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ASH 2025 | FEDORA preliminary analysis: fedratinib plus ropeginterferon alfa-2b in patients with myelofibrosis
Adam Mead, MA, BM, BCh, MRCP, FRCPath, PhD, Oxford University Hospitals NHS Foundation Trust, Oxford, UK, discusses the preliminary analysis of the FEDORA study (ISRCTN88102629), a Phase II trial evaluating the combination of fedratinib and ropeginterferon alfa-2b in patients with myelofibrosis (MF). Dr Mead notes that results to date are encouraging, with the combination resulting in spleen responses, symptom improvement, and reduction in JAK2 allele burden. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So we’ve been running the FEDORA study in the UK for a number of years. This study is led by Mary Frances McMullin, who’s the chief investigator of the study, and we’ve been helping with some of the translational science associated with the study. So what this study is doing, which I think is really novel, is testing the combination of fedratinib with ropeginterferon...
So we’ve been running the FEDORA study in the UK for a number of years. This study is led by Mary Frances McMullin, who’s the chief investigator of the study, and we’ve been helping with some of the translational science associated with the study. So what this study is doing, which I think is really novel, is testing the combination of fedratinib with ropeginterferon. So patients are treated with one cycle of fedratinib. These are patients, I should say, with untreated myelofibrosis. They get one cycle of fedratinib, and then gradually ropeginterferon is introduced and gradually increased in dose.
So the purpose of the study is to establish the safety of doing this, which we have successfully established on the study. And this interim analysis gives us a sense of the likely efficacy, I think. So we’re seeing nice spleen responses, substantial symptom improvements. And I think one really exciting thing is the analysis that we’ve done in my laboratory where we’ve studied the JAK2 allele burden. We’re seeing very substantial reductions in the clonal burden of the disease in quite a few patients going on the study despite quite short follow-up. So that’s quite unusual in myelofibrosis and I think is very encouraging for this novel combination. Biologically what we think might be happening is the interferon may stimulate the quiescent stem cells into cycle, rendering them much more susceptible to JAK inhibition with fedratinib. And I would also draw attention to the work from McMilson that’s studying this in preclinical model systems, again showing strong synergy between interferon and fedratinib treatment.
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