Magrolimab Plus Azacitidine Trials Placed on Partial Clinical Hold by FDA

All studies evaluating magrolimab in combination with azacitidine have been placed on partial clinical hold by the US Food and Drug Administration (FDA) following investigator reports of a discrepancy in suspected unexpected serious adverse events between treatment arms.

Magrolimab is a monoclonal antibody targeting CD47 and macrophage checkpoint inhibitor designed to hinder the recognition of CD47 through the SIRPα receptor on magrophages.

While patients who are already enrolled may continue to receive magrolimab and azacitidine under close monitoring, the screening and enrollment of new participants will be halted during the investigation.

Studies placed on clinical hold by the FDA include:

• phase III ENHANCE study in myelodysplastic syndrome (MDS; NCT04313881)
• phase III ENHANCE-2 study in acute myeloid leukemia (AML; TP53-mutated patients; NCT04778397)
• phase III ENHANCE-3 study in unfit AML (NCT05079230)
• phase Ib study in MDS (NCT03248479)
• the azacitidine combination cohorts of a phase II study in myeloid malignancies (NCT04778410)

Cohorts or trials evaluating magrolimab without azacitidine are not affected by the partial clinical hold.

Source: Gilead press release, Jan. 25, 2022.