February 8, 2024: Gilead Sciences, Inc., announced it has discontinued trials on a drug to treat blood cancer after the US regulatory body placed the experiments on full clinical hold, according to a company statement.
The US Food and Drug Administration has frozen all magrolimab studies following the recommendations of an independent Data Monitoring Committee.
The committee reviewed data from the interim analysis for the overall survival of patients suffering from acute myeloid leukaemia.
“In that analysis, magrolimab in combination with azacitidine plus venetoclax demonstrated futility and an increased risk of death was observed, primarily driven by infections and respiratory failure,” according to the statement.
The final trials evaluated the safety and efficacy of magrolimab versus placebo in combination with venetoclax plus azacitidine in newly diagnosed, previously untreated patients with leukaemia and who were ineligible for intensive chemotherapy.
The results and two other clinical studies have demonstrated “futility with an increased risk of death in the magrolimab-treatment arm. Gilead will not pursue further development of magrolimab in hematologic cancers.”
“The complexity of treating blood cancer is highlighted in these results,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
Gilead will share an integrated summary of all pivotal magrolimab trials shortly, as well as more detailed results of each trial in upcoming medical conferences or a publication.
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“Gilead is reviewing the safety of magrolimab across all ongoing solid tumour trials and will provide an update on this assessment as soon as possible.”
The biopharmaceutical company operates in more than 35 countries worldwide, with headquarters in Foster City, California, US.
About every three minutes, one person in the US is diagnosed with leukaemia, lymphoma or myeloma. An estimated combined total of 184,720 people in the US are expected to be diagnosed with leukaemia, lymphoma or myeloma in 2023.
New cases of leukaemia, lymphoma and myeloma are expected to account for 9.4% of the estimated 1,958,310 new cancer cases that will be diagnosed in the US in 2023.