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Luspatercept for the treatment of myelofibrosis with anemia: Latest data from ACE-536-MF-001
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Results of the phase II, open-label ACE-536-MF-001 trial (NCT03194542) were published in Blood Advances by Gerds et al.1 This study evaluated the efficacy and safety of luspatercept in patients with MF and anemia, including those with and without red blood cell transfusion dependence and concurrent JAKi therapy.1 |
| Key learnings |
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Among non-transfusion dependent patients, 18.2% of patients without concurrent Rux and 21.4% with Rux experienced an anemia response, defined as a ≥1.5 g/dL Hb increase for 84 consecutive days without transfusion. |
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Of all cohorts, the highest anemia response rates were observed in patients receiving concurrent Rux therapy, supporting the use of luspatercept in combination with JAKi to manage anemia in MF. |
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Among patients who were transfusion-dependent, a reduction in dependance was observed in 47.6% without concurrent Rux and 52.6% with Rux. |
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A reduction in TSS was observed across all cohorts, with the highest response in the cohort of patients who were not transfusion dependent and were treated with Rux. |
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TRAE were observed in 47.4% of patients, with the most common being hypertension in 17.9%. There was one incidence of treatment discontinuation due to serious TRAE. |
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There is an unmet need to reduce transfusion dependence in MF to enhance patient quality of life and healthcare resource utilization. |
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These data support luspatercept as a feasible option for the treatment of anemia in patients with MF, reducing the need for transfusions and potentially allowing maintenance of JAKi therapy. A phase III trial of luspatercept in transfusion-dependent patients with MF receiving concomitant JAKi therapy is underway (INDEPENDENCE, ACE-536-MF-002). |
Abbreviations: Hb, hemoglobin; JAKi, Janus kinase inhibitor; MF, myelofibrosis; Rux, ruxolitinib; TRAE, treatment-related adverse events; TSS, total symptom score.
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