Amgen's Bispecific Antibody Blincyto Demonstrates Superior Efficacy Over Chemotherapy in Phase 3 Trials, Leading to Early Termination of Patient Enrollment

Today, Amgen announced that patient enrollment in two Phase 3 trials of its bispecific antibody Blincyto (blinatumomab) for the treatment of pediatric patients with high-risk B-cell acute lymphoblastic leukemia (ALL) at first relapse was terminated early due to the drug’s significantly superior efficacy compared with the chemotherapy control group. Blincyto is the first approved bispecific T-cell engager (BiTE).

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 existing therapies can cure the majority of ALL patients, prognosis deteriorates rapidly upon relapse, particularly in patients with high-risk ALL.

Blincyto is a 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 the open-label, randomized, global Phase 3 trial designated as 20120215, pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (ALL) received treatment with Blincyto or standard consolidation chemotherapy. The primary endpoint of the trial was event-free survival. The trial results demonstrated that Blincyto met the primary endpoint. Based on the recommendation of the independent Data Monitoring Committee (DMC), Amgen prematurely terminated patient enrollment in this trial, while subsequent follow-up will continue in accordance with the trial protocol.

Furthermore, in the randomized Phase 3 clinical trial named AALL1331, Amgen will halt enrollment of pediatric patients with high-risk and intermediate-risk first-relapse B-cell acute lymphoblastic leukemia (ALL), as recommended by the Data Monitoring Committee (DMC). The DMC’s recommendation is based on significant trends demonstrated by Blincyto compared with chemotherapy in improving disease-free survival, overall survival, minimal residual disease (MRD) outcomes, and toxicity profiles.

“Overall, these results are exceptional. Children and adolescents with ALL have a poor prognosis after relapse. They still need more treatment options, especially high-risk patients,” said Dr. David M. Reese, Executive Vice President of Research and Development at Amgen. “We look forward to discussing these data with regulatory authorities.”

References:

[1] Amgen Announces Positive Results From Two Phase 3 BLINCYTO® (blinatumomab) Studies In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia. Retrieved September 24, 2019, from https://www.amgen.com/media/news-releases/2019/09/amgen-announces-positive-results-from-two-phase-3-blincyto-blinatumomab-studies-in-pediatric-patients-with-relapsed-acute-lymphoblastic-leukemia/

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