Fedratinib shows strong results for previously treated patients with myelofibrosis
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SAN DIEGO — Treatment with fedratinib led to “superior” spleen volume reduction and symptom response rates in patients with myelofibrosis previously treated with ruxolitinib, according to data presented at ASH Annual Meeting and Exposition.
The results from the phase 3 randomized FREEDOM2 study highlighted “a clinical need for an alternative JAK inhibitor,” according to data published by a team led by Claire N. Harrison, MD, professor at Guy's and St. Thomas' Hospital in London.
Patients with myelofibrosis treated with ruxolitinib (Jakafi, Incyte) have previously displayed positive results in their spleen volume reduction and symptom response rates, but over time have become known to become resistant to the treatment, and have documented poor relapse/refractory results and survival rate after discontinuing the treatment.
In the FREEDOM2 study, a phase 3, open-label, randomized study, a total of 134 patients were treated with fedratinib (Inrebic, Bristol Myers Squibb) as opposed to 67 in the best available treatment arm, most of whom were treated with ruxolitinib. The median age was 70 years and 52% were men.
At the data cutoff, 35.8% of patients in the fedratinib arm had reached the primary endpoint of 35% spleen volume reduction — as opposed to just 6% of the best available treatment arm — and had much stronger overall spleen volume reduction rates by the end of cycle 6.
Although 81.3% of the patients in the fedratinib arm experienced some kind of treatment-related adverse event by the end of cycle 6, the study reported that mitigation efforts were “effective” and no new safety concerns for fedratinib were observed.
The study also noted that the differences in adverse events and discontinuation rates between JAK inhibitors and best available treatment remained consistent with other studies.
Reference:
- Harrison CN, et al. Efficacy and safety of fedratinib in patients with myelofibrosis previously treated with ruxolitinib: Results from the phase 3 randomized FREEDOM2 study. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2023; San Diego.
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