THRIVE phase II extension: Long-term rusfertide treatment in PV

Results from the phase II THRIVE (NCT06033586) extension study evaluating the long-term efficacy and safety of rusfertide treatment in patients with polycythemia vera (PV) were presented during the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US, by Naveen Pemmaraju. Of 58 patients who completed the prior REVIVE study, 46 transitioned to THRIVE, receiving subcutaneous rusfertide once weekly with or without cytoreductive therapy (CRT). 

Key data: At data cutoff, 44 of 46 patients (96%) remained on study. The median treatment duration across REVIVE and THRIVE was 196 (154–267) weeks. Mean hematocrit (Hct) remained stable at 42.3% (standard error of the mean [SEM], 0.54) at the end of REVIVE and 43.0% (SEM, 1.34) at Week 60 in THRIVE. The mean annualized therapeutic phlebotomy (PHL) rate decreased from 9.2 (SEM, 0.77) PHL/year prior to REVIVE entry to 0.7 (SEM, 0.17) PHL/year during THRIVE. The most common adverse events (AEs) were Grade 1–2 injection site reactions (87%), fatigue (61%), and COVID-19 (52%). There were no Grade 4 treatment emergent AEs or deaths reported during THRIVE.

Key learning: Continued rusfertide treatment with or without CRT demonstrated consistent, long-term Hct control with reduced PHL needs compared with baseline. With a median treatment duration of 196 weeks, rusfertide’s safety profile remained consistent with prior observations, supporting its use in the management of patients with PV.