Phase III MATTERHORN study of Evrenzo fails to meet primary endpoint in anaemia and myelodysplastic syndromes
FibroGen announced that , a Phase III clinical study of Evrenzo (roxadustat) for treatment of anaemia in patients with transfusion-dependent lower risk myelodysplastic syndromes (MDS) did not meet its primary efficacy endpoint. The proportion of patients who achieved red blood cell transfusion independence in the first 28 weeks was 47.5% for the roxadustat arm compared to 33.3% for placebo (p=0.217).
The adverse event profile of roxadustat that was observed in the preliminary safety analysis was generally consistent with previous findings. Safety will be further evaluated at study completion.
A total of one-hundred forty (140) patients were enrolled in MATTERHORN, a Phase III, double-blind placebo-controlled study investigating the safety and efficacy of roxadustat for treatment of anaemia in patients with lower risk transfusion-dependent myelodysplastic syndromes. The primary endpoint of the study is transfusion independence for at least 56 consecutive days during the first 28 weeks of treatment, and patients are followed for up to 52 weeks. The MATTERHORN study is sponsored and conducted by FibroGen and is part of FibroGen’s co-development collaborations with AstraZeneca and with Astellas Pharma Inc.
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