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Impact of luspatercept on Hb and QoL in non-transfusion-dependent MF: A post hoc analysis of ACE-536-MF-001
Anemia, a common complication in myelofibrosis (MF), is associated with fatigue and reduced quality of life (QoL). The phase II ACE-536-MF-001 (MF-001) trial (NCT03194542) demonstrated that luspatercept improved hemoglobin (Hb) levels in patients with MF. However, the relationship between Hb levels and anemia-related QoL remains unclear. During the European Hematology Association (EHA) 2025 Congress, June 12–15, 2025, Milan, IT, Haifa Al-Ali presented data from a post hoc analysis of the MF-001 trial assessing the relationship between Hb levels and QoL in non-transfusion-dependent (NTD) patients with MF treated with luspatercept.1 Data from two cohorts were analyzed (N = 36). Eligible patients had Hb levels ≤9.5 g/dL recorded on ≥3 separate days and received no transfusions in the 84 days prior to their first dose of luspatercept. Both cohorts received 1.0 mg/kg luspatercept on Day 1 of each 3-week cycle. QoL was evaluated using the Functional Assessment of Cancer Therapy – Anemia tool, with fatigue and anemia subscales.
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Key learnings |
Meaningful improvements in FS (coefficient 4.32; p < 0.001) and AnS (coefficient 5.26; p = 0.001) were more likely with an increase in Hb levels from baseline of ≥1.5 g/dL compared with an increase of <1.5 g/dL. |
A change from baseline in Hb of ≥1.5 g/dL (p < 0.01) or reaching a target Hb level of ≥10 g/dL (p < 0.05) were predictors of improvement in FS and AnS scores. |
Among evaluable patients with a mean Hb increase ≥1.5 g/dL, 66.7% and 83.3% achieved at least one meaningful improvement in FACT-FS and FACT-AnS during a clinical response, respectively. |
These findings demonstrate a clinically meaningful relationship between increased Hb levels and anemia-related QoL, highlighting the QoL benefits of luspatercept in NTD patients with MF. |
AnS, Anemia subscale, EHA, European Hematology Association; FACT, Functional Assessment of Cancer Therapy; FS, fatigue subscale; Hb, hemoglobin; MF, myelofibrosis; NTD, non-transfusion-dependent; QoL, quality of life.
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