On July 21, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis (Press release, Gilead Sciences, JUL 21, 2023, View Source [SID1234633365]). The safety data seen in this study is consistent with the known magrolimab profile and adverse events that are typical in this patient population. Gilead recommends discontinuing treatment with magrolimab in patients with MDS. Magrolimab is a potential first-in-class, anti-CD47 immunotherapy with a clinical development program spanning ten potential indications including ongoing trials in solid tumors and two pivotal trials: ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations and ENHANCE-3 in first-line, unfit AML.
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"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," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "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."
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.
About ENHANCE
The Phase 3 randomized, double-blind study evaluated the combination of magrolimab plus azacitidine as first-line treatments for higher-risk myelodysplastic syndromes (HR-MDS), a disease without a new class of treatments approved in almost 20 years. The study enrolled more than 500 patients who were randomized to receive magrolimab in combination with azacitidine or azacitidine monotherapy. Primary endpoints were complete response and overall survival. Secondary endpoints included duration of response, transfusion independence, progression free survival, and time to transformation to acute myeloid leukemia, among others. Additional information can be found at www.clinicaltrials.gov (NCT04313881).
About Magrolimab
Magrolimab is a potential, first-in-class investigational monoclonal antibody that binds to CD47. The primary mechanism of action of magrolimab is to block the inhibitory CD47-signal regulatory protein (SIRPα) interaction, enhancing the ability of macrophages and other phagocytes to identify and destroy foreign and malignant cells, with the goal of blocking the "don’t eat me" signal used by cancer cells. Magrolimab is a novel immunotherapy being developed in several hematologic cancers and solid tumor malignancies. More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.