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BLINCYTO (Blinatumomab) Improved Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia

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AMGN

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Additional Relevant Details Amgen announced new data from a prespecified interim analysis of the Phase 3 TOWER study, in which BLINCYTO (blinatumomab) demonstrated an almost two-fold increase in median overall survival (OS) compared to standard of care (SOC). The randomized, open-label TOWER study evaluated the efficacy of BLINCYTO versus SOC chemotherapy in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Results from the analysis showed that median OS was 7.7 months (95 percent CI: 5.6, 9.6) for BLINCYTO versus 4 months (95 percent CI: 2.9, 5.3) for SOC (stratified log-rank test p=.012; hazard ratio=0.71). As per the recommendation of an independent data monitoring committee, Amgen ended the study early for efficacy based on these results. The data will be presented during The Presidential Symposium at the 21st Congress of the European Hematology Association (EHA) in Copenhagen.
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Catalyst Date
Occurred on:
Jun 10, 2016
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Related Keywords Blincyto, Blinatumomab, B-cell, Acute Lymphoblastic Leukemia, Phase 3 Tower Study