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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

results also represent significant progress in our research of immunotherapies; a new approach to fighting cancer that we believe could make a real difference for patients."

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). These were most frequently seen at the onset of treatment in cycle one.  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.

In addition to the results from this study, data from studies of 12 Amgen investigational molecules and marketed products will be presented at the ASCO Annual Meeting. These include results from studies of the immunotherapy talimogene laherparepvec, pipeline molecules such as rilotumumab (AMG 102) and AMG 386, and marketed products. A complete listing of Amgen abstracts of interest can be found at www.amgen.com/media/amgen_asco_2012.html. Abstracts are available online at www.asco.org.

Phase 2 Study Design
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 five or 15 micrograms per meter squared per day, ranging up to 30 micrograms for the remainder of the treatment. The primary endpoint of the study was the rate of CR/CRh*. Secondary endpoint
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SOURCE Amgen
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