Gilead Sciences has announced in a press release that they are going to discontinue the phase 3 ENHANCE study of the use of magrolimab and azacitidine in treating higher-risk myelodysplastic syndromes (MDS).
This decision was taken based on an analysis that found any attempts to proceed ahead with the study to be “futile,” according to the press release. The safety data and the adverse events recorded are consistent with what is already known about magrolimab. Gilead Sciences now recommends that the therapeutic be discontinued among patients with higher-risk MDS.
“The health and well-being of patients are our top priorities and while this is disappointing news, it confirms the challenges of treating higher-risk myelodysplastic syndromes, where no new class of treatments have been approved in nearly 20 years,” said Merdad Parsey, MD, PhD, chief medical officer of the company.
Magrolimab has been under heavy investigation in recent years due its potential use in a wide range of diseases, including solid tumors and acute myeloid leukemia. It is a monoclonal antibody that binds to CD47, which should theoretically increase the ability of macrophages and phagocytes to identify and destroy foreign and/or malignant cells.
Read more about MDS etiology
The phase 3 ENHANCE study sought to assess the merits of magrolimab plus azacitidine as first-line therapies for higher-risk MDS, a disorder in which therapeutic innovation has remained stagnant for nearly 2 decades. Before the decision to discontinue was made, the trial had a promising design, recruiting 500 patients randomized to receive the combination therapy or azacitidine monotherapy.
“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,” Parsey added.
Gilead Sciences remains committed to pursuing innovative approaches to preventing and treating life-threatening diseases such as HIV, viral hepatitis, COVID-19, and cancer, among others.
Gilead to discontinue phase 3 ENHANCE study of magrolimab plus azacitidine in higher-risk MDS. News release. Gilead Sciences, Inc.; July 21, 2023.