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Ropeginterferon alfa-2b in patients with early/lower-risk primary MF
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Pegylated interferon alfa is recommended for the treatment of patients with lower-risk PMF who are symptomatic, based on phase II non-randomized studies and expert opinion. Ropeg shows promise in achieving durable hematologic responses, including normalization of blood counts and control of PMF-related symptoms, and has the potential to modify disease progression. In a recent publication in Annals of Hematology, Abu‑Zeinah et al. outline a planned randomized phase III trial designed to assess the efficacy and safety of ropeg in patients with early/lower-risk PMF.1
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| Key learnings |
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This new phase III trial (NCT06468033) will evaluate the efficacy and safety of ropeg in 150 patients with early/lower-risk PMF, randomized 2:1 to receive either ropeg or placebo. |
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Co-primary endpoints include clinically relevant complete hematologic response and symptom endpoint (no progression of clinical symptoms) at 56 weeks. |
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Secondary endpoints include PFS/EFS, molecular response in driver or relevant coexisting gene mutations, bone marrow response, and safety. |
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The study will provide important data for the treatment of early/lower-risk PMF for which an anti-clonal, disease-modifying agent is highly needed. |
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Ropeg could address a critical unmet need in this patient population by offering a safe and effective option that reduces thrombosis risk and delays disease progression. |
Abbreviations: EFS, event-free survival; MF, myelofibrosis; MPN, myeloproliferative neoplasm; PFS, progression-free survival; PMF, primary myelofibrosis; ropeg, ropeginterferon alfa-2b.
- Abu-Zeinah G, Qin A, Gill H, Komatsu N, et al. A randomized, double-blind, placebo-controlled phase 3 study to assess efficacy and safety of ropeginterferon alfa-2b in patients with early/lower-risk primary myelofibrosis. Ann Hematol. 2024;103(9):3573-3583. DOI: 10.1007/s00277-024-05912-8.
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