Phase III ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS to be Discontinued

The phase III ENHANCE study, which evaluated magrolimab in patients with higher-risk myelodysplastic syndromes (MDS), has been “discontinued due to futility based on a planned analysis,” according to an announcement from Gilead Sciences, Inc, the manufacturer of the drug.

Due to this, the company recommends discontinuing magrolimab treatment in patients with MDS. However, the safety data seen in this “study is consistent with the known magrolimab profile and adverse events that are typical in this patient population,” officials said.

Magrolimab is a potential first-in-class, anti-CD47 immunotherapy. It is under study in ongoing trials for solid tumors. It is also under evaluation in two pivotal trials, the ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations, and the ENHANCE-3 trial in first-line, unfit AML.

The company is working with study investigators to determine the next steps for patients enrolled in the ENHANCE study and data will be submitted to an upcoming medical meeting, according to officials.

Source: BusinessWire, July 2023