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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
Median Survival 9.0 Months, with a Median Follow-up of 10.7 Months
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 or complete response 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.
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. One patient had a fatal event of fungal infection that the investigator considered related to treatment.
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
In addition to the results from this study, data from studies of 12
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 endpoints included molecular response rate, duration of response and overall survival. As of
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. Blinatumomab is the first of the BiTE antibodies and
Acute lymphoblastic leukemia (ALL) is an aggressive cancer of the blood and bone marrow — the spongy tissue inside bones where blood cells are made. The disease progresses rapidly and affects immature blood cells, rather than mature ones.(1) Worldwide, ALL accounts for more than 12 percent of leukemia. Of the 42,000 people diagnosed worldwide, 31,000 will die from the disease.(2) Patients with ALL have abnormal white blood cells (lymphocytes) that crowd out healthy white blood cells, red blood cells and platelets, leading to infection, anemia (fatigue), easy bleeding and serious side effects.(3,4)
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the
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(1) Definition of Acute lymphocytic leukemia.
(2) World. Globocan 2008 website. http://globocan.iarc.fr/factsheet.asp. Accessed
(3) Causes of Acute lymphocytic leukemia.
(4) Symptoms of Acute lymphocytic leukemia.