Dr. Gerds on Design and Safety Analysis of a Trial With Luspatercept in Myelofibrosis

Aaron Gerds, MD, assistant professor of medicine in the Hematology and Medical Oncology Department at the Cleveland Clinic Taussig Cancer Institute, discusses the design and safety analysis of a phase II trial of luspatercept in patients with myelofibrosis-associated anemia.

In the open-label phase II trial, patients with myelofibrosis-associated anemia received luspatercept. Patients were grouped according to their exposure to ruxolitinib (Jakafi) and transfusion-dependence, says Gerds.

In addition to evaluating the activity of the agent, investigators analyzed safety. The most common adverse events (AEs) reported in the trial included elevated blood pressure, diarrhea, and bone pain, the latter of which had been reported in prior studies done in patients with beta-thalassemia and myelodysplastic syndrome. No disease-related AEs led to death, and all cases of hypertension were able to be controlled medically, concludes Gerds.