On February 15, 2024 Gilead Sciences, Inc. reported that it has paused enrollment globally in the magrolimab solid tumor studies. The U.S. Food and Drug Administration (FDA) subsequently requested a partial clinical hold on these trials (Press release, Gilead Sciences, FEB 15, 2024, View Source [SID1234640174]). This request is in addition to the previously announced full clinical hold on all magrolimab studies in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) requested by the FDA. Gilead is reviewing the benefit-risk of magrolimab across all ongoing trials and will provide an update on this assessment as soon as possible.

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Patients already enrolled in the Gilead-sponsored ELEVATE solid tumor studies and deriving clinical benefit may continue to choose receiving magrolimab following reconsenting to the study with their healthcare provider.

The Gilead-sponsored ELEVATE solid tumor studies impacted by the partial clinical hold include:

Phase 2 study in head and neck squamous cell carcinoma (NCT04854499)
Phase 2 study in solid tumors (NCT04827576)
Phase 2 study in triple-negative breast cancer (NCT04958785)
Phase 2 study in colorectal cancer (NCT05330429)
The enrollment hold also applies to Investigator Sponsored Studies with magrolimab in solid tumors.