Gilead terminates phase 3 trial of magrolimab regimen for myelodysplastic syndrome
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A phase 3 trial of magrolimab plus azacitidine for higher-risk myelodysplastic syndrome has been terminated because of futility, according to a press release.
Gilead Sciences recommended patients with myelodysplastic syndrome stop receiving magrolimab, a potential first-in-class, anti-CD47 immunotherapy, based on the findings of a planned analysis of the ENHANCE study.
“While this is disappointing news, it confirms the challenges of treating [higher-risk myelodysplastic syndrome], where no new class of treatments has been approved in nearly 20 years,” Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, said in the press release. “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 ENHANCE study enrolled more than 500 patients randomly assigned to first-line treatment with magrolimab plus azacitidine or azacitidine monotherapy.
Complete response and OS served as primary endpoints, with duration of response, transfusion independence, PFS and time to transformation to acute myeloid leukemia among the secondary endpoints.
Safety data appeared consistent with the known profile for magrolimab.
Data will be submitted for presentation at a future medical meeting, the press release stated.
The clinical development program for magrolimab spans 10 potential indications, with ongoing studies in solid tumors and pivotal trials that include ENHANCE-2 in AML with TP53 mutations and ENHANCE-3 in first-line, unfit AML, according to Gilead.
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