Phase III TOWER study of Blincyto (blinatumomab) in Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, ends early for efficacy- Amgen

Amgen has announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase III TOWER study. The randomized, open-label TOWER study evaluated the efficacy of Blincyto (blinatumomab) versus standard of care (SOC) in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The independent data monitoring committee recommended, and Amgen has accepted, that the study end early for efficacy. The Blincyto adverse events observed in the TOWER study were consistent with the known safety profile of Blincyto. Secondary endpoints are currently being evaluated. These interim data will be submitted to a future medical conference and for publication.

The TOWER study was a Phase III, randomized, open-label study investigating the efficacy of the BiTE antibody Blinctyto versus SOC chemotherapy in adult subjects with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL. Patients were randomized in a 2:1 ratio to receive Blincyto or treatment with investigator choice of one of four protocol defined SOC chemotherapy regimens. The primary endpoint was OS.

Comment: Blincyto received accelerated approval from the FDA in December 2014 and conditional EU approval in December 2015.