2021 ASCO Virtual Meeting: Leukemia TALK : Episode 4

GIMEMA LALl2317: Sequential Chemotherapy and Blinatumomab for Adult ALL

July 8, 2021

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

Video

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.