FDA Puts Clinical Hold On Gilead's Magrolimab/Azacitidine Combo Trials In Blood Cancer Settings

The FDA has placed a partial clinical hold on Gilead Sciences Inc's GILD studies evaluating the combination of magrolimab plus azacitidine.

• Due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms, the agency has taken action.
• While no clear trend in the adverse reactions or new safety signal has been identified, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies.
• Related content: Benzinga's Full FDA Calendar.
• Screening and enrollment of new study participants will be paused during the partial clinical hold. 
• Patients already enrolled in these clinical studies may continue to receive magrolimab and azacitidine, or placebo, and continue to be closely monitored. 
• Trials that test magrolimab alone, without azacitidine, or in combination with other agents are unaffected.
• The partial hold applies to three Phase 3 studies covering myelodysplastic syndrome; AML and unfit AML (patients unable to receive intensive chemotherapy), along with earlier stage studies for MDS and myeloid malignancies. 
• Six other Phase 2 studies of magrolimab will continue as planned.
• Price Action: GILD shares are down 1.93% at $67.51 during the premarket session on the last check Wednesday.