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EHA 2021 | JAKARTA & JAKARTA2: PFS and OS with fedratinib in myelofibrosis

Ruben Mesa, MD, UT Health San Antonio MD Anderson Cancer Center, San Antonio, TX, discusses an analysis evaluating progression-free survival (PFS) and overall survival (OS) in patients treated with fedratinib as first-line myelofibrosis therapy and after prior ruxolitinib in the JAKARTA (NCT01437787) and JAKARTA2 (NCT01523171) studies. Results from both the JAKARTA and JAKARTA2 studies suggest that fedratinib significantly improves PFS and OS in patients with myelofibrosis. Prof. Mesa comments on the findings of these studies and discusses growing evidence to suggest the benefit of Janus-kinase-1/2 (JAK-1/2) inhibition in improving symptoms and survival in patients with myelofibrosis. This interview took place at the virtual European Hematology Association (EHA) Congress 2021.

Transcript (edited for clarity)

Fedratinib is a JAK inhibitor, oral JAK2/JAK1, has impact on FLT3. We had the large JAKARTA randomized Phase III trial versus placebo and in the JAKARTA-2 study, a second-line study led by Professor Harrison and I. At this year’s EHA meeting, Professor Harrison demonstrated a analysis on both progression-free survival and overall survival with JAKARTA-1 and JAKARTA-2.

In JAKARTA, that was a trial that the length of follow-up is somewhat limited because of the cessation of that trial at that point in time due to the concerns of Wernicke’s encephalopathy...

Fedratinib is a JAK inhibitor, oral JAK2/JAK1, has impact on FLT3. We had the large JAKARTA randomized Phase III trial versus placebo and in the JAKARTA-2 study, a second-line study led by Professor Harrison and I. At this year’s EHA meeting, Professor Harrison demonstrated a analysis on both progression-free survival and overall survival with JAKARTA-1 and JAKARTA-2.

In JAKARTA, that was a trial that the length of follow-up is somewhat limited because of the cessation of that trial at that point in time due to the concerns of Wernicke’s encephalopathy. All of that said, with the data we are able to analyze it and see that there is strong evidence of an impact of fedratinib on improvements in progression-free survival with, in JAKARTA, as well as a suggestion of overall survival improvement as well, even accounting for the limitations of length of follow-up on the medication. With JAKARTA-2, we similarly see data suggesting, compared to recently published data regarding second-line therapies in myelofibrosis, likely improvement in both progression-free and overall survival.

So, I think that this is important data and I think it’s also consistent data. That, increasingly, we’re seeing that benefit with JAK inhibition have clearly been demonstrated to improve survival with ruxolitinib. As I presented at this meeting, I think clearly, we’re having benefit in terms of survival with momelotinib, particularly in patients who receive, who have transfusion independence. And it stands to logic, that we see improvements in survival with fedratinib as well.

I think JAK inhibition remains an incredibly important part of therapy for patients with myelofibrosis. I would anticipate as data matures, we likely will see a similar benefit in survival with pacritinib, and that as we look at the future of myelofibrosis single and combination therapies, I think JAK inhibition will remain an important cornerstone of, at a minimal, doublet-type therapies when appropriate because of their impact on survival.

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Disclosures

Ruben Mesa, MD, has participated in a consultancy role with Novartis, Sierra Onc, LaJolla, Pharma and Constellation; and has received research support from Celgene, Incyte, Abbvie, Samus, Genotech, Promedior, CTI and Constellation.