Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
Summary
The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).
Timeline
- Start
- 2020-09-09
- Primary completion
- 2023-09-13
- Completion
- 2023-09-13
Outcome
Missed primary endpoint
Stopped: “Study discontinued due to futility based on a planned analysis”
registry analysis (superiority test); Magrolimab + Azacitidine vs Placebo + Azacitidine; p = 0.5218; Odds Ratio (OR) 0.876 (95% CI 0.585 to 1.312) NCT04313881 ↗
registry analysis (superiority test); Magrolimab + Azacitidine vs Placebo + Azacitidine; p = 0.1299; Hazard Ratio (HR) 1.203 (95% CI 0.947 to 1.528) NCT04313881 ↗
paper CONCLUSION: ENHANCE did not meet the primary end points of CR rate and OS PMID 42441929 ↗
release “today announced that the Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis.” gilead.com ↗
Publications
- Sallman DA, Garcia-Manero G, Daver N, Abboud CN, Stein E, Larkin K, Halpern AB, McCurdy SR, Al Malki MM, Subramanian Guru Murthy G, Silverman LR, Larson RA, Greenberg P, Gojo I, Wrobel T, Platzbecker U, Forsyth C, Vachhani P, Dong M, Shao J, Johnson LDS, Tan A, Lee C, Doshi P, Vyas P, Wei AH. Magrolimab Plus Azacitidine Versus Placebo Plus Azacitidine in Patients With Untreated Higher-Risk Myelodysplastic Syndromes: The Phase III ENHANCE Study. J Clin Oncol. 2026 Jul 13:JCO2500617. doi: 10.1200/JCO-25-00617. Online ahead of print.
- Sallman DA, Al Malki MM, Asch AS, Wang ES, Jurcic JG, Bradley TJ, Flinn IW, Pollyea DA, Kambhampati S, Tanaka TN, Zeidner JF, Garcia-Manero G, Jeyakumar D, Komrokji R, Lancet J, Kantarjian HM, Gu L, Zhang Y, Tan A, Chao M, O'Hear C, Ramsingh G, Lal I, Vyas P, Daver NG. Magrolimab in Combination With Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes: Final Results of a Phase Ib Study. J Clin Oncol. 2023 May 20;41(15):2815-2826. doi: 10.1200/JCO.22.01794. Epub 2023 Mar 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Magrolimab | Monoclonal antibody | 30 mg/kg | Intravenous |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |