Gilead Sciences discontinues Phase 3 ENHANCE Study on higher-risk MDS due to futility

Biopharmaceutical firm Gilead Sciences (Nasdaq: GILD) has announced the termination of its Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) due to a lack of promising results, according to a planned analysis.

The safety data observed during the trial was found to align with the known profile of magrolimab, an investigational anti-CD47 immunotherapy drug candidate, and typical adverse events among this patient population. The company has advised discontinuation of treatment with magrolimab for patients with myelodysplastic syndromes.

Merdad Parsey, Chief Medical Officer at Gilead Sciences, stated, “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 study evaluated the combination of magrolimab and azacitidine as first-line treatments for higher-risk MDS. The randomized, double-blind study enrolled over 500 patients, who received either the combined therapy or azacitidine monotherapy. The primary endpoints included overall survival and complete response, while secondary endpoints encompassed duration of response, progression-free survival, transfusion independence, and time to transformation to acute myeloid leukemia (AML), among others.

Gilead Sciences will now work closely with study investigators to determine the next steps for patients enrolled in the ENHANCE study. The firm also intends to submit the data from the study for presentation at an upcoming medical conference.