The U.S. Food and Drug Administration (FDA) approved Blincyto for the treatment of adults and children with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) and Philadelphia chromosome-positive ALL patients. These diseases are characterized by too many immune B-cell lymphoblasts that grow out of control and become malignant.
How Blincyto works
Blincyto is a so-called CD19-directed, CD3 T-cell engager antibody, meaning that it binds to a molecule called CD19 that is found on the surface of malignant immune B-cells, as well as to a protein called CD3 that is found on the surface of other immune cells, called T-cells. The result is that it brings together T-cells and malignant B-cells, helping the T-cells to recognize and target the malignant B-cells, leading to their destruction.
Blincyto in clinical trials
FDA approval of Blincyto was based on the results of two clinical trials.
The first was an open-label, Phase 3 trial (NCT02013167) in 405 patients with relapsed or refractory B-cell precursor ALL. The trial, called TOWER, compared Blincyto to standard-of-care chemotherapy and showed a statistically significant improvement in overall survival in patients treated with Blincyto compared to those treated with chemotherapy (7.7 months versus 4 months, respectively). Remission rates within 12 weeks after the start of treatment also were significantly higher in the Blincyto-treated group compared to the chemotherapy-treated group. The results were published in The New England Journal of Medicine.
The second trial was a Phase 2 study (NCT02000427), called ALCANTARA, designed to evaluate the rate of remission induced by Blincyto in 45 patients with relapsed/refractory Philadelphia chromosome-positive (Ph+) B-precursor ALL. The results of the study, published in the Journal of Clinical Oncology, demonstrated that 36 percent of the patients achieved a complete remission with complete or partial hematological recovery for a median of 6.7 months. The study was completed in 2017.
In addition to adults, Blincyto was evaluated for the treatment of children with relapsed/refractory B-cell precursor ALL in a Phase 1/2 trial (NCT01471782). The Phase 1 portion was a dose-escalation study in 49 patients, and the Phase 2 portion was a six-week treatment study in 44 patients. Results published in the Journal of Clinical Oncology showed that among the 70 patients who received the recommended dosage, 27 (39 percent) achieved complete remission in the first two cycles of treatment, of whom 14 (52 percent) achieved complete minimal residual disease response, or a small number of leukemic cells remaining.
Amgen is planning to further evaluate Blincyto in 13 studies that are currently recruiting participants, or that will begin recruiting in the future.
The most common adverse events caused by Blincyto include fever, headache, and low concentration of certain white blood cells in the blood. Amgen also reported the occurrence of a number of serious adverse events in patients treated with Blincyto.
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