The US Food and Drug Administration (FDA) has placed a full clinical hold on all the clinical trials of Gilead Sciences' magrolimab for myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML).
This includes related expanded access programmes.
Concurrently, Gilead discontinued the Phase III ENHANCE-3 clinical trial of magrolimab in AML patients.
The ENHANCE-3 trial is designed to assess the efficacy and safety of magrolimab plus venetoclax plus azacitidine as against placebo plus venetoclax and azacitidine in recently diagnosed, untreated AML patients who are not eligible to receive intensive chemotherapy.
The decision to halt the study comes after the trial’s independent Data Monitoring Committee reviewed top-line interim analysis trial findings for overall survival (OS) and recommended the discontinuation.
Analysis indicated that magrolimab plus azacitidine and venetoclax proved to be futile and with increased mortality, primarily due to infections and respiratory failure.
These findings, along with data from two other clinical studies in higher-risk MDS (ENHANCE) and AML with TP53 mutations (ENHANCE-2), which also demonstrated futility and higher death risk in the magrolimab-treatment group, led the company to decide against further development of magrolimab in haematologic cancers.
Patients currently enrolled in the ENHANCE-3 study will stop receiving magrolimab treatment.
Gilead also announced plans to report a top-line, integrated summary of all the magrolimab trials, including ENHANCE, ENHANCE-2, and ENHANCE-3, shortly.
The company is currently reviewing the safety profile of magrolimab across all ongoing solid tumour trials and will update this assessment as soon as it is feasible.
Last September, the company announced the termination of a Phase III trial of magrolimab.
The company terminated the ENHANCE-2 trial in AML with TP53 mutations.
Gilead Sciences chief medical officer Merdad Parsey said: “The complexity of treating blood cancer is highlighted in these results.
“We are incredibly grateful to all the patients and investigators for their participation in the ENHANCE studies.”
