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|New Phase 2 Data Show Promise of Aranesp(R) Treatment for Anemia of Cancer|
Monthly Aranesp Treatment Improved Hematopoietic Response In Cancer Patients Not Receiving Chemotherapy or Radiation Therapy
ORLANDO, Fla.--(BUSINESS WIRE)--Dec. 9, 2006--Amgen (NASDAQ:AMGN) today announced final results of a 17-week randomized, double-blind, placebo-controlled, Phase 2 study evaluating Aranesp(R) (darbepoetin alfa) administered every four weeks for the treatment of anemia in cancer patients not undergoing chemotherapy and/or myelosuppressive radiotherapy, a condition known as anemia of cancer. Patients receiving Aranesp were nearly three times more likely to achieve a hematopoietic response than patients receiving a placebo (69 percent vs. 24 percent, respectively). These results were presented at the American Society of Hematology (ASH) 48th annual meeting in Orlando, Fla. (Abstract # 1304)
Although anemia is increasingly recognized as the most common side effect of chemotherapy, a growing body of evidence demonstrates that as many as 475,000 cancer patients also can become vulnerable to anemia due to the cancer itself. To combat anemia symptoms, anemia of cancer patients often receive a blood transfusion, which can be a tiring and invasive procedure. Despite its prevalence, anemia of cancer in patients is under-recognized and often not treated.
"Patients with cancer who are not receiving chemotherapy or myelosuppressive radiotherapy may have infrequent clinic visits," said David H. Gordon, M.D., clinical professor, University of Texas Health Science, and the study's lead investigator. "This study evaluated the effectiveness of extended dosing and the results suggest that this may be a potential treatment option for such patients."
Researchers reported results for 218 patients treated with Aranesp (n=162) or placebo (n=56) for up to 17 weeks. The study's primary endpoint was the percentage of patients with a hematopoietic response (greater than or equal to 2g/dL hemoglobin rise from baseline or achievement of hemoglobin greater than or equal to 12g/dL without a red blood cell transfusion during the preceding 28 days). Sixty-nine percent of Aranesp-treated patients had a hematopoietic response versus 24 percent in the placebo group (p less than 0.0001). In addition, 85 percent of the patients in the Aranesp group reached the target hemoglobin of greater than or equal to 11g/dL compared to 50 percent of the placebo group (p less than 0.001). Additionally, patients with hemoglobin levels less than 10 g/dL and who were treated with Aranesp received fewer red blood cell transfusions versus those patients with hemoglobin levels less than 10g/dL in the placebo group (15 percent vs. 29 percent, respectively).
The number and type of adverse events were consistent with those previously observed in patients receiving Aranesp. Four patients (2 percent) in the Aranesp arm experienced serious thromboembolic events.
About the Phase 2 Study
This randomized, double-blind, placebo-controlled, Phase 2 study assessed the efficacy of Aranesp administered every four weeks to anemia of cancer patients not undergoing chemotherapy and/or myelosuppressive radiotherapy within 30 days of screening or during the study. Eligible patients had been diagnosed with anemia of cancer (hemoglobin levels less than 11g/dL) and non-myeloid malignancy. The primary tumor types of the patients included in the study were breast, hematologic, and prostate. Patients were randomized 3:1 to Aranesp (6.75 mcg/kg) or placebo.
About Anemia of Cancer
Anemia is a serious and under-treated condition characterized by a reduction in the normal volume of red blood cells in the blood. Major symptoms of anemia include: extreme fatigue, weakness, shortness of breath, confusion, dizziness, rapid heartbeat, extreme skin pallor, difficulty staying warm and depression. Currently, there are no U.S. Food and Drug Administration (FDA)-approved treatments for chronic anemia of cancer, which is caused by the cancer itself and is unrelated to chemotherapy.
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.
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad 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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