Receive our newsletter – data, insights and analysis delivered to you
  1. News
September 25, 2019updated 23 Dec 2019 8:29am

Amgen stops Blincyto’s Phase III paediatric ALL trials early

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).

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.

Content from our partners
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU