June 10, 2016

Amgen has announced new data from an interim analysis of the Phase 3 TOWER study, in which BLINCYTO® (blinatumomab) confirmed nearly two-fold increase in median overall survival (OS) compared to standard of care (SOC). The randomized, open-label TOWER study estimated the effectiveness of BLINCYTO versus SOC chemotherapy in adult patients with Philadelphiachromosome-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 compared to 4 months (95 percent CI: 2.9, 5.3) for SOC (stratified log-rank test p=.012; hazard ratio=0.71).

Max S. Topp, M.D., professor and head of haematology, University Hospital of Wuerzburg, Germany, said: “Acute lymphoblastic leukaemia is the most aggressive type of B-cell malignancy. The data presented today not only reinforce the potential of immunotherapy delivered by T cell engaging bispecific antibody constructs but also validate the efficacy of BLINCYTO in these heavily pretreated patients.”

“This is the first study of an immunotherapy to demonstrate overall survival benefit in adult patients with Ph-negative B-cell precursor relapsed or refractory ALL, a very complex-to-treat disease with limited treatment options. BLINCYTO is currently approved for the treatment of Ph-negative B-cell precursor relapsed or refractory ALL under accelerated approval, and we look forward to working with regulatory authorities for a full approval for BLINCYTO in this patient population,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

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