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Blood Cancer J. 2016 Sep 23;6(9):e473. doi: 10.1038/bcj.2016.84.

Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia.

Author information

1
Department of Medicine, University Hospital, Goethe University, Frankfurt, Germany.
2
Center for Observational Research, Thousand Oaks, CA, Amgen, USA.
3
Department of Hematology/Oncology, Cleveland Clinic, Cleveland, OH, USA.
4
Unità Operativa Complessa di Ematologia, Ospedale dell'Angelo, Mestre-Venezia, Italy.
5
Blood Disease Department (Leukemia Unit), Hôpital Saint-Louis, Paris, France.
6
Department of Internal Medicine - Hematology and Oncology, University Hospital, Brno, Czech Republic.
7
Research Department of Haematology, UCL Cancer Institute, London, UK.
8
Department of Bone Marrow Transplantation and Onco-Hematology, Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Gliwice, Poland.
9
Department of Biostatistics, Uxbridge, Amgen Ltd, UK.
10
Department of Biostatistics, Amgen Inc., Rockville, MD, USA.
11
Blood Diseases Service, Center Hospitalier Universitaire, Angers, France.
12
Department of Clinical Development, Amgen Inc., Thousand Oaks, CA, USA.
13
Institute of Hematology and Medical Oncology "L. and A. Seragnoli" S. Orsola University Hospital, Bologna, Italy.
14
Clinical Hematology Department, ICO-Hospital Germans Trias I Pujol. Jose Carreras Research Institute, Barcelona, Spain.
15
Department of Leukemia, University of Texas MD Cancer Center, Houston, TX, USA.
16
Department of Hematology and Bone Marrow Transplantation, Rambam Medical Center, Haifa, Israel.
17
Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA, USA.
18
Medizinische Klinik und Poliklinik II, Universitätsklinikums Würzburg, Würzburg, Germany.
19
Department of Medicine, Dana Farber Cancer Institute, Boston, MA, USA.

Abstract

We compared outcomes from a single-arm study of blinatumomab in adult patients with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia (R/R ALL) with a historical data set from Europe and the United States. Estimates of complete remission (CR) and overall survival (OS) were weighted by the frequency distribution of prognostic factors in the blinatumomab trial. Outcomes were also compared between the trial and historical data using propensity score methods. The historical cohort included 694 patients with CR data and 1112 patients with OS data compared with 189 patients with CR and survival data in the blinatumomab trial. The weighted analysis revealed a CR rate of 24% (95% CI: 20-27%) and a median OS of 3.3 months (95% CI: 2.8-3.6) in the historical cohort compared with a CR/CRh rate of 43% (95% CI: 36-50%) and a median OS of 6.1 months (95% CI: 4.2-7.5) in the blinatumomab trial. Propensity score analysis estimated increased odds of CR/CRh (OR=2.68, 95% CI: 1.67-4.31) and improved OS (HR=0.536, 95% CI: 0.394-0.730) with blinatumomab. The analysis demonstrates the application of different study designs and statistical methods to compare novel therapies for R/R ALL with historical data.

Conflict of interest statement

NG and J-MR have received research support and honoraria from Pfizer and Amgen. AA has received research support from Pfizer and Amgen and honoraria from Pfizer. RB and SG have received honoraria from Amgen. AS has served on speakers' bureau and advisory boards for Amgen. VC, AK, MK and JS are employees and shareholders of Amgen; VH and TM were employees of Amgen when the study was conducted. The remaining authors declare no competing interests.

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