Magrolimab Plus Azacitidine Versus Placebo Plus Azacitidine in Patients With Untreated Higher-Risk Myelodysplastic Syndromes: The Phase III ENHANCE Study.
David A Sallman, Guillermo Garcia-Manero, Naval Daver et al.
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In 30 seconds
The phase III ENHANCE study evaluated the efficacy and safety of magrolimab plus azacitidine versus placebo plus azacitidine in treatment-naïve patients with higher-risk myelodysplastic syndromes. The study found that the complete remission rate was 21.3% for Magro/Aza compared to 23.6% for Placebo/Aza, with a median overall survival of 15.9 months versus 18.6 months, respectively.
Key findings
- Complete remission rate was 21.3% for Magro/Aza versus 23.6% for Placebo/Aza (P = .5218).
- Median overall survival was 15.9 months for Magro/Aza compared to 18.6 months for Placebo/Aza (P = .1299).
- Magro/Aza had a higher incidence of grade ≥3 adverse events at 92.8% compared to 79.2% for Placebo/Aza.
- Fatal adverse events occurred in 15.2% of Magro/Aza patients versus 9.8% in Placebo/Aza.
Why it matters
The findings indicate that magrolimab plus azacitidine does not improve complete remission rates or overall survival compared to azacitidine alone, while also increasing the risk of severe adverse events. This highlights the need for careful consideration of treatment options in higher-risk myelodysplastic syndromes.