Drugs

Gilead Partial Clinical Hold on Magrolimab Trials

FDA has placed a partial clinical hold on Gilead Sciences’ studies evaluating the combination of magrolimab plus azacitidine (Celgene’s Vidaza) due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms. “While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA,” the company says.

Under the hold, new study participant screening and enrollment will be paused in any study investigating the combination of magrolimab with azacitidine, Gilead says. Patients already enrolled in these clinical studies may continue to receive treatment under current study protocols. Studies affected by the partial hold are:

Phase 3 ENHANCE study in myelodysplastic syndrome (MDS; NCT04313881)
Phase 3 ENHANCE-2 study in acute myeloid leukemia (AML; TP53 mutated patients; NCT04778397)
Phase 3 ENHANCE-3 study in unfit AML (NCT05079230)
Phase 1b study in MDS (NCT03248479)
Phase 2 study in myeloid malignancies (NCT04778410) *only the azacitidine combination cohorts

Gilead describes magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers and solid tumor malignancies.

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