GIMEMA LALl2317: Sequential Chemotherapy and Blinatumomab for Adult ALL

Data from the following presentations are discussed:

• Preliminary results of the GIMEMA LAL2317 sequential chemotherapy-blinatumomab front-line trial for newly diagnosed adult Ph-negative B-lineage ALL patients. (Bassan, EHA 2021 S114)
  • Efficacy: The preliminary analysis demonstrated the efficacy of blinatumomab added to chemotherapy in increasing minimal residual disease (MRD) negativity (<10-4) in CD19+ B-lineage Philadelphia Chromosome positive acute lymphoblastic leukemia, with the primary study endpoint being completely achieved. Statistically, hematological CR (complete remission) was achieved in 131 patients, equaling 90.4% where 7 were resistant, 7 died early, and 1 was not evaluable. Comparatively, within the primary study endpoint, the MRD clearance after blinatumomab course 1 resulted in 85 patients with paired MRD samples who were evaluable. Following early consolidation, 73% of these patients were classified as MRD-negative (<10-4). As a result, this increased to 96% after the first blinatumomab administration (P = 0.018). Moreover, there was a conversion rate from MRD positivity to MRD negativity of 87%, specifically 20 out of 23 patients.
  • Safety: A 12-month relapse incidence of 11% (15 relapses) was observed in patients treated with blinatumomab and was not impacted by MRD (positive, negative, or undefined). Additionally, the effect of the treatment results resulted in a lower early relapse rate, which was detectable in every risk subset.

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