ASH Clinical News January 2016 | Page 43

CLINICAL NEWS Luspatercept Leads to Increased Hemoglobin Levels, Transfusion Independence in MDS Patients Treatment with luspatercept, an investigational fusion protein for the treatment of anemias with ineffective red blood cell (RBC) production, was associated with increased hemoglobin counts and greater rates of transfusion-independence in patients with lower-risk myelodysplastic syndromes (MDS), according to preliminary data from the phase II PACE-MDS extension study. “MDS patients have increase Smad2/3 signaling in the bone marrow, leading to ineffective erythropoiesis,” lead author Aristoteles Giagounidis, MD, PhD, head of the Department of Oncology, Hematology, and Palliative Care at Marien Hospital in Düsseldorf, Germany, explained in his presentation during the 2015 ASH Annual Meeting in Orlando, Florida. “Luspatercept inhibits Smad2/3 signaling and promotes late-stage erythroid differentiation, thereby correcting the ineffective erythropoiesis.” Luspatercept contains a modified activin receptor B, fused to a human IgG Fc domain. The activin receptor is responsible for blockade of TGF-b superfamily ligands, which in turn inhibits Smad2/3 signaling. Dr. Giagounidis reported results from the 24-month extension of the phase II, multi-center, open-label PACE-MDS study, which evaluated the longer-term effects of luspatercept on anemia in 32 patients with lower-risk MDS (IPSS classification of low/int-1). In the PACE-MDS base study, patients were eligible for inclusion if they were ≥18 years old, had anemia with high or low transfusion burden and hemoglobin <10.0 g/dL, and were non-responsive or refractory to erythropoiesis-stimulating