Express | Reducing the risk of disease recurrence by 67%, Amgen's bispecific antibody therapy phase 3 clinical results released

▎Amgen, the editor of WuXi AppTec's content team, today announced a phase 3 clinical trial of bispecific antibody therapy Blincyto (blinatumomab) for the first relapse of high-risk B-cell precursor acute lymphoblastic leukemia (B-ALL) in children The results were published in the Journal of the American Medical Association (JAMA).

Compared with consolidation chemotherapy, Blincyto can significantly prolong the event-free survival of patients (events include recurrence, death, new tumors, or failure to achieve complete remission).

It is worth mentioning that 93% of patients with minimal residual disease (MRD) positive at baseline achieved MRD-negative remission after receiving Blincyto treatment.

Acute lymphocytic leukemia is the most common leukemia among children.
B-cell ALL makes children more susceptible to infections because cancerous B cells cannot perform their immune functions normally.

Although existing therapies can cure most ALL patients, once the patient relapses, the prognosis drops rapidly, especially for high-risk ALL patients.

Blincyto is a bispecific T cell adaptor (BiTE) developed by Amgen.
One end of it binds to the CD19 antigen expressed on the surface of B cells, and the other end binds to the CD3 receptor on the surface of T cells.

It can recruit T cells to the vicinity of cancer cells and promote their killing of cancer cells.

Blincyto has been approved by the FDA to treat patients with relapsed/refractory B-cell ALL.

It has also received accelerated approval from the FDA, and the treatment has entered the first or second complete remission, but minimal residual disease (MRD) is greater than 0.
1% of B-cell ALL patients.

In an open-label, randomized, global phase 3 clinical trial, children with high-risk first-time B-cell ALL were treated with Blincyto or standard consolidation chemotherapy after entering complete remission.

At a median follow-up time of 22.
4 months, 69% of patients in the Blincyto group maintained event-free survival, compared with 43% in the chemotherapy group.

In addition, after receiving Blincyto treatment, 93% of MRD-positive patients achieved MRD-negative remission at baseline, compared with 24% in the chemotherapy group.

The overall survival rate at 36 months in the Blincyto group was estimated to be 81.
1%, while that of the chemotherapy group was 55.
8%.

"Acute lymphocytic leukemia is the most common type of cancer in children.

Unfortunately, about 15% of high-risk B-ALL children will relapse after first-line chemotherapy.

" said Dr.
David M.
Reese, Executive Vice President of Amgen Research and Development .
This research result supports Blincyto as a new standard consolidation therapy for patients with this aggressive disease.

"Note: This article is intended to introduce medical health research, not a treatment plan recommendation.

If you need guidance on treatment plans, please go to a regular hospital for treatment.

Reference: [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:// 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.