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July 24, 2023 - Gilead drops CD47 candidate in Phase 3 study

Gilead as discontinued Phase III ENHANCE study of its investigational anti-CD47 antibody magrolimab for the treatment of patients with higher-risk myelodysplastic syndromes, the company announced Friday. 

In January 2022, the FDA slapped a partial clinical hold on all trials evaluating magrolimab in combination with Bristol Myers Squibb’s azacytidine—marketed under the brand names Vidaza and Onureg—preventing the enrollment of new participants into these studies. Patients who had already been enrolled were allowed to continue treatment under tight monitoring by Gilead. 

The initial hold was applied only to trials evaluating the drug combination. The company revealed a week later two more magrolimab studies, which did not pair the antibody with azacytidine. The regulatory pauses were triggered by a higher-than-expected prevalence of serious adverse events. 

The studies affected by the partial hold were in diffuse large B-cell lymphoma, multiple myeloma, AML and MDS.

Beyond MDS, however, Gilead will continue the development of magrolimab in acute myeloid leukemia (AML), for which it is running the ENHANCE-2 study in patients with TP53 mutations and the ENHANCE-3 trial to assess the antibody as a first-line treatment option.

https://www.biospace.com/article/gilead-drops-late-stage-trial-for-magrolimab-in-blood-cancer-treatment/