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FREEDOM-2: Primary analysis of the efficacy and safety of fedratinib in MF
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The MPN Hub previously reported on the study design and early data from the phase III FREEDOM2 (NCT03952039) trial, which investigated the safety and efficacy of fedratinib vs BAT in patients with MF treated with ruxolitinib. A total of 201 patients were randomized; 134 received fedratinib and 67 received BAT (including 52 who were receiving ruxolitinib); 46 patients from the BAT group crossed over to fedratinib. We summarize key findings from the primary analysis of the trial published by Harrison et al. in The Lancet Haematology. |
| Key learnings |
| Fedratinib demonstrated superior SVR35 at the end of Cycle 6 compared with BAT (36% vs 6%; p < 0.0001). |
| GI AEs were frequent in the fedratinib group but were primarily Grade 1–2 in severity. Grade ≥3 events (including anemia and thrombocytopenia) occurred in 40% of patients in the fedratinib group compared with 12% in the BAT group. Prophylactic use of antiemetics, thiamine, and antidiarrheals was effective in managing these effects. |
| Low thiamine levels were more frequent in the fedratinib compared with the BAT group (21% vs 4%), but were manageable with prophylactic supplementation, reducing the severity compared to previous trials. |
| These findings demonstrate that fedratinib presents a viable second-line treatment for MF after ruxolitinib failure, with effective strategies to mitigate GI side effects and thiamine deficiency, potentially improving patient outcomes in this high-risk group. |
Abbreviations: AE, adverse event; BAT, best available therapy; GI, gastrointestinal; MF, myelofibrosis; SVR35, spleen volume reduction.
- Harrison CN, Mesa R, Talpaz M, et al. Efficacy and safety of fedratinib in patients with myelofibrosis previously treated with ruxolitinib (FREEDOM2): Results from a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Haematol. 2024;11(10):e729-e740. DOI: 1016/S2352-3026(24)00212-6
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