FDA places full clinical hold on Gilead’s investigational blood cancer treatment
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The FDA placed a clinical hold on studies evaluating magrolimab for the treatment of acute myeloid leukemia and myelodysplastic syndromes, according to a statement released by the manufacturer.
The agency issued the hold after an independent saftey monitoring committee determined that magrolimab (Gilead Sciences) in combination with azacitidine plus venetoclax failed to improve OS during an analysis of topline data from the ENHANCE-3 study. Results also showed an increased the risk for death using the investigational regimen, with infections and respiratory failure driving the additional morality.
The regulatory action has resulted in the agent’s manufacturer announcing its intent to discontinue the phase 3 study and all further development of anti-CD47 monoclonal antibody.
As Healio previously reported, Gilead terminated two other clinical trials evaluating magrolimab for treatment of higher-risk MDS and TP53-mutant AML. The manufacturer closed both studies after an interim analysis failed to show any OS benefit and increased risk for death among those who received the investigational agent.
“The complexity of treating blood cancer is highlighted in these results,” Merdad Parsey, MD, PhD, chief medical officer with Gilead, said in the release. “We are incredibly grateful to all the patients and investigators for their participation in the ENHANCE studies.”
Participants in the ENAHCE-3 trial will immediately discontinue treatment with magrolimab, according to the statement. The manufacture also said it plans to provide more detailed results from the closed trials at upcoming medical conferences, in addition to evaluating the saftey of magrolimab in ongoing solid tumor trials.
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