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REVIVE phase II final results: Rusfertide in patients with polycythemia vera
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Preliminary results from the phase II REVIVE trial (NCT04057040) demonstrated that rusfertide, a novel hepcidin mimetic peptide, was superior to placebo in achieving hematocrit levels <45% in patients with PV. Final results from the three-part REVIVE trial were presented by Aaron T. Gerds at the 66th ASH Annual Meeting and Exposition.1 A total of 70 patients were enrolled in Part 1, 59 in Part 2, and 58 continued to Part 3.1 |
| Key learnings |
| Rusfertide demonstrated superiority over placebo in achieving the primary endpoint of hematocrit control without TP in Part 2 (69.2% vs 14.8%; p < 0.0001). |
| Hematocrit control <45% was consistently maintained with rusfertide for ≥3 years compared with placebo. The use of TP reduced after the initiation of rusfertide treatment. |
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According to MPN-SAF, rusfertide improved symptoms of fatigue (n = 20), early satiety (n = 13), abdominal discomfort (n = 9), inactivity (n = 12), problems with concentration (n = 14), night sweats (n = 11), and itching (n = 13) at the end of Part 3 (p < 0.05 each). |
| Grade 3 TEAEs occurred in 25.7% of patients and SAEs in 26% of patients; most were unrelated to the treatment. After ≥150 patient-years of rusfertide exposure, 11 patients reported malignancies. Seven thrombotic events occurred in six patients with high-risk PV. |
| Final results from the phase II REVIVE trial show that rusfertide ±CRT controlled erythrocytosis, provided long-term durable hematocrit control, and decreased the need for TP in patients with PV. Ongoing trials evaluating the safety and efficacy of rusfertide include phase II THRIVE OLE (NCT06033586) and phase III VERIFY (NCT05210790). |
Abbreviations: ASH, American Society of Hematology; CRT, cytoreductive therapy; MPN-SAF, Myeloproliferative Neoplasm Symptom Assessment Form; PV, polycythemia vera; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TP, therapeutic phlebotomy.
- Gerds A. Oral poster #4559. Final results from the phase 2 Revive study investigating the hepcidin mimetic rusfertide in patients with polycythemia vera (PV). 66th ASH Annual Meeting and Exposition; Dec 7–10, 2024; San Diego, US.
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