ENHANCE: Magrolimab does not ameliorate health outcomes in high-risk MDS

A benefit of magrolimab plus azacitidine over azacitidine alone could not be found for participants with high-risk myelodysplastic syndrome (MDS), the final analysis of the phase 3 ENHANCE trial showed. According to the authors, this finding highlights the challenge of developing efficacious therapies for this heterogeneous disease.

The phase 3 ENHANCE trial (NCT04313881) compared a regimen of the standard of care azacitidine in combination with CD47 inhibitor magrolimab versus azacitidine plus a placebo among 539 participants with high-risk MDS [1].

“The final analysis of ‘best response of clinical remission (CR)’ did not show a difference between the experimental arm [21.3%] and the control arm [23.6%],” concluded Dr David Sallman (Moffitt Cancer Center, FL, USA). In TP53-mutated participants, the CR rate was lower for participants treated with magrolimab than their placebo control (17.7% vs 32.8%). Fewer participants in the experimental arm proceeded to stem cell transplantation (20.9% vs 35.4%). The overall survival (OS) data at this final analysis did not display a difference between the experimental arm and control arm either (median OS 15.9 months vs 18.6 months). “This finding was consistent across subgroups,” added Dr Sallman.

“Unfortunately, we noticed a higher percentage of treatment-emergent adverse events leading to discontinuation in the magrolimab arm,” expressed Dr Sallman (24.0% vs 12.1%). “Anaemia and, to a lesser extent, thrombocytopenia were more common adverse events in the experimental than in the control arm.”

The ENHANCE study did not meet the primary efficacy endpoints, and more safety issues were observed when adding magrolimab to azacitidine. “High-risk MDS is a heterogeneous disease with a high unmet need,” said Dr Sallman. “Developing successful anti-CD47 therapies for this disease remains a challenge.”

1. Sallman D, et al. Magrolimab plus azacitidine vs placebo plus azacitidine in patients with untreated higher-risk myelodysplastic syndromes: phase 3 ENHANCE study final analysis. S181, EHA congress 2024, 13–16 June, Madrid, Spain.

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Posted on 12 August 2024