Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)

A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome

The objective of this study to evaluate the efficacy FG-4592 for the treatment of anemia in Chinese participants with lower risk MDS.

This is a Phase 2/3 trial with sequential Phase 2 and Phase 3 components. In each part, there is an up to 4 weeks screening period followed by a treatment period of 26 weeks and a 4 week follow-up period.

Key Inclusion Criteria:

• Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts (documented within 12 weeks prior to Day 1)
• Screening Hb <10 g/dL and ≥6g/dL
• Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1
• Erythropoiesis-stimulating agent (ESA)-naïve (not within 30 days of Day 1)
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

Key Exclusion Criteria:

• Diagnosis of secondary MDS
• Significant myelofibrosis (>2+fibrosis)
• Prior therapy with azacitidine, decitabine, antithymocyte globulin, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to Day 1
• Baseline erythropoietin level of >400 units (U)/liter (L)
• Clinically significant anemia due to non-MDS etiologies

Note: Other inclusion and exclusion criteria may apply.