GIMEMA LALl2317: Sequential Chemotherapy and Blinatumomab for Adult ALL

Author(s):

Jorge Cortes, MD, Georgia Cancer Center,Robin Foa, MD, Sapienza University

Robin Foà, MD, discusses results from the GIMEMA LAL2317 sequential chemotherapy-blinatumomab frontline trial, where experts evaluated the efficacy of blinatumomab in increasing the early MRD (minimal residual disease) negativity rate.

EP: 1.OPTIC Primary Analysis: a Dose-Optimization Study of 3 Starting Doses of Ponatinib in CML Treatment

EP: 2.Phase II Results: Ponatinib + Blinatumomab in Ph+ ALL

EP: 3.GIMEMA LAL2116, D-ALBA, Updated Results and Prognostic Impact of IKZF1 in Ph+ ALL

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EP: 4.GIMEMA LALl2317: Sequential Chemotherapy and Blinatumomab for Adult ALL

EP: 5.MRD as a Prognostic Indicator in Children and Young Adults with Very High-Risk 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.