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Blood. 2015 Dec 10;126(24):2578-84. doi: 10.1182/blood-2015-06-649111. Epub 2015 Oct 19.

Long-term survival and T-cell kinetics in relapsed/refractory ALL patients who achieved MRD response after blinatumomab treatment.

Author information

1
Amgen Research (Munich), Munich, Germany;
2
Department of Medicine II, Goethe University Frankfurt, Frankfurt, Germany;
3
Department of Internal Medicine III, University Hospital Ulm, Ulm, Germany;
4
Department of Medicine A, University of Münster, Münster, Germany;
5
Department of Medicine II, Christian-Albrechts-Universität zu Kiel, Kiel, Germany;
6
Department of Medicine I, Albert-Ludwigs-Universität Frieburg, Freiburg, Germany;
7
Department of Medicine II, Eberhard Karls Universität Tübingen, Tübingen, Germany;
8
Department of Hematology and Oncology, Medizinische Hochschule Hannover, Hannover, Germany;
9
Department of Medicine III, University of Regensburg, Regensburg, Germany;
10
Amgen, Rockville, MD; and.
11
Department of Medicine II and.
12
Comprehensive Cancer Center Mainfranken, Universitätsklinikum Würzburg, Würzburg, Germany.

Abstract

This long-term follow-up analysis evaluated overall survival (OS) and relapse-free survival (RFS) in a phase 2 study of the bispecific T-cell engager antibody construct blinatumomab in 36 adults with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). In the primary analysis, 25 (69%) patients with relapsed/refractory ALL achieved complete remission with full (CR) or partial (CRh) hematologic recovery of peripheral blood counts within the first 2 cycles. Twenty-five patients (69%) had a minimal residual disease (MRD) response (<10(-4) blasts), including 22 CR/CRh responders, 2 patients with hypocellular bone marrow, and 1 patient with normocellular bone marrow but low peripheral counts. Ten of the 36 patients (28%) were long-term survivors (OS ≥30 months). Median OS was 13.0 months (median follow-up, 32.6 months). MRD response was associated with significantly longer OS (Mantel-Byar P = .009). All 10 long-term survivors had an MRD response. Median RFS was 8.8 months (median follow-up, 28.9 months). A plateau for RFS was reached after ∼18 months. Six of the 10 long-term survivors remained relapse-free, including 4 who received allogeneic stem cell transplantation (allo-SCT) as consolidation for blinatumomab and 2 who received 3 additional cycles of blinatumomab instead of allo-SCT. Three long-term survivors had neurologic events or cytokine release syndrome, resulting in temporary blinatumomab discontinuation; all restarted blinatumomab successfully. Long-term survivors had more pronounced T-cell expansion than patients with OS <30 months.

PMID:
26480933
PMCID:
PMC4671107
DOI:
10.1182/blood-2015-06-649111
[Indexed for MEDLINE]
Free PMC Article

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