Phase III Data of Blinatumomab Shows Prominent Activity in Pediatric Leukemia

Release Date: 03-Oct-2019

According to the reports of Phase III trial of Blinatumomab, Blinatumomab significantly extended event free survival compared with conventional consolidation chemotherapy among children with high-risk B-cell acute lymphoblastic leukemia (ALL) in first relapse. The study is ongoing and it involves a group of Children with acute or chronic leukemia. 

Blinatumomab is a product of Amgen, which is marketed under the brand name of Blincyto. It is a bispecific CD19-directed CD3 T cell engager antibody. It is also demonstrated a positive action toward improved Diseases Free Survival and Overall Survival, better minimal residual disease clearance, and less toxicity compared with chemotherapy among children with B-cell ALL in first relapse enrolled in the Children’s Oncology Group phase 3 studies.

The two studies of phase 3 i.e. phase 3 20120215 study and phase 3 AALL1331 study shows the activity of Blinatumomab against pediatric leukemia. Both the studies have stopped enrollment early based on the treatment benefit with blinatumomab. Specifically, involvement to the high-risk and intermediate-risk groups of the AALL1331 study has been stopped based on a recommendation from the data monitoring committee; however, enrollment to the low-risk group will continue. The main reason for the termination of enrollment is that adverse events observed in both trials are consistent with previous reports of blinatumomab’s safety profile.

According to the David M. Reese, MD, executive vice president of research and development at Amgen, the results of these studies are remarkable. The Children and adolescents who relapse with ALL face a poor prognosis and there remains a need for additional treatment options, particularly for those that are identified as high risk. These data have the potential to be practice-changing and may provide a treatment approach to prevent further relapse that is superior to chemotherapy. We look forward to discussing these data with regulatory authorities.