Phase 2 Study Update of Blinatumomab (AMG 103) for Relapsed or Refractory Acute Lymphoblastic Leukemia

Amgen announced updated results from a Phase 2 study that showed treatment with blinatumomab (AMG 103) helped achieve a high-rate of complete response (CR) in 72% of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) treated in the study.

This Phase 2 dose-ranging study evaluated the efficacy, safety and tolerability of blinatumomab in adult patients with B-precursor ALL who had relapsed following treatment with standard front-line chemotherapy or allogeneic stem cell transplant. Patients received blinatumomab for 28 days followed by two weeks off therapy over a six week treatment cycle, for up to five treatment cycles. Patients received a continuous intravenous infusion of blinatumomab at an initial dose of 5 or 15mcg/m2/day, ranging up to 30mcg for the remainder of the treatment. The primary endpoint of the study was the rate of CR/CR with partial hematologic recovery (CRh*). Secondary endpoints included molecular response rate, duration of response and overall survival.

In this single-arm dose-ranging trial, 26 of the 36 patients treated with blinatumomab across all of the tested doses and schedules achieved CRh*. All but two patients achieved a molecular response, meaning there was no evidence of leukemic cells by polymerase chain reaction.

At the time of the analysis, median survival was 9 (8.2, 15.8) months with a median follow-up period of 10.7 months. In the group of patients who received the selected dose, median survival was 8.5 months. The median duration of response in the 26 patients who responded to treatment was 8.9 months.

Blinatumomab (AMG 103) is a bispecific T cell engager (BiTE) antibody designed to direct the body's cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells to cancer cells.

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