Magrolimab Plus Azacitidine Versus Placebo Plus Azacitidine in Patients With Untreated Higher-Risk Myelodysplastic Syndromes: The Phase III ENHANCE Study.
A large trial showed adding an immune-boosting antibody to standard MDS treatment didn't improve survival and caused more severe side effects, preventing adoption of a harmful regimen.
The ENHANCE phase 3 RCT (n=539) definitively showed that adding the anti-CD47 antibody magrolimab to azacitidine did not improve complete remission or overall survival in treatment-naive higher-risk MDS patients, and caused significantly more severe and fatal adverse events than azacitidine alone. This negative result closes a major clinical question about CD47 blockade combined with hypomethylating agents in front-line higher-risk MDS and prevents adoption of a more toxic but ineffective regimen.
What the study was
- Study design
- Phase 3 randomized double-blind placebo-controlled trial
- Population
- Treatment-naive intermediate- to very-high-risk MDS patients (IPSS-R; n=539)
- Sample size
- 539
- Category
- Treatment Innovation
- Maturity
- Validated
- Journal
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Why it surfaced
High-powered phase 3 RCT in a high-unmet-need population; definitively negative result with increased toxicity is immediately practice-relevant, preventing adoption of magrolimab plus azacitidine in front-line higher-risk MDS.
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