Final Phase 2 Data Continue to Show Promising Results after One Year of Aranesp(R) Treatment for Anemia in Patients with Myelodysplastic Syndromes (MDS)
Aranesp Treatment Appears to Improve Hemoglobin Levels in One of the Largest MDS Studies to Date
ORLANDO, Fla.--(BUSINESS WIRE)--Dec. 10, 2006--Amgen (NASDAQ: AMGN) today announced that after 53/55 weeks of treatment with Aranesp(R) (darbepoetin alfa) administered every three weeks, 74 percent of anemic patients with low- or intermediate-risk myelodysplastic syndromes who had not previously received an erythropoiesis-stimulating agent (ESA) had an erythroid response, with 59 percent classified as major response. These final data were presented at the American Society of Hematology (ASH) 48th Annual Meeting in Orlando, Fla. (Abstract # 2671)
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.
"It is encouraging that these results are consistent with those observed at 27/28 weeks, and that patients are continuing to respond after one year of therapy," 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. "This updated analysis provides further evidence for the potential use of Aranesp in MDS patients to improve hemoglobin levels, reduce the need for blood transfusions and improve patient-reported outcomes. These data also suggest the potential for an every-three-week dosing schedule for patients with infrequent clinic visits."
Final (53/55-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. Seventy percent of these patients (n=144) had not previously received an ESA.
In the group that had not previously received an ESA, 74 percent of patients showed an erythroid response, with 59 percent classified as having a major response (greater than or equal to 2 g/dL increase in hemoglobin from baseline or transfusion independence). In addition, 82 percent of patients achieved the target hemoglobin level of 11 g/dL.
In the group previously treated with an ESA (n=62), 50 percent experienced an erythroid response, with 34 percent classified as major. Additionally, 55 percent of patients achieved the target hemoglobin level of 11 g/dL.
During the 53/55-week test period, treatment-related adverse events were reported in 11 percent of patients in the group not previously treated with an ESA and in 8 percent of patients in the group previously treated with an ESA. Two thromboembolic events in the Aranesp group have been reported to date in this study.
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 is the proportion of patients achieving an erythroid response (defined in accordance with the International Working Group Response Criteria) by week 13. Secondary endpoints include proportion of patients achieving an erythroid response by 53/55 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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