Amgen: BLINCYTO Phase 3 Study Meets Primary Endpoint - Quick Facts

(RTTNews) - Amgen (AMGN) announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study. The randomized, open-label TOWER study evaluated the efficacy of BLINCYTO (blinatumomab) versus standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Secondary endpoints are currently being evaluated.

The TOWER study was a Phase 3, randomized, open-label study investigating the efficacy of the BiTE antibody BLINCYTO versus SOC chemotherapy in adult subjects with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.

BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. FDA, and is now approved in the U.S. for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL. This indication is approved under accelerated approval, and may be contingent upon verification of clinical benefit in subsequent trials.