Amgen Inc. (AMGN) announced updated results from a Phase 2 study that showed treatment with blinatumomab or AMG 103 helped achieve a high-rate of complete response or CR in 72 percent of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia or ALL treated in the study.
Blinatumomab is the first of a new class of agents called bi-specific T cell engagers (BiTE) antibodies, designed to harness the body's cell-destroying T cells to kill cancer cells.
Blinatumomab targets cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas, such as ALL.
In this Phase 2 single-arm dose-ranging trial, 26 of the 36 patients treated with blinatumomab across all of the tested doses and schedules achieved a CR with partial hematologic recovery (CRh). All but two patients achieved a molecular response, meaning there was no evidence of leukemic cells by polymerase chain reaction. No treatment related deaths or serious adverse events or AEs were reported in the study, the company said.
According to the company, at the time of the analysis, median survival was 9.0 (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.
For patients who received the selected dose and schedule, the most common adverse events were grade one or two and included pyrexia (70 percent), headache (39 percent), tremor (30 percent) and fatigue (30 percent).
Reversible central nervous system events led to treatment interruptions in six patients with two patients permanently discontinuing treatment. Cytokine release syndrome led to treatment interruption in two patients.
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