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Amgen's BiTE® Antibody Blinatumomab (AMG 103) Achieved High Rate of Complete Response in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Date:5/16/2012

THOUSAND OAKS, Calif., May 16, 2012 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today 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 percent of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (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. Full results of the study will be presented during an oral abstract session at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 4 (Abstract Number 6500, 8:00 a.m. - 8:15 a.m. CDT, E354a).

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 (AEs) were reported in the study.

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 these patients with limited treatment options, the remission rate observed in the trial is a vast improvement over the current standard of care," said Professor Max Topp, Department of Internal Medicine II, University of Wuerzburg and chair of the study. "These
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