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A new meta-analysis confirms ropeginterferon alfa-2b (Besremi) outperforms phlebotomy alone in polycythemia vera, but falls short of proving superiority over the standard drug hydroxyurea. Pooling data from three randomized trials, researchers found stronger hematologic and molecular responses vs. phlebotomy, while results vs. hydroxyurea were statistically similar. Authors still back its role as a disease-modifying therapy, especially for low-risk patients.
A systematic review and meta-analysis presented at the 2026 Society of Hematologic Oncology (SOHO) Annual Meeting found that ropeginterferon alfa-2b (Besremi) significantly outperformed phlebotomy alone in treating polycythemia vera (PV), but did not demonstrate a statistically significant edge over hydroxyurea across key efficacy measures.
Drawing on three randomized controlled trials — Low-PV, PROUD-PV, and CONTINUATION-PV — researchers evaluated complete hematologic response (CHR), partial molecular response (PMR), and JAK2 V617F allele burden reduction. Against phlebotomy, ropeginterferon alfa-2b showed clear wins on all three fronts. Against hydroxyurea, however, pooled results were statistically similar, with substantial heterogeneity limiting the strength of conclusions. Despite this, the authors argue the drug's molecular and hematologic profile supports its use as a disease-modifying therapy, particularly in low-risk patients.
By the Numbers
Why it matters: Ropeginterferon alfa-2b received FDA approval for PV in 2021 and for essential thrombocythemia in 2026. This meta-analysis reinforces its value over phlebotomy but highlights the need for longer, larger trials to definitively establish its standing relative to hydroxyurea.