EHA24: New data detail demise of Gilead's magrolimab in high-risk MDS

16 Jun 2024
firstwordpharma.com
Phase 3ImmunotherapyClinical ResultPhase 2Clinical Trial Failure
According to Phase III study details presented at the European Hematology Association (EHA) meeting, Gilead Sciences' $4.9-billion CD47 bet magrolimab was both ineffective and associated with a higher risk of death among patients with untreated higher-risk myelodysplastic syndrome (MDS).
The company axed the drug's development in haematologic cancers earlier this year after three clinical trials in MDS and acute myeloid leukaemia (AML) had revealed a mortality signal. That was followed soon after by Gilead pausing work on the anti-CD47 antibody in solid tumours as well. The investigational anti-CD47 immunotherapy, which Gilead acquired through its 2020 takeout of Forty Seven in 2020, was officially scrapped all together at the end of April.
Results from the 539-patient ENHANCE study presented at EHA showed that when combined with standard-of-care azacitidine, magrolimab failed on the study's primary endpoints of overall survival (OS) and complete remission (CR) rate compared to placebo plus azacitidine in previously untreated patients with higher-risk MDS.
At the final analysis, best response of CR was lower at 21.3% for patients receiving magrolimab, compared to 23.6% for the placebo group. Median CR duration was also lower at 10.9 months and 11.1 months, respectively. The magrolimab regimen was associated with a 20% increased risk of death, although the difference between the arms was not statistically significant. Median OS was 15.9 months with the magrolimab plus azacitidine versus 18.6 months for controls.
"Confounding factors, such as imbalance in patients eligible for transplant and a partial clinical hold during enrollment, may limit data interpretation," researchers said in the ENHANCE study's abstract.
Safety was also a concern. The magrolimab combination arm saw a higher rate of Grade ≥3 and treatment-related side effects compared to azacitidine alone, including neutropenia (44.5% vs 40.9%), anaemia (42.6% vs 21.2%), thrombocytopenia (40.3% vs 33.3%), and febrile neutropenia (22.8% vs 18.9%). In 2022, an urgent safety measure was introduced to maintain a haemoglobin level of at least 9 g/dL within 24 hours before the first two doses of magrolimab or placebo. While the measure improved tolerability of Gilead's drug, the study was ultimately stopped early due to futility at the interim analysis.
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