Gilead halts enrollment in solid tumor trials

Feb. 16, 2024

Gilead Sciences has halted enrollment globally in its magrolimab solid tumor studies.

The decision follows a request from the FDA for a partial clinical hold on the trials. The FDA's request comes on the heels of a previous full clinical hold on all magrolimab studies in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), following reports of increased death risk.

Magrolimab, a monoclonal antibody, is undergoing clinical development for the treatment of various cancers, including myelodysplastic syndrome, acute myeloid leukemia, and diffuse large B-cell lymphoma, where there is a pressing need for innovative treatments. Magrolimab holds the potential to become a first-in-class therapy.

The impacted studies include phase 2 trials in head and neck squamous cell carcinoma, solid tumors, triple-negative breast cancer, and colorectal cancer. Patients already enrolled in Gilead's ELEVATE solid tumor studies and experiencing clinical benefits may opt to continue receiving magrolimab after reconsenting with their healthcare provider.

In its statement, Gilead warned of uncertainties surrounding the progression and completion of clinical trials, potential regulatory hurdles, and the possibility of discontinuing magrolimab development.

Gilead got its hands on magrolimab via its 2020 acquisition of cancer drug developer Forty Seven for $4.9 billion in cash. Forty Seven, headquartered in California, was a clinical-stage immuno-oncology company with a focus on developing novel checkpoint therapies to activate macrophages and combat cancer.