ASH 2023 | Final results of the GIMEMA LAL2317 trial: sequential chemotherapy + blinatumomab for Ph- B-ALL
Sabina Chiaretti, MD, PhD, University of Rome, Rome, Italy, discusses the final results of the Phase II GIMEMA LAL2317 trial (NCT03367299), assessing sequential chemotherapy plus blinatumomab in patients with Philadelphia chromosome negative B-cell acute lymphoblastic leukemia (Ph- B-ALL). The trial demonstrated the benefit of including blinatumomab in the treatment of these patients, with an increase in measurable residual disease (MRD) negativity observed. After a three-year follow up, the overall survival (OS) and disease-free survival (DFS) were better than in historical results, particularly in patients up to the age of 55. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (edited for clarity)
Yeah, this is a very important abstract because it’s a study for Philadelphia negative ALL, with the upper age limit of 65 years. And it was based on a pediatric inspired, MRD-driven trial in which we use intensive chemotherapy with the addition of two cycles of blinatumomab, the first one immediately after the first cycle of induction or consolidation, and the second one later on in consolidation...
Yeah, this is a very important abstract because it’s a study for Philadelphia negative ALL, with the upper age limit of 65 years. And it was based on a pediatric inspired, MRD-driven trial in which we use intensive chemotherapy with the addition of two cycles of blinatumomab, the first one immediately after the first cycle of induction or consolidation, and the second one later on in consolidation.
And the primary objective of the study was to show if blinatumomab could increase the MRD negativity rate in these patients, and indeed, this proved to be the case because the MRD negativity raised from 70% after consolidation until 93% in the other cases. And this indeed turned out to be also successful in terms of overall survival and disease-free survival, which now at three years of follow-up, are 71% and 65%. The major increase in overall survival and disease-free survival was stunningly observed in patients up to the age of 55 years, whereas patients who are between 55 and 65 have a lower overall survival rate. And this might be due also to the fact that some we lost some patients during induction because of early deaths. So overall, the study was really successful and we detected 32 relapses, some of them at the CNS level, and most of them were based also on biologically driven causes like Ph-like MEF2D rearrangements and [inaudible].
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Disclosures
Incyte: Membership on an entity’s Board of Directors or advisory committees; Abbvie: Membership on an entity’s Board of Directors or advisory committees; Gilead: Membership on an entity’s Board of Directors or advisory committees; Pfizer: Membership on an entity’s Board of Directors or advisory committees; Amgen: Membership on an entity’s Board of Directors or advisory committees.
