Amgen's Blincyto improves OS in ALL Phase III

Amgen Inc. (NASDAQ:AMGN) said an interim analysis showed Blincyto blinatumomab met the primary overall survival (OS) endpoint vs. standard of care chemotherapy in the open-label Phase III TOWER trial to treat Philadelphia chromosome-negative (Ph-), relapsed or refractory precursor B cell acute lymphoblastic leukemia (ALL). The biotech stopped the study early on the recommendation of the independent DMC.

Blincyto has accelerated approval for the indication based on data from a Phase II trial in which 41.6% of 185 evaluable patients achieved complete remission or complete remission with partial hematologic recovery within two Blincyto treatment cycles. The European Commission granted conditional approval to Blincyto in November. ...