ECLIPSE-PV: A Randomized, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-Njft in Polycythemia Vera

Abstract

Introduction: Ropeginterferon alfa-2b-njft (ropeg) was approved and recommended as a preferred cytoreductive treatment for polycythemia vera (PV). The approved regimen requires an initial dose of 100 μg or 50 μg if transitioning from hydroxyurea (HU) and up-titrations of 50 μg every 2 weeks to 500 μg maximumly. The time to achieve the plateau dose takes approximately 20 weeks. This study compares the approved regimen with a higher initial dose and accelerated dose titration (HIDAT) regimen.

Methods: ECLIPSE-PV is a randomized, open-label, multicenter trial in patients with PV in the USA and Canada. Patients received ropeg either per the approved dosing schema or HIDAT regimen, i.e., 250 μg on day 0, 350 μg at week 2, and 500 μg from week 4 thereafter if tolerable. The primary endpoint is complete hematologic response (CHR) rate at week 24. CHR is defined as hematocrit <45%, white blood cells <10 × 109/L, platelets ≤400 × 109/L without phlebotomy in the previous 12 weeks. Secondary endpoints include molecular response, safety, tolerability, and quality of life.

Conclusion: A total of 111 patients were randomized and the last patient was enrolled on June 21, 2024. As of November 12, 2024, the discontinuation rate was 14.4%, and 16 patients (14.4%) completed the study. The study is expected to be completed in the summer of 2025. This is the first prospective trial comparing two dosing regimens of ropeg. The results will inform the optimal treatment strategy for patients with PV.

Keywords: Higher initiating dose; Phase 3b clinical trial; Polycythemia vera; Ropeginterferon alfa-2b-njft; Two dosing regimens.