Interim Phase 2 Aranesp(R) Data Suggest Major Response after 27/28 Weeks of Treatment for Anemia in Patients with Myelodysplastic Syndromes (MDS)
Results of One of the Largest MDS Studies to Date Show Both Previously Treated and ESA-Naive Patients Responded to Aranesp TreatmentATLANTA, Jun 03, 2006 (BUSINESS WIRE) -- Amgen (NASDAQ:AMGN), the world's largest biotechnology company,
today announced that after 27/28 weeks of treatment with Aranesp(R)
(darbepoetin alfa) administered every three weeks, patients with
low-risk myelodysplastic syndromes who had not previously received an
erythropoiesis-stimulating agent (ESA) showed a major response of 59
percent, increased hemoglobin levels and improvements in
patient-reported fatigue. These updated interim data were presented at
the 42nd Annual Meeting of the American Society of Clinical Oncology
(ASCO) in Atlanta. (Abstract #6564)
Myelodysplastic Syndromes (MDS), also known as pre-leukemia or
"smoldering" leukemia, encompass a group of disorders in which the
bone marrow does not produce enough blood cells. MDS are associated
with abnormal blood counts or poorly functioning blood cells and often
result in anemia (low red blood cell count), neutropenia (low white
blood cell count) and thrombocytopenia (low blood platelet count).
Approximately 21,000 new cases of MDS are diagnosed each year in the
United States. MDS are more prevalent in men and Caucasians and
primarily occur in people older than 60.
"These results, from one of the largest MDS studies to date, are
consistent with those observed at 13 weeks and provide evidence for
the potential use of every-three-week dosing of Aranesp in MDS
patients to reach target hemoglobin, reduce the need for blood
transfusions and improve patient reported outcomes," said Janice
Gabrilove, M.D., professor of Medicine, Hematology and Medical
Oncology at Mount Sinai School of Medicine, New York, and the study's
lead investigator.
Interim (27/28-week) results from the fully enrolled study were
presented for 206 of 209 low- or intermediate-risk MDS patients with
anemia (Hb less than or equal to 11 g/dL) and included erythroid
response, achievement of target hemoglobin, incidence of transfusion,
and patient reported fatigue. Sixty-nine percent of these patients
(n=142) had not previously received an ESA.
In the group that had not previously received an ESA, 74 percent
of patients had an erythroid response, with 59 percent classified as
major response (greater than or equal to 2 g/dL increase in hemoglobin
from baseline or transfusion independence). In addition, 74 percent of
patients achieved the target hemoglobin level of 11 g/dL and no
patients required a transfusion during the 27/28-week observation
period.
In the group previously treated with an ESA (n=64), 50 percent
experienced an erythroid response, with 30 percent classified as
major. Additionally, 49 percent of patients achieved the target
hemoglobin level of 11 g/dL and five percent received at least one
transfusion during the 27/28-week observation period.
During the 27/28-week test period, treatment-related adverse
events were reported in nine percent of patients in the group not
previously treated with an ESA and in six percent of patients in the
group previously treated with an ESA. Three thromboembolic events have
been reported to date in this study. No pulmonary emboli have been
reported.
Exploratory Analysis of Baseline Predictors of Response
Additional results of an exploratory analysis following 27/28
weeks of treatment suggest that patients not previously treated with
an ESA, and baseline endogenous erythropoietin (eEPO) levels and
distinct FAB (French-American-British cooperative group criteria)
tissue subtypes may help predict which patients will respond to
treatment with an ESA. (Abstract #6579)
"This exploratory analysis suggests that patients with lower
baseline endogenous erythropoietin levels and those with refractory
anemia may be more likely to achieve a major response with Aranesp
treatment," said Dr. Gabrilove.
About the Phase 2 Study
This ongoing, Phase 2, single-arm, open-label, 52-week study of
209 low-risk MDS patients (those with a low risk of progressing to
acute myeloid leukemia) was designed to evaluate treatment of anemia
in this patient population with Aranesp (500 mcg) administered every
three weeks. The primary endpoint of the study was the proportion of
patients achieving an erythroid response (defined in accordance with
the International Working Group Response Criteria) by week 13.
Secondary endpoints included proportion of patients achieving an
erythroid response by 27/28 weeks, changes in hemoglobin level from
baseline, incidence of transfusions and impact on patient reported
fatigue.
About Aranesp
Amgen revolutionized anemia treatment with the development of
Epoetin alfa, a recombinant erythropoietin (a protein that stimulates
the production of oxygen-carrying red blood cells). Building on this
heritage, Amgen developed Aranesp, a unique erythropoiesis-stimulating
protein that can be dosed less frequently.
Aranesp was approved by the U.S. Food and Drug Administration
(FDA) in September 2001 for the treatment of anemia associated with
chronic renal failure (CRF), also known as chronic kidney disease
(CKD), for patients on dialysis and patients not on dialysis. In July
2002, the FDA approved weekly dosing of Aranesp for the treatment of
chemotherapy-induced anemia in patients with nonmyeloid malignancies
and in March 2006, the FDA approved every-three-week dosing in these
patients. With the addition of the every-three-week dosing, Aranesp,
the only erythropoiesis-stimulating protein approved by the FDA for
every-three-week administration, can allow physicians to synchronize
anemia treatment with weekly and every-three-week chemotherapy, which
are the majority of chemotherapy schedules. Since its introduction in
2001, more than 1.7 million CKD and chemotherapy patients with anemia
have received treatment with Aranesp.
Important Safety Information
Aranesp is contraindicated in patients with uncontrolled
hypertension. Erythropoietic therapies may increase the risk of
thrombotic events and other serious events. The target hemoglobin (Hb)
should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in any
2-week period, dose reductions are recommended. In a study with
another erythropoietic product, where the target Hb was 12-14 g/dL, an
increased incidence of thrombotic events, disease progression, and
mortality was seen.
Cases of pure red cell aplasia (PRCA) and of severe anemia, with
or without other cytopenias associated with neutralizing antibodies to
erythropoietin have been reported in patients treated with Aranesp.
This has been reported predominately in patients with CRF receiving
Aranesp by subcutaneous administration. A sudden loss of response to
Aranesp, accompanied by severe anemia and low reticulocyte count,
should be evaluated. If anti-erythropoietin antibody-associated anemia
is suspected, withhold Aranesp and other erythropoietic proteins.
Aranesp should be permanently discontinued in patients with
antibody-mediated anemia. Patients should not be switched to other
erythropoietic proteins.
The most commonly reported side effects in clinical trials were
fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.
About Amgen
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
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Amgen therapeutics have changed the practice of medicine, helping
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With a broad and deep pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve
people's lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
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Aranesp prescribing information can be accessed by calling
800-772-6436 or by logging on to www.aranesp.com.
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SOURCE: Amgen
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Kristen Davis, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)