Amgen's Blincyto Reduces Risk of Disease Relapse by 67% in Phase 3 Trial for Pediatric B-ALL

Amgen Announces Publication of Phase 3 Trial Results for Blincyto (blinatumomab) in Pediatric Patients with High-Risk First-Relapse B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL) in JAMAAmgen announced today that the results of a Phase 3 clinical trial evaluating the bispecific antibody therapy Blincyto (blinatumomab) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) have been published in the Journal of the American Medical Association (JAMA). Compared with consolidation chemotherapy, Blincyto significantly prolonged event-free survival in patients (events included relapse, death, emergence of new malignancies, or failure to achieve complete remission). Notably, among patients who were minimal residual disease (MRD)-positive at baseline, 93% achieved MRD-negative remission following treatment with Blincyto.

Acute lymphoblastic leukemia (ALL) is the most common leukemia in children. B-cell ALL predisposes children to infections because the malignant B cells fail to perform their normal immune functions. Although current therapies can cure the majority of patients with ALL, prognosis deteriorates rapidly upon relapse, particularly among those with high-risk disease.

Blincyto is a bispecific T-cell engager (BiTE) developed by Amgen. One end binds to the CD19 antigen expressed on the surface of B cells, while the other end binds to the CD3 receptor on the surface of T cells. It recruits T cells to the vicinity of cancer cells, thereby enhancing their cytotoxic activity against these cells. Blincyto has received FDA approval for the treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It has also received accelerated approval from the FDA for the treatment of patients with B-cell precursor ALL who are in first or second complete remission but have minimal residual disease (MRD) greater than 0.1%.

In an open-label, randomized, global Phase 3 clinical trial, pediatric patients with high-risk first-relapse B-cell acute lymphoblastic leukemia (ALL) received treatment with Blincyto or standard consolidation chemotherapy after achieving complete remission. At a median follow-up of 22.4 months, 69% of patients in the Blincyto group maintained event-free survival, compared to 43% in the chemotherapy group. Furthermore, among patients who were minimal residual disease (MRD)-positive at baseline, 93% achieved MRD-negative remission following treatment with Blincyto, versus 24% in the chemotherapy group.

The estimated overall survival rate at 36 months was 81.1% in the Blincyto group, compared with 55.8% in the chemotherapy group.

“Acute lymphoblastic leukemia is the most common type of cancer in children. Unfortunately, approximately 15% of children with high-risk B-cell precursor acute lymphoblastic leukemia (B-ALL) experience relapse after first-line chemotherapy,” said Dr. David M. Reese, Executive Vice President of Research and Development at Amgen. “These findings support Blincyto as a new standard consolidation therapy for patients with this aggressive disease.”

References:

[1] BLINCYTO® (Blinatumomab) Demonstrated Significantly Prolonged Event-Free Survival Compared With Consolidation Chemotherapy In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia. Retrieved March 2, 2021, from https://www.prnewswire.com/news-releases/blincyto-blinatumomab-demonstrated-significantly-prolonged-event-free-survival-compared-with-consolidation-chemotherapy-in-pediatric-patients-with-relapsed-acute-lymphoblastic-leukemia-301238918.html

[2] Locatelli et al., (2021). Effect of Blinatumomab vs Chemotherapy on Event-Free Survival Among Children With High-risk First-Relapse B-Cell Acute Lymphoblastic Leukemia. JAMA, doi:10.1001/jama.2021.0987.

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