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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 Treatment
ATLANTA, 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.
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.
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Amgen, Thousand Oaks Kristen Davis, 805-447-4587 (media) Arvind Sood, 805-447-1060 (investors)