Multicenter phase 3 trial of roxadustat for anemia in patients receiving chemotherapy for non-myeloid malignancies

A phase 3 trial at 44 centers in China evaluated the HIF prolyl hydroxylase inhibitor roxadustat for chemotherapy-induced anemia in patients with nonmyeloid malignancies. Patients were randomized to oral roxadustat or subcutaneous recombinant human erythropoetin-α (rHuEPO-α) three times a week for 12 weeks. Primary end point was change in hemoglobin concentration from baseline to week 9-13. For this end point, roxadustat was noninferior to rHuEPO-α. Noninferiority was supported by five of six secondary end points. Rates of adverse events were generally comparable between treatments. The authors conclude that roxadustat was noninferior to rHuEPOA-α in treating CIA in patients with nonmyeloid maligancies. The oral formulation of roxadustat may potentially increase compliance.