Darbepoetin Alfa
Interim data suggest major response with Aranesp(R) in anemic patients with MDS
By Amgen
Jul 10, 2005, 20:17

Amgen Inc. (NASDAQ:AMGN), the world's largest biotechnology company, today announced new interim data from a Phase 2 study evaluating the use of 500 mcg of Aranesp(R) (darbepoetin alfa) every three weeks to treat anemia in patients with a bone marrow disorder known as myelodysplastic syndromes (MDS). The data were presented at the 17th International Symposium of the Multinational Association of Supportive Care in Cancer (MASCC) in Geneva. (Abstract #02-007)

"The majority of MDS patients develop clinically significant anemia during the course of their disease, which often leads to fatigue and increased red blood cell transfusions," 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. "In this study, low risk MDS patients receiving Aranesp every three weeks, who had no prior erythropoietic therapy, exhibited an overall response of 77 percent, increased hemoglobin levels and improvements in patient reported fatigue."

Results of an interim analysis were presented from the first 100 patients of an approximately 200 patient, Phase 2, single arm study of low risk MDS patients (those with a low risk of progressing to acute myeloid leukemia) with anemia and treated with Aranesp 500 mcg administered every three weeks. Of the 100 patients evaluated, 63 percent had no prior erythropoietic agent use. 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) during the 13-week test period. Secondary endpoints included changes in hemoglobin level from baseline, incidence of transfusions and impact on patient reported fatigue.

Results were presented for all 100 patients for incidence of transfusion and patient reported fatigue and 90 patients were evaluated for erythroid response and target hemoglobin. In the group who had no previous treatment with an erythropoietin (n=57), 77 percent of patients had an erythroid response with 47 percent classified as major (greater than or equal to 2 g/dL increase from baseline hemoglobin or transfusion independence). In the previously erythropoietin treated group (n=33), 36 percent experienced an erythroid response with 21 percent classified as major. Two-thirds of patients achieved hemoglobin levels above 11 g/dL, the target range for patients with chemotherapy-induced anemia. Eighteen percent in the erythropoietin-naive group had a least one transfusion during the 13-week observation period.

"In these interim results MDS patients who have never been treated for their anemia responded to Aranesp and those who had prior erythropoietic therapy continued to respond," added Gabrilove. "There are currently no recombinant erythropoietic products approved by the FDA for the treatment of anemia in MDS patients. These interim data are encouraging and we look forward to the final results."

During the 13-week test period, 74 percent of patients experienced at least one adverse event. Sixteen percent (n=16) of patients experienced a serious adverse event, with anemia, neutropenia and chest pain as the most common. Five percent (n=5) had treatment-related adverse events, with injection-site pain as the most common. No thrombotic events have been reported to date in this study.

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