Amgen Reports Results of Blincyto (blinatumomab) in Two P-III Studies for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients

Amgen Reports Results of Blincyto (blinatumomab) in Two P-III Studies for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients

Shots:

  • The P-III 20120215 study involves assessing of Blincyto vs SoC consolidation CT in pediatric patients with high-risk first relapsed B-cell ALL, being conducted as part of the PIP agreed b/w Amgen & the EMA, resulted in meeting its 1EPs of event-free survival
  • The P-III COG AALL1331 study involves assessing of Blincyto +CT vs CT as monothx. to evaluate DFS of HR/IR relapsed B-ALL patients who are randomized following induction block 1 CT to receive either two intensive CT blocks or two 5-wks. blocks of blinatumomab
  • Blincyto is a bispecific CD19-directed CD3 T cell engager (BiTE) Ab designed to bind CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. The two P-III studies were stopped early due to treatment benefits of Blincyto over CT

Click here to­ read full press release/ article | Ref: Amgen | Image: The Wall Street Journal