Enhance: A randomized, double-blind, multicenter study comparing Magrolimab in combination with Azacitidine versus Azacitidine plus placebo in treatment-naïve patients with higher risk Myelodysplastic Syndrome
Principal Investigator: Muthu Veeraputhiran, M.D., MPH, FACP, Clinical Program Director, Stem Cell Transplantation and Cellular Therapy
Sponsor: Gilead Sciences
Patients with intermediate, high and very high risk Myelodysplastic Syndrome (HR-MDS) have a median overall survival of 0.8 to 3.7 years. Despite the high unmet need in this patient population, Aazacitidine (AZA) is the only approved therapy for HR-MDS which has improved overall survival in clinical trials to date. Magrolimab is a first-in-class monoclonal antibody that blocks the macrophage inhibitory immune checkpoint CD47, a “do not eat me” signal overexpressed on tumor cells. Binding of Magrolimab to CD47 leads to phagocytosis of tumor cells. AZA increases expression of prophagocytic “eat me” signals, facilitating synergy with Magrolimab. In an ongoing phase 1b study, the combination of Magrolimab + AZA led to high response rates (ORR 91%, with a CR of 42%) and an acceptable safety profile without significant immune-related adverse events.
This is a double-blind multicenter Phase 3 clinical trial with 1:1 randomization to AZA +/- Magrolimab to help treat intermediate and high risk MDS patients with an option of going to allogeneic transplant as decided by the treating hematologist. UAMS is the only center to have this trial option for MDS open in state of Arkansas.
For more information about this trial contact 501-686-8274