FDA Places Magrolimab Trials on Full Clinical Hold; AML ENHANCE-3 Trial Discontinued

The US Food and Drug Administration has placed all magrolimab studies in myelodysplastic syndromes and acute myeloid leukemia (AML) on full clinical hold, including related expanded access programs.

Furthermore, Gilead Sciences, the manufacturer of magrolimab, announced that it is discontinuing the phase III ENHANCE-3 study of magrolimab in AML.

The company reported that these actions resulted from the recommendation of an independent Data Monitoring Committee, which reviewed top-line data from a planned interim analysis of overall survival in the ENHANCE-3 trial.

Gilead said that it “will not pursue further development of magrolimab in hematologic cancers,” based on those results and data from the ENHANCE and ENHANCE-2 trials.

The company said it will be sharing a subanalyses of safety and efficacy data from the ENHANCE-3 trial with regulators.

“We are incredibly grateful to all the patients and investigators for their participation in the ENHANCE studies,” said Merdad Parsey, MD, PhD, the Chief Medical Officer at Gilead, in a press release.