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Blinatumomab compared with standard of care for the treatment of adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia

Rambaldi, Alessandro, Ribera, Josep-Maria, Kantarjian, Hagop M., Dombret, Hervé, Ottmann, Oliver G., Stein, Anthony S., Tuglus, Catherine A., Zhao, Xiaoyue, Kim, Christopher and Martinelli, Giovanni 2020. Blinatumomab compared with standard of care for the treatment of adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia. Cancer 126 (2) , pp. 304-310. 10.1002/cncr.32558
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Abstract

Background A single‐arm, phase 2 trial demonstrated the efficacy and safety of blinatumomab, a bispecific T‐cell–engaging antibody construct, in patients with relapsed/refractory (r/r) Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL), a rare hematologic malignancy with limited treatment options. This study compared outcomes with blinatumomab with those of a historical control treated with the standard of care (SOC). Methods The blinatumomab trial enrolled adult patients with Ph+ ALL who were r/r to at least 1 second‐generation tyrosine kinase inhibitor (n = 45). Propensity score analysis (PSA) was used to compare outcomes with blinatumomab with those of an external cohort of similar patients receiving SOC chemotherapy (n = 55). The PSA mitigated confounding variables between studies by adjusting for imbalances in the age at diagnosis and start of treatment, sex, duration from diagnosis to most recent treatment, prior allogeneic hematopoietic stem cell transplantation, prior salvage therapy, and number of salvage therapies. Bayesian data augmentation was applied to improve power to 80% with data from a phase 3 blinatumomab study in r/r Philadelphia chromosome–negative ALL. Results In the PSA, the rate of complete remission or complete remission with partial hematologic recovery was 36% for blinatumomab and 25% for SOC, and this resulted in an odds ratio of 1.54 (95% confidence interval [CI], 0.61‐3.89) or 1.70 (95% credible interval [CrI], 0.94‐2.94) with Bayesian data augmentation. Overall survival favored blinatumomab over SOC, with a hazard ratio of 0.81 (95% CI, 0.57‐1.14) or 0.77 (95% CrI, 0.61‐0.96) with Bayesian data augmentation. Conclusions These results further support blinatumomab as a treatment option for patients with r/r Ph+ ALL.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: Wiley
ISSN: 0008-543X
Date of First Compliant Deposit: 12 November 2019
Date of Acceptance: 11 July 2019
Last Modified: 13 Mar 2020 17:12
URI: http://orca.cf.ac.uk/id/eprint/126753

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