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Darbepoetin Alfa (Aranesp) Data Suggests Major Response in Anemic Patients With Myelodysplastic Syndrome: Presented at ASH

By Bruce Sylvester

ATLANTA, GA -- December 16, 2005 -- Interim results from a phase 2, open-label study indicate that darbepoetin alfa (Aranesp) 500 mcg taken Q3W appears to be well tolerated and capable of increasing hemoglobin (Hb) levels in patients with myelodysplastic syndrome (MDS).

Dr. Janice Gabrilove, MD, professor of medicine, Mount Sinai School of Medicine, New York, New York, presented 13-week results for 189 out of 209 enrolled subjects. The results included erythroid response, achievement of target hemoglobin, incidence of transfusion, and reported fatigue.

The results were presented here on December 11^th at the 47^th Annual Meeting of the American Society of Hematology (ASH).

Of the 189 subjects, 130 had not previously used an erythropoietin drug. Of those who had had no prior erythropoietic treatment, 70% achieved an erythropoietin response, and 49% of these had a major response, defined as a 2-g/dL or more increase from baseline hemoglobin or transfusion independence.

Results show that 67% of evaluable subjects achieved the target hemoglobin of 11 g/dL, and 19% in the erythropoietin-naive group received at least 1 transfusion during the 13 weeks of observation.

In the 59 patients previously treated with erythropoietin, 44% achieved an erythroid response, and 24% a major response. Of this group, 45% achieved a target hemoglobin level of 11 g/dL, and 29% had at least 1 transfusion.

"Since most MDS patients develop significant anemia during their disease and since there are now no approved recombinant erythropoietin drugs for treating anemia in MDS patients, these results are encouraging," Dr. Gabrilove said.

The study was supported by Amgen.


[Presentation title: A Phase 2, Single-Arm, Open-Label Trial To Evaluate the Effectiveness of Darbepoetin alfa for the Treatment of Anemia in Patients With Low-Risk Myelodysplastic Syndrome. 2541]

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