Gilead: FDA Places Partial Clinical Hold On Studies Evaluating Magrolimab - Azacitidine Combination

Gilead Sciences Inc. (GILD) said Tuesday that the U.S. Food and Drug Administration has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms.

The company said it did not identify any clear trend in the adverse reactions or new safety signal at this time. But it is implementing the partial clinical hold 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.

During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine. Patients already enrolled in the clinical studies may continue to receive magrolimab and azacitidine, or placebo, and continue to be closely monitored according to the current study protocol, Gilead said in a statement.

The company noted that other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.

The studies impacted by the partial clinical hold include: Phase 3 ENHANCE study in myelodysplastic syndrome;Phase 3 ENHANCE-2 study in acute myeloid leukemia; Phase 3 ENHANCE-3 study in unfit AML; Phase 1b study in MDS; Phase 2 study in myeloid malignancies- only the azacitidine combination cohorts.

The studies not impacted by the partial clinical hold include: phase 2 study in diffuse large B-cell lymphoma; phase 2 study in multiple myeloma; phase 2 study in head and neck squamous cell carcinoma;phase 2 study in solid tumors; phase 2 study in triple-negative breast cancer; phase 2 study in colorectal cancer, planned and not currently recruiting.

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