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P1101MF phase II results: Ropeginterferon alfa-2b in patients with early or lower-risk MF
Patients with pre-fibrotic primary myelofibrosis (pre-PMF) or low/intermediate-1 risk myelofibrosis (MF) are at risk of thrombotic complications, disease progression, and early mortality. Ropeginterferon alfa-2b, a monopegylated interferon alfa with an extended half-life, is the first interferon specifically developed for myeloproliferative neoplasms and is approved for use in polycythemia vera. The prospective, open-label phase II P1101MF study (NCT04988815) evaluates ropeginterferon alfa-2b in interferon-naïve patients with early/pre-PMF, overt PMF, or post-polycythemia vera/essential thrombocythemia MF in the DIPSS low/intermediate-1 risk categories requiring cytoreduction (n = 71). Ropeginterferon alfa-2b was administered subcutaneously every 2 weeks, starting at 250 mcg (Week 0), escalating to 350 mcg (Week 2), and to 500 mcg (Week 4). At the 2025 European Hematology Association (EHA) Congress, Harry Gill presented findings from P1101MF, with primary endpoints assessing hematologic response and safety, and secondary endpoints evaluating symptom burden, disease progression, thrombotic events, and molecular markers.1
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Key learnings |
At Week 48 (n = 63), hematologic response was achieved in 63.5% of patients, increasing to 70.0% at Week 104. Sustained improvements were seen at Week 104 in Hb (≥10 g/dL in 82.0%), WBC (<10 × 10⁹/L in 82.0%), and platelets (<400 × 10⁹/L in 100%). |
Grade 3–4 hematologic AEs included anemia (8.5%), neutropenia (5.6%), and thrombocytopenia (4.2%). Most nonhematologic AEs were Grade 1–2, with transaminitis (49.2%) and malaise (40.8%) being the most frequent. Discontinuation due to AEs occurred in 4.2% of patients. |
Symptom improvement (≥50% reduction in TSS from baseline) occurred in 42.1% of patients (n = 23/57) at Week 48. Median symptom scores improved vs baseline for fatigue (–25.0%), night sweats (–62.5%), bone pain (–39.3%), and QoL (–25.0%). |
Reductions in JAK2V617F, CALR, ASXL1, EZH2, and TET2 mutation burden were observed. These molecular responses, together with sustained clinical benefit and good tolerability, support the potential of ropeginterferon alfa-2b as a disease-modifying option in early/lower-risk MF. |
Abbreviations: AE, adverse event; ASXL1, additional sex combs like 1; CALR, calreticulin; DIPSS, Dynamic International Prognostic Scoring System; EZH2, enhancer of zeste homolog 2; Hb, hemoglobin; JAK2V617F, Janus kinase 2 V617F mutation; MF, myelofibrosis; PMF, primary myelofibrosis; pre-PMF, pre-fibrotic primary myelofibrosis; QoL, quality of life; TET2, tet methylcytosine dioxygenase 2; TSS, total symptom score; WBC, white blood cell count.
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The phase III SURPASS-ET trial demonstrated the efficacy of ropeginterferon alfa-2b (ropeg) as a second-line treatment for essential thrombocythemia (ET). Of your patients with ET, what proportion are you currently treating with ropeg?
