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Gilead drops blood cancer candidate after high mortality risk
GILD -4.25%Feb. 07, 2024 3:17 PM ET14

Gilead (NASDAQ:GILD) has decided to discontinue further studies on its anti-CD47 immunotherapy candidate magrolimab in blood cancer after a Phase 3 trial indicated an increased risk of death, the company announced Wednesday.

The Foster City, California-based biotech also disclosed that the FDA placed all magrolimab studies in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) under full clinical hold.

The decision follows early findings from its Phase 3 ENHANCE-3 study for magrolimab in AML and the ENHANCE and ENHANCE-2 trials in MDS and AML, respectively.

Citing an analysis of an independent panel, the company said magrolimab as a combination therapy failed in ENHANCE-3 and raised mortality risk in patients mainly due to infections and respiratory failure.

ENHANCE and ENHANCE-2 also indicated similar results with futility and an increased risk of death in the on-drug arm, Gilead (GILD) noted.

Its ongoing solid tumor programs for magrolimab are also under review for safety, and the company expects to provide an update from that assessment in the near term.

Gilead (GILD) added magrolimab with its $4.9B acquisition of cancer drug developer Forty Seven in 2020.

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