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.
"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 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."
Explanation of Immunotherapy for Fighting Cancer
Phase 2 Study DesignThis 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 April 13, 2012, all 36 patients were evaluable for efficacy and
safety.
About BlinatumomabBlinatumomab (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 Amgen has received orphan drug designation from the
U.S. Food and Drug Administration for the treatment of ALL, chronic
lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia
and indolent B cell lymphoma and from the European Medicines Agency for
the treatment of indolent B cell lymphoma, ALL, CLL and mantle cell
leukemia (MCL).
About ALLAcute 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)
ww.marketwatch.com/story/amgens-bite-antibody-blinatumomab-amg-103-achieved-high-rate-of-complete-response-in-adult-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukemia-2012-05-16
cute
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)
Source: PR Newswire (http://s.tt/1c3FP)
cute
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)
Source: PR Newswire (http://s.tt/1c3FP)
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)
Source: PR Newswire (http://s.tt/1c3FP)
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)
Source: PR Newswire (http://s.tt/1c3FP)
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