Interim Data Suggest Potential Benefits of Darbepoetin Dosed Every 3 Weeks With Intravenous Iron

Amgen announced interim phase III data suggesting darbepoetin alfa (Aranesp) administered every 3 weeks with intravenous (IV) iron has the potential to further enhance the effectiveness of increasing patient hemoglobin levels to the recommended target of greater than or equal to 11 g/dL and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The data were presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta.

Synchronized Treatment

"Every-3-week dosing of Aranesp has demonstrated effectiveness in managing chemotherapy-induced anemia and allows physicians to synchronize anemia treatment and chemotherapy, offering improved patient convenience," said study investigator Johan Vansteenkiste, MD, PHD, respiratory oncology unit, University Hospital Gasthuisberg, Belgium. "The results of this study suggest that Aranesp administered every 3 weeks in combination with intravenous iron may help maximize the proportion of patients reaching target hemoglobin levels."

Interim results from 196 patients in this phase IIIb study demonstrated that, among patients receiving 500 µg darbepoetin administered every 3 weeks in combination with IV iron (n = 100), 94% achieved the target hemoglobin level ≥ 11 g/dL between week 5 and the end of treatment. In the group of patients who received darbepoetin and iron administered according to standard practice (oral iron or no iron, n = 96), 89% achieved the target hemoglobin level. Fewer patients in the group administered IV iron received a red blood cell transfusion between week 5 and the end of treatment compared to patients in the group receiving standard iron administration (12% vs 25%).

The safety profile for patients receiving darbepoetin administered with IV iron appeared to be comparable to patients receiving darbepoetin administered with either oral iron or no iron. Treatment-related adverse events were similar between the two groups (6% in the IV iron group compared to 3% in the oral or no iron group) and were consistent with the adverse event profile for this population of anemic chemotherapy patients receiving darbepoetin. Cardiovascular and thromboembolic adverse events were reported in few patients (six patients in each group) and were not associated with increases in hemoglobin levels.

About the Phase IIIb Study

This randomized, multicenter, open-label, 16-week study of 400 patients with chemotherapy-induced anemia is being conducted in Europe. The study is designed to evaluate the safety and efficacy of 500 µg of darbepoetin administered every 3 weeks with either IV iron (200 µg administered either every 3 weeks on the same schedule as darbepoetin or, if required, as two doses [200 µg total] within a 3-week period) or iron administered according to standard practice. Study endpoints include changes in hemoglobin level from baseline, incidence of transfusions, and incidence of adverse events and serious adverse events, in particular thromboembolic events.