Luspatercept Shows Superior Efficacy Compared to Epoetin Alfa in Myelodysplastic Syndromes Patients, Study Finds
Introduction
Myelodysplastic syndromes (MDS) are a group of diseases in which the bone marrow fails to produce enough healthy blood cells, including red blood cells. Patients with MDS often experience symptoms such as anemia, fatigue, shortness of breath, and increased vulnerability to infection. Due to the frequency of anemia, most patients require regular red blood cell transfusions. Some cases of MDS can progress to acute myeloid leukemia (AML). However, a new study has found that treatment with luspatercept improved red blood cell counts and erythroid responses compared to treatment with epoetin alfa in patients with MDS, allowing the majority to no longer require regular blood transfusions.
The COMMANDS Trial
The Phase III COMMANDS trial evaluated the efficacy and safety of first-line treatment with luspatercept, which enhances red blood cell maturation, compared with epoetin alfa, a therapy commonly used for low blood cell count, in transfusion-dependent patients with anemia due to very low- to intermediate-risk MDS. The study enrolled 301 patients at 226 sites. Patients were randomized to receive subcutaneous luspatercept every three weeks or subcutaneous epoetin alfa weekly for 24 weeks. Patient characteristics were balanced across both treatment arms.
Results
In this interim analysis, 58.5% of patients receiving luspatercept achieved the primary endpoint of independence from red blood cell transfusions compared to 31.2% of patients who received epoetin alfa. Within the first 24 weeks of treatment transfusion, 47.6% of luspatercept patients achieved transfusion independence versus 29.2% of patients receiving epoetin alfa. Additionally, 74.1% of patients who received luspatercept saw hematologic improvement in erythroid responses greater than eight weeks, compared to 51.3% of patients who received epoetin alfa.
Safety Profile
Treatment-related adverse events of all grades occurred in 30.3% of patients in the luspatercept group and 17.6% in the epoetin alfa group. Eight patients (4.5%) that received luspatercept discontinued treatment due to treatment-related adverse events. AML progression was reported in four patients receiving luspatercept and five patients receiving epoetin alfa. The safety profile was consistent with previous studies of the drug.
Conclusion
Guillermo Garcia-Manero, M.D., professor of Leukemia and lead investigator of the study, said “These results show, for the first time, superior effectiveness of an innovative therapy over epoetin alfa. I am encouraged by these results, as luspatercept represents a transformative therapy that could become a new standard of care for patients with transfusion-dependent myelodysplastic syndromes.” The patients in this study continue to be followed long term to determine overall survival, time of transfusion independence and frequency of progression to AML. The study was funded by Bristol Myers Squibb. Garcia-Manero has worked in a consulting/advisory role for and received research support from Bristol Myers Squibb.
- Myelodysplastic syndromes treatment
- Luspatercept therapy
- Red blood cell count improvement
- Hemoglobin level boost
- Anemia management in MDS patients
News Source : News-Medical.net
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