Amgen announced updated results from a Phase 2 study that showed treatmentwith blinatumomab (AMG 103) helped achieve a high-rate of complete response(CR) in 72% of adult patients with relapsed or refractory B-precursor acutelymphoblastic leukemia (ALL) treated in the study.
This Phase 2 dose-ranging study evaluated the efficacy, safety andtolerability of blinatumomab in adult patients with B-precursor ALL who hadrelapsed following treatment with standard front-line chemotherapy orallogeneic stem cell transplant. Patients received blinatumomab for 28 daysfollowed by two weeks off therapy over a six week treatment cycle, for up tofive treatment cycles. Patients received a continuous intravenous infusion ofblinatumomab at an initial dose of 5 or 15mcg/m2/day, ranging up to 30mcg forthe remainder of the treatment. The primary endpoint of the study was the rateof CR/CR with partial hematologic recovery (CRh*). Secondary endpoints includedmolecular response rate, duration of response and overall survival.
In this single-arm dose-ranging trial, 26 of the 36 patients treated withblinatumomab across all of the tested doses and schedules achieved CRh*. Allbut two patients achieved a molecular response, meaning there was no evidenceof leukemic cells by polymerase chain reaction.
At the time of the analysis, median survival was 9 (8.2, 15.8) months with amedian follow-up period of 10.7 months. In the group of patients who receivedthe selected dose, median survival was 8.5 months. The median duration ofresponse in the 26 patients who responded to treatment was 8.9 months.
Blinatumomab (AMG 103) is a bispecific T cellengager (BiTE) antibody designed to direct the body’s cell-destroying T cellsagainst target cells expressing CD19, a protein found on the surface of B-cellderived leukemias and lymphomas. The modified antibodies are designed to engagetwo different targets simultaneously, thereby juxtaposing T cells to cancercells.
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