Almost 60% of patients with low-to-medium risk myelodysplastic syndromes were able to stop having blood transfusions after being treated with the new drug luspatercept, a US-based phase III trial has concluded.
The results from the Phase III COMMANDS trial, led by researchers from The University of Texas MD Anderson Cancer Center, were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting last week.
The study evaluated the efficacy and safety of first-line treatment with luspatercept, which enhances red blood cell maturation, compared with epoetin alfa, which is used for low blood cell count. The patients in the trial were transfusion-dependent with anaemia due to very low-to-intermediate-risk MDS.
The trial enrolled 301 patients at 226 sites, and participants were randomised to receive either subcutaneous luspatercept every three weeks or subcutaneous epoetin alfa weekly, for 24 weeks. Patient characteristics were balanced across both treatment arms.
The primary endpoint of the study was independence from red blood cell transfusions at any point after 12 weeks and a mean haemoglobin increase of more than 1.5g/dL within the first 24 weeks.
The interim analysis showed 58.5% of patients receiving luspatercept achieved this primary endpoint, compared to 31.2% of patients who received epoetin alfa.
Looking solely at transfusion independence, within the first 24 weeks of treatment transfusion, 47.6% of luspatercept patients achieved transfusion independence compared with 29.2% of patients who received epoetin alfa.
The study team also found 74.1% of patients who received luspatercept saw haematologic improvement in erythroid responses (HI-E) after 8 weeks, compared to 51.3% of patients who received epoetin alfa.
Lead study investigator Dr Guillermo Garcia-Manero, professor of leukaemia at MD Anderson, said: “Patients with myelodysplastic syndromes often experience anaemia that requires frequent red blood cell transfusions.
“In this study, we observed a significant improvement in patient red blood cell counts with luspatercept, representing a promising advance to enhance the lives of these patients.”
He added he was encouraged by the results and study participants will continue to be followed long term to determine overall survival, time of transfusion independence and frequency of progression to acute myeloid leukaemia.
Garcia-Manero G, Platzbecker U, Santini V, Zeidan AM, Fenaux P, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Kreitz S, Pozharskaya V, Shetty JK, Degulys A, Finelli C, Cluzeau T, Della Porta MG. (2023) “Efficacy and safety results from the COMMANDS trial: A phase 3 study evaluating luspatercept vs epoetin alfa in erythropoiesis-stimulating agent (ESA)‑naive transfusion-dependent (TD) patients (pts) with lower‑risk myelodysplastic syndromes (LR-MDS).”. ASCO Annual Meeting 2023.
Link to abstract: https://meetings.asco.org/abstracts-presentations/219861
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