Gilead Sciences has announced its plans to halt the Phase 3 ENHANCE study of magrolimab plus azacytidine in higher-risk myelodysplastic syndromes (MDS) due to futility based on a planned analysis.

Magrolimab is an investigational monoclonal antibody that binds to CD47 and blocks the inhibitory CD47-signal regulatory protein (SIRPα) interaction. This increases the ability of macrophages and other phagocytes to detect and destroy foreign and malignant cells.

It is being developed for several hematologic cancers and solid tumour malignancies.

The safety data from this trial are in line with the known adverse event profile for magrolimab and the prevalence of these events in this patient population.

In individuals with MDS, Gilead intends to stop the magrolimab therapy.

Magrolimab’s clinical development programme spans ten potential indications including ongoing trials in solid tumours.

The programme also has two trials including an ENHANCE-2 study in acute myeloid leukaemia (AML) with TP53 mutations and ENHANCE-3 in first-line, unfit AML.

Gilead Sciences chief medical officer Merdad Parsey 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.”

The Phase 3 ENHANCE trial is a randomised, double-blind study that was intended to assess the combination of magrolimab plus azacitidine as first-line treatments for higher-risk MDS.

It recruited around 500 patients who were randomised to get magrolimab combination or azacitidine monotherapy.

The primary endpoints were defined as complete response and overall survival whereas the secondary endpoints consisted of duration of response, transfusion independence, progression-free survival, and time to transformation to acute myeloid leukaemia.

Recently, the firm announced that the US Food and Drug Administration (FDA) has cleared the supplemental new drug application (sNDA) for the use of Veklury in Covid-19 patients with severe renal impairment, including those receiving dialysis.