Results of a prespecified interim analysis of the phase 3 TOWER study evaluating blinatumomab in patients with B-cell precursor acute lymphoblastic leukemia (ALL) showed that the primary endpoint of improved overall survival was met.1
As a result, the independent data monitoring committee recommended that the study be stopped early for efficacy.
“The FDA’s breakthrough therapy designation and accelerated approval of Blincyto [blinatumomab] underscore the dire prognosis for these patients. This is the first study to demonstrate an overall survival benefit for these patients with an immunotherapy, and this is a tremendously rare achievement in relapsed and refractory ALL,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “We will work with regulatory authorities towards a full approval for Blincyto in this population.”
For the open-label, phase 3 trial, researchers randomly assigned adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL in a 2:1 ratio to receive blinatumomab or 1 of 4 standard of care chemotherapy regimens per the investigator’s choice.
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In terms of safety, reported adverse events of the immunotherapy were consistent with the known safety profile of blinatumomab. Secondary endpoints are being evaluated and Amgen plans to submit their interim data to a future medical conference and for publication.
Blinatumomab is a bispecific CD19-directed CD3 T-cell engager (BiTE) already approved by the U.S. Food and Drug Administration for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL. Approval was based on the complete remission/complete remission with partial hematological recovery rate.
- Phase 3 study of Blincyto® (blinatumomab) met primary endpoint of overall survival in patients with b-cell precursor acute lymphoblastic leukemia [news release]. Thousand Oaks, CA: Amgen; February 4, 2016. http://www.amgen.com/media/news-releases/2016/02/phase-3-study-of-blincyto-blinatumomab-met-primary-endpoint-of-overall-survival-in-patients-with-bcell-precursor-acute-lymphoblastic-leukemia. Accessed February 5, 2016.