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Darbepoetin Alfa Dosed Efficacy Study Results Released

May 18, 2006 -- Thousand Oaks, CA -- Amgen announced that final results of a phase 3 randomized, open-label head-to-head study evaluating 200 mcg of Aranesp (darbepoetin alfa) administered every two weeks versus 40,000 U of Epoetin alfa dosed once a week have been published in the May 20th issue of the Journal of Clinical Oncology. The study demonstrated that Aranesp dosed every two weeks resulted in similar clinical efficacy as Epoetin alfa dosed once a week in boosting hemoglobin levels and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia.

"Results of this study, the largest, randomized head-to-head comparison of darbepoetin alfa dosed every two weeks to weekly Epoetin alfa, showed that fewer injections did not compromise efficacy with respect to decreased transfusion requirements," said John Glaspy, M.D., professor, David Geffen School of Medicine, University of California at Los Angeles. "From a clinician perspective, the comparability in patient reported outcomes, including energy levels and impact on daily activities, provide further evidence that we can extend dosing intervals and represents an important potential benefit for patients and their caregivers."

In the Phase 3 head-to-head study, a total of 1,220 patients with chemotherapy-induced anemia were randomized to receive either Aranesp 200 mcg every two weeks (n=613) or Epoetin alfa 40,000 U once a week (n=607). The majority of patients in both groups achieved the target hemoglobin of greater than or equal to 11 g/dL. Both groups of patients had similar blood transfusion rates, patient reported outcomes, and safety endpoints.

The study's primary endpoint was designed to evaluate non-inferiority with respect to transfusion rate. Transfusions were similar in the two treatment groups (21 percent in the Aranesp group and 16 percent in the Epoetin alfa group) demonstrating non-inferiority of Aranesp and Epoetin alfa with respect to transfusion requirements. In addition, more than three-quarters of patients in both arms of the study achieved target hemoglobin of greater than or equal to 11 g/dL (80 percent in the Aranesp group and 86 percent in the Epoetin alfa group) and remained within the target during the study period (74 percent in the Aranesp group and 80 percent in the Epoetin alfa group). No differences were observed between the two groups for the mid-study assessment of Functional Assessment of Cancer Therapy-Fatigue (FACT-F), or for any other health-related quality of life (HRQOL) assessment, which included energy, ability to conduct daily activities and overall health.

In this study, the safety profile for both Aranesp and Epoetin alfa was consistent with the existing clinical experience for adverse events in anemic cancer patients receiving chemotherapy. No differences were observed between treatment groups with respect to overall adverse events.

About Chemotherapy-Induced Anemia
Chemotherapy can reduce the bone marrow's ability to produce red blood cells that transport oxygen from the lungs to all of the body's muscles and organs. Anemia occurs when there are too few red blood cells and the body's tissues are "starved" of oxygen, which can make a patient feel short of breath, very weak, faint and tired.

This year, an estimated 1.3 million cancer patients will undergo chemotherapy in the United States; approximately 800,000 (67 percent) will become anemic. More than half of chemotherapy patients report that fatigue, a common symptom of anemia, affects their daily lives more than any other side effect of treatment, including nausea, pain and depression.

Although anemia is one of the most common side effects of chemotherapy, it is often not recognized and frequently under-treated, despite treatments that have been available for more than a decade. In fact, approximately half of patients with a hemoglobin level less than the recommended target level of 11 to 12 g/dL in the National Comprehensive Cancer Network(R) (NCCN) guidelines for "Cancer and Treatment-Related Anemia" are never treated with erythropoietic therapy.

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, Aranesp was approved by the FDA for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. 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.

Source: Amgen

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