FDA Lifts Partial Clinical Hold on Gilead's CD47 Monoclonal Antibody Magrolimab in Combination with Azacitidine for MDS and AML

Compiled by newborn

Recently, Gilead announced that the U.S. FDA has lifted the partial clinical hold on its investigational CD47 monoclonal antibody magrolimab in combination with azacitidine. After reviewing the integrated safety data from each clinical study, the FDA removed some of the partial clinical holds.

Magrolimab is a monoclonal antibody that blocks CD47 signaling, which Gilead acquired for approximately $4.9 billion in April 2020 through the acquisition of Forty Seven. Magrolimab is designed to interfere with the recognition of CD47 by the SIRPα receptor on macrophages, thereby blocking cancer cells from using the "don't eat me" signal to avoid being engulfed by macrophages.

Currently, magrolimab is under development for various hematologic and solid tumor malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), among others. In September 2020, the FDA granted magrolimab Breakthrough Therapy Designation (BTD) for the treatment of newly diagnosed MDS.

In January this year, the FDA partially suspended several clinical trials of magrolimab in combination with azacitidine due to a significant imbalance in suspected unexpected serious adverse reactions (SUSAR) reported by investigators between the treatment groups.

According to the latest decision released by the FDA, the evaluation of clinical studies related to magrolimab in combination with azacitidine for the treatment of MDS and AML will now resume patient enrollment in the United States. Gilead Sciences is working closely with regulatory authorities to plan the reopening of patient enrollment for magrolimab clinical studies voluntarily paused outside the U.S.

Gilead is also collaborating with the FDA on the remaining magrolimab clinical studies for the treatment of diffuse large B-cell lymphoma (DLBCL) and multiple myeloma (MM) that are affected by the partial clinical hold. Ongoing clinical studies evaluating magrolimab for the treatment of solid tumors are not subject to the clinical hold.

During the partial clinical hold, patients already enrolled in the affected magrolimab clinical studies, including those in the pivotal Phase 3 ENHANCE study, continue to receive treatment. Prior to the clinical hold, the ENHANCE study had reached the pre-specified enrollment threshold required for the first interim analysis. Based on this, Gilead believes that the first interim analysis will proceed as planned in 2023. The company remains confident in magrolimab’s risk-benefit profile and believes it has the potential to address unmet medical needs in areas such as MDS and AML.

Reference Source: FDA Lifts Partial Clinical Hold on MDS and AML Magrolimab Studies