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ROP-ET phase III preliminary results: Ropeginterferon alfa-2b for ET
During the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US, Jean-Jacques Kiladjian presented preliminary results from the phase III ROP-ET trial (NCT06514807) evaluating the safety and efficacy of ropeginterferon alfa-2b in patients with essential thrombocythemia (ET) who were intolerant to, resistant to, and/or ineligible for approved cytoreductive therapies (N = 132). The primary endpoint was durable (≥3 months) hematologic and clinical response after 12 months.
Key data: At 12 months, 48.0% (95% confidence interval [CI], 39.1–57.1) of patients achieved durable (≥3 months) hematologic and clinical response based on modified European LeukemiaNet (ELN) criteria, exceeding the historical response rate of 40%. Additionally, 87.7% of patients showed improvement or non-progression of symptoms compared with baseline. Treatment-related adverse events (TRAEs) were mostly mild (Grade 1, 68.9%), with 5.3% of patients experiencing Grade ≥3 TRAEs, and 2.3% discontinuing treatment.
Key learning: Ropeginterferon alfa-2b demonstrated efficacy and safety in patients with ET who are intolerant to, resistant to, and/or ineligible for standard cytoreductive therapies, representing a favorable therapeutic option.
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