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FREEDOM2 subanalysis of fedratinib in patients with MF: ASH 2024 update
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A subanalysis of the open-label, multicenter, randomized, phase III FREEDOM2 trial (NCT03952039) further assessed the safety and efficacy of fedratinib, a Janus kinase inhibitor, vs best available therapy in patients with MF previously treated with ruxolitinib with either a low (n = 55) or high (n = 124) baseline platelet count.1Results were presented during the 66th ASH Annual Meeting and Exposition by Al-Ali.1 |
| Key learnings |
| At Cycle 1 Day 15, patients with a low baseline platelet count had a greater initial increase in platelet count with fedratinib vs BAT (+45% vs +11%), which was maintained for ≥2 months, and patients with a high baseline platelet count showed a greater early platelet count increase with fedratinib vs BAT (+27% vs −6%). |
| At the end of Cycle 6, fedratinib improved SVR35 and SVR25 rates vs BAT in both patients with low (SVR35, 47% vs 0%; p = 0.0001; SVR25, 53% vs 5%; p = 0.0003) and high (SVR35, 35% vs 10%; p = 0.0043; SVR25, 48% vs 18%; p = 0.0014) baseline platelet counts. |
| Grade 3/4 AEs during the first six treatment cycles were higher among patients with a low baseline platelet count (fedratinib arm, 76.5%; BAT arm, 57.1%) compared with patients with a high baseline platelet count (fedratinib arm, 61.2%; BAT arm, 13.3%). Rates of Grade 3/4 hematologic TEAEs were similar with fedratinib and BAT treatment. |
| Results from this analysis suggest a platelet-sparing effect of fedratinib vs BAT, supporting the use of fedratinib as a second-line therapy for patients with MF, irrespective of baseline platelet count. |
Abbreviations: AE, adverse event; ASH, American Society of Hematology; BAT, best available therapy; MF, myelofibrosis; SVR, spleen volume reduction; TEAE, treatment emergent adverse event.
- Al-Ali HK. Efficacy and safety of fedratinib in patients with myelofibrosis and low baseline platelet counts in the phase 3 randomized FREEDOM2 trial. Oral abstract #482. Presented at: 66th American Society of Hematology Annual Meeting and Exposition; Dec 8, 2024; San Diego, US.
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