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PARADIGM-PV: Ropeginterferon alfa-2b in patients with low- or high-risk polycythemia vera
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Phlebotomy and aspirin are often used to treat patients with low-risk PV; however, data from the phase II Low-PV study (NCT03003325) demonstrated that this intervention may be inadequate. Disease-modifying treatments appear to be beneficial for patients with PV, regardless of risk category. Ropeginterferon alfa-2b (ropeg) is a novel INF-based therapy with favorable dosing schedules, and a higher ropeg starting-dose (250 µg) with simpler dose titrations has demonstrated potent disease-modifying effect in terms of molecular response induction. Flexible dose adjustments and schedule changes with longer intervals (e.g. once every 3–4 weeks after stabilization of treatment response) offer improved convenience for patients, with improved disease outcomes. PARADIGM-PV (NCT06290765) is a randomized, multicenter phase IV study designed to assess the efficacy and safety of ropeg in patients with low- or high-risk PV. Yacoub et al. detail the study rationale, design, and outcome measures in a recent publication in Annals of Hematology. |
| Key learnings |
| Approximately 70 patients with PV will be enrolled. The study period will be 112 weeks, with a 32-week main treatment phase and an 80-week extension treatment phase, plus an additional 4-week safety follow-up phase. |
| The primary goal is to assess the efficacy of ropeg with a higher starting dose (250 µg) and flexible dosing schedules in reducing phlebotomy dependence, while maintaining Hct values in patients with both low- and high-risk PV. |
| The primary endpoint will be the proportion of patients achieving a response at Week 20–32. Secondary endpoints will include CHR, molecular response, symptom improvement, maintenance of median Hct <45% without PD, and safety. |
| The higher starting dose with subsequently reduced-intensity/stringency maintenance therapy aims to rapidly achieve maximal CHRs and molecular responses and minimize neoplastic cells carrying JAK2 mutations in order to suppress disease progression. |
Abbreviations: CHR, complete hematologic response; Hct, hematocrit; INF, interferon; MPN, myeloproliferative neoplasm; PD, progressive disease; PV, polycythemia vera.
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