % CI: 0.24-0.75]; p = 0.003).
- According to 3.6 years, 83 % of patients in the blinatumomab arm were alive, vs. 67 % in the chemotherapy-only arm.
- Patients treated with blinatumomab also had significantly improved recurrence-free survival (RFS) (median RFS: not reached vs. 22.4 Months; HR: 0.46 [95 % CI: 0.27-0.78]; p = 0.004).
- The combination was generally well tolerated with no new safety signals reported.
Funding
- National Cancer Institute, Amgen
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Source — https://www.univadis.de/viewarticle/ash2022remission-und-uberlebensvorteil-mit-blinatumomab-bei-erwachsenen-mit-b-all
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