Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL

MS Topp, N Gökbuget, G Zugmaier… - Blood, The Journal …, 2012 - ashpublications.org
MS Topp, N Gökbuget, G Zugmaier, E Degenhard, ME Goebeler, M Klinger, SA Neumann…
Blood, The Journal of the American Society of Hematology, 2012ashpublications.org
Persistence or recurrence of minimal residual disease (MRD) after chemotherapy results in
clinical relapse in patients with acute lymphoblastic leukemia (ALL). In a phase 2 trial of B-
lineage ALL patients with persistent or relapsed MRD, a T cell–engaging bispecific Ab
construct induced an 80% MRD response rate. In the present study, we show that after a
median follow-up of 33 months, the hematologic relapse-free survival of the entire evaluable
study cohort of 20 patients was 61%(Kaplan-Meier estimate). The hema-tologic relapse-free …
Abstract
Persistence or recurrence of minimal residual disease (MRD) after chemotherapy results in clinical relapse in patients with acute lymphoblastic leukemia (ALL). In a phase 2 trial of B-lineage ALL patients with persistent or relapsed MRD, a T cell–engaging bispecific Ab construct induced an 80% MRD response rate. In the present study, we show that after a median follow-up of 33 months, the hematologic relapse-free survival of the entire evaluable study cohort of 20 patients was 61% (Kaplan-Meier estimate). The hema-tologic relapse-free survival rate of a subgroup of 9 patients who received allogeneic hematopoietic stem cell transplantation after blinatumomab treatment was 65% (Kaplan-Meier estimate). Of the subgroup of 6 Philadelphia chromosome–negative MRD responders with no further therapy after blinatumomab, 4 are in ongoing hematologic and molecular remission. We conclude that blinatumomab can induce long-lasting complete remission in B-lineage ALL patients with persistent or recurrent MRD. The original study and this follow-up study are registered at www.clinicaltrials.gov as NCT00198991 and NCT00198978, respectively.
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