Gilead Terminates Phase III ENHANCE Study of Magrolimab in High-Risk Myelodysplastic Syndromes Due to Futility

On July 21, Gilead Sciences announced that the Phase III ENHANCE study of magrolimab, a CD47 antibody, in combination with azacitidine for the treatment of high-risk myelodysplastic syndrome (MDS), was terminated due to ineffective results in the planned analysis. The safety data in this study were consistent with the known profile of magrolimab and typical adverse events observed in this patient population. Gilead recommends that MDS patients discontinue magrolimab treatment.

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.

Magrolimab’s clinical development program covers 10 potential indications, including two ongoing pivotal trials: the ENHANCE-2 study for TP53-mutated acute myeloid leukemia (AML), and the ENHANCE-3 study for frontline treatment of AML patients unfit for intensive chemotherapy.

ENHANCE is a randomized, double-blind study evaluating magrolimab in combination with azacitidine as a first-line therapy for high-risk myelodysplastic syndrome (HR-MDS). The study enrolled 520 patients who were randomly assigned to receive either magrolimab plus azacitidine or azacitidine monotherapy. The primary endpoints are complete response and overall survival.

The road to Gilead's development of magrolimab has not been smooth. In January 2022, the FDA partially placed a hold on Gilead’s combination study of magrolimab + azacitidine after researchers reported a significant imbalance in suspected unexpected serious adverse reactions (SUSARs) across study groups. In April of the same year, Gilead received clearance from the FDA. After reviewing comprehensive safety data from each trial, the FDA lifted the partial clinical hold on the combination study of magrolimab + azacitidine.

"The health and well-being of patients are our top priorities. While this is disappointing news, it underscores the challenges in treating HR-MDS, for which no new therapies have been approved in nearly 20 years," said Merdad Parsey, MD, Chief Medical Officer of Gilead Sciences. "Gilead is deeply grateful to the patients, families, researchers, and advocacy groups who contributed to this study. We will further explore magrolimab's potential, including its use in treating other cancers."

Gilead is working with investigators to determine appropriate next steps for patients enrolled in the ENHANCE study and plans to submit the data for presentation at an upcoming medical conference.

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