Gilead Sciences Inc GILD said it paused tumor study enrollment.
The Food and Drug Administration (FDA) subsequently requested a partial clinical hold on these trials.
Gilead is reviewing the benefit-risk of magrolimab across all ongoing trials and will provide an update on this assessment as soon as possible.
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 studies in:
- Head and neck squamous cell carcinoma.
- Solid tumors.
- Triple-negative breast cancer.
- Colorectal cancer.
The enrollment hold also applies to investigator-sponsored studies with magrolimab in solid tumors.
Just last week, Gilead discontinued the Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) and that the FDA placed all magrolimab studies in myelodysplastic syndromes (MDS) and AML, including related expanded access programs, on full clinical hold.
Gilead will not pursue further development of magrolimab in hematologic cancers.
In September, Gilead stopped its ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations, evaluating magrolimab plus azacitidine.
In August, the FDA placed a partial clinical hold on initiating new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML). The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS).
Earlier this month, Gilead reported weak earnings results and issued soft guidance.
Price Action: GILD shares are down 2.22% at $71.74 on the last check Friday.
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