Gilead Sciences (NASDAQ:GILD) said on Thursday that enrollments to test its cancer drug, magrolimab, on solid tumors has been paused globally after data indicated an increased risk of death.
The move comes a week after the U.S. Food and Drug Administration (FDA) requested a partial clinical hold on these trials.
This request was 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 U.S. regulator.
The decision followed early findings from a 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. Similar results were observed in the other two trials, with futility and an increased risk of death in the on-drug arm.
Gilead (GILD) added magrolimab with its $4.9B acquisition of cancer drug developer Forty Seven in 2020.
The Foster City, California-based biotech is reviewing the benefit-risk of magrolimab across all ongoing trials and will provide an update on this assessment as soon as possible, it said.
Patients already enrolled in the Gilead-sponsored ELEVATE solid tumor studies and deriving clinical benefit may choose to after re-consenting to the study with their healthcare provider.