All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the MPN Advocates Network.
The MPN Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
Introducing
Now you can personalise
your MPN Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe MPN Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the MPN Hub cannot guarantee the accuracy of translated content. The MPN Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The MPN Hub is an independent medical education platform, sponsored by AOP Health and GSK, and supported through an educational grant from Bristol Myers Squibb. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
FREEDOM-2: Primary analysis of the efficacy and safety of fedratinib in MF
Bookmark this article
|
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
Your opinion matters
9 votes - 2 days left ...
Related articles
Newsletter
Subscribe to get the best content related to MPN delivered to your inbox