Two phase 3 studies show efficacy of blinatumomab over chemotherapy for pediatric leukemia
Blinatumomab significantly extended EFS compared with conventional consolidation chemotherapy among children with high-risk B-cell acute lymphoblastic leukemia in first relapse, according to results of a prespecified interim analysis of the phase 3 20120215 study reported by the agent’s manufacturer.
Blinatumomab (Blincyto, Amgen) — a bispecific CD19-directed CD3 T cell engager antibody construct — also demonstrated a “strong trend” toward improved DFS and OS, 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 AALL1331 study, according to the press release.
Both studies have stopped enrollment early based on the treatment benefit with blinatumomab. Specifically, enrollment 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.
Adverse events observed in both trials are consistent with previous reports of blinatumomab’s safety profile.
“Considered together, the results of these studies are remarkable,” David M. Reese, MD, executive vice president of research and development at Amgen, said in the press release. “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.”