Gilead Sciences has discontinued the Phase III ENHANCE study of magrolimab, along with azacitidine, for the treatment of higher-risk myelodysplastic syndromes (MDS).
The double-blind, randomised study has been discontinued due to futility observed during a planned analysis.
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Patients treated with the combined therapy showed typical adverse events and the safety data was consistent with the known magrolimab profile.
More than 500 patients were enrolled in the study and randomised to receive the combined therapy or azacitidine alone.
Overall survival and complete response were the primary endpoints while progression free survival and transfusion independence were included as the secondary endpoints.
The study also measured the duration of response and the time to transformation to acute myeloid leukaemia (AML) as secondary endpoints.
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.”
Working with the investigators, the company is taking suitable measures for the enrolled patients in the study.
Magrolimab is a monoclonal antibody that blocks the interaction of the CD47-signal regulatory protein (SIRPα) to destroy cancerous cells.
It is also being investigated in the ENHANCE-2 study to treat AML harboring TP53 mutations, in ENHANCE-3 as first-line treatment for unfit AML, and in other ongoing trials to treat solid tumours.
