Gilead Halts Second Phase III Trial of CD47 Antibody Magrolimab in TP53-Mutant AML-VCBeat

On September 26, Gilead Sciences announced the discontinuation of the ENHANCE-2 study of CD47 antibody magrolimab for TP53-mutated acute myeloid leukemia (AML). Following a special analysis and review by an independent data monitoring committee, Gilead determined that magrolimab is unlikely to demonstrate a survival benefit in TP53-mutated AML patients compared to standard treatment. No new safety signals were identified in the study, and the safety profiles across treatment groups were comparable.

Magrolimab is a potential first-in-class anti-CD47 immunotherapy acquired by Gilead Sciences through its $4.9 billion acquisition of Forty Seven, Inc. Its primary mechanism of action is blocking the inhibitory interaction between CD47 and signal regulatory protein alpha (SIRPα), enhancing the ability of macrophages and other phagocytic cells to recognize and eliminate foreign and malignant cells, thereby interrupting the "don't eat me" signal emitted by cancer cells.

ENHANCE-2 is a randomized, open-label Phase III trial designed to evaluate whether magrolimab combined with azacitidine can improve overall survival in TP53-mutated AML patients compared to physician's choice of venetoclax combined with azacitidine or intensive chemotherapy, in patients who are previously untreated.

Gilead is working with investigators to determine the appropriate next steps for patients enrolled in this study. This decision follows the previously announced partial clinical hold on the ENHANCE-2 study.

In August this year, Gilead Sciences announced that the FDA had partially placed a hold on the enrollment of new patients in the magrolimab treatment study for acute myeloid leukemia (AML) being conducted in the United States. Gilead is working with regulatory authorities to determine the next steps to lift the partial clinical hold.

In July, the Phase III ENHANCE study of magrolimab combined with azacitidine for the treatment of high-risk myelodysplastic syndrome (MDS) was terminated due to ineffective planned analysis results.

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