The company said the safety data seen in this study is consistent with the known magrolimab profile and adverse events that are typical in this patient population. However, it recommends discontinuing treatment with magrolimab in patients with MDS.
Magrolimab is a monoclonal antibody with potentially first-in-class potential. It binds to CD47, a surface protein commonly overexpressed in cancer cells, which use it to hide from the body’s immune system. By blocking CD47, magrolimab restores this anti-cancer activity to enable macrophages and other phagocytic cells to target and eliminate cancer cells.
The discontinued study enrolled more than 500 patients who were randomized to receive magrolimab in combination with azacitidine or azacitidine monotherapy.
Moving forward, Gilead is working with study investigators on appropriate next steps for patients enrolled in the ENHANCE study. Data will be submitted for presentation at an upcoming medical meeting.
Beyond MDS, 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.
Merdad Parsey, chief medical officer at Gilead Sciences, said: “The health and well-being of patients are our top priorities and while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years.”
“Gilead is deeply grateful to the patients, families, investigators, and the advocacy community who contributed to this research as we learn more about magrolimab and explore its potential in treating other cancers.”