Amgen has reported positive data from two Phase III clinical trials of Blincyto (blinatumomab) for the treatment of children with B-cell acute lymphoblastic leukaemia (ALL).
According to pre-specified interim analysis, the drug met the primary endpoint of event-free survival in a global, multi-centre, open-label, randomised, controlled Phase III trial.
The trial compared the safety, efficacy and tolerability of Blincyto to that of consolidation chemotherapy in high-risk paediatric B-cell ALL patients at first relapse.
Based on the favourable efficacy profile, enrolment for the trial was terminated early but the follow up will be continued as per protocol.
During the second Phase III trial involving paediatric B-cell ALL patients at first relapse, Blincyto demonstrated a strong trend for improved disease-free survival and overall survival.
The drug also led to lower toxicity and improved minimal residual disease (MRD) clearance compared to chemotherapy.
Performed by the Children’s Oncology Group (COG), the trial is now closed to accrual for the high-risk and intermediate-risk group, while the low-risk arm will continue enrolment.
Adverse events in both trials were found to be consistent with Blincyto’s known safety profile.
Amgen Research and Development executive vice-president David Reese said: “Considered together, the results of these studies are remarkable. Children and adolescents who relapse with ALL face a poor prognosis and there remains a need for additional treatment options, particularly for those 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.”
Blincyto is a bispecific antibody designed to selectively bind to CD19 expressed on the surface of B cells and CD3 present on the T-cells surface.
Bispecific T-cell engager (BiTE) antibody constructs work by assisting the immune system in identifying and targeting malignant cells.