Amgen has reported positive data from the Phase III study of BLINCYTO (blinatumomab) in paediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukaemia (B-ALL).
A bispecific T-cell engager (BiTE) immuno-oncology therapy, BLINCYTO targets CD19 surface antigens on B cells.
By helping the body’s immune system in identifying and targeting malignant cells by engaging T cells to cancer cells, BiTE molecules help fight cancer.
The open-label, multi-centre, randomised, controlled study analysed the efficacy, safety and tolerability of BLINCYTO versus consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in paediatric subjects.
The enrolment to the study was stopped in September 2019 owing to encouraging efficacy in the BLINCYTO arm as well as the Independent Data Monitoring Committee (DMC) recommendation.
According to data from the study, BLINCYTO showed significantly prolonged event-free survival versus chemotherapy.
Events were defined by relapse, death, second malignancy, or failure to achieve complete remission.
About 69% of patients in the BLINCYTO arm were alive and event-free versus 43% of patients receiving chemotherapy, after a median of 22.4-month follow up.
Furthermore, 93% of the BLINCYTO treated patients with Minimal Residual Disease (MRD) at baseline had MRD negative remission versus 24% in the chemotherapy group.
The 36-month overall survival (OS) estimate in the BLINCYTO arm was 81.1% as compared with 55.8% in the chemotherapy arm, while the median OS was not met.
Incidence of serious adverse events (AEs) was 24.1% versus 43.1% in BLINCYTO arm versus chemotherapy arm, respectively,
Amgen Research and Development executive vice-president David Reese said: “Acute lymphoblastic leukaemia is the most common type of cancer in children. Unfortunately, approximately 15% of children with high-risk B-ALL relapse after frontline chemotherapy.
“There remains an urgent need for novel treatment options for these patients, and the study results support BLINCYTO as a new standard of care consolidation therapy for patients with this aggressive disease.”