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REVIVE trial meets primary endpoint: Significant improvements with rusfertide versus placebo

Apr 11, 2023
Learning objective: After reading this article, learners will be able to cite a new clinical development in polycythemia vera.

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Recent results from the phase II REVIVE trial (NCT04057040) investigating the hepcidin mimetic rusfertide compared with placebo in patients with polycythemia vera showed significant improvements in response rates in patients treated with rusfertide.1

A total of 53 patients from part 1 of the trial were enrolled in the blinded, placebo-controlled, randomized withdrawal portion of the trial (part 2) for a duration of 12 weeks.1 Of the enrolled patient cohort, 69.2% of patients recorded a response to rusfertide, in comparison with 18.5% of patients responding to placebo (p = 0.0003). Responders were defined as patients having completed 12 weeks of double-blind treatment while maintaining hematocrit control without phlebotomy. Moreover, during the 12-week period, 92.3% of patients remained phlebotomy-free (p = 0.0003).1

Rusfertide was well tolerated, with localized injection site reactions comprising the most common adverse events reported.1 No new safety signals were identified since the last report at ASH 2022 by Pemmaraju et al.2 For a summary of the currently reported treatment-related adverse events, check out this previous MPN Hub article.

Further analysis of this phase II trial and data from the phase III VERIFY trial (NCT05210790) will determine the role of rusfertide in the future treatment of patients with polycythemia vera.

  1.  Protagonist therapeutics announces highly statistically significant results from the randomized withdrawal portion of the REVIVE study of rusfertide in polycythemia vera. Published Mar 15, 2023. Accessed April 5, 2023.
  2. Pemmaraju N. Subgroup analysis of adverse events following rusfertide dosing in REVIVE: A phase II study of patients with polycythemia vera. Abstract #3040. 64th American Society of Hematology Annual Meeting and Exposition; Dec 11, 2022; New Orleans, US.


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