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ASH 2023 | XPORT-MF-044 trial: evaluating selinexor in JAK inhibitor-naïve MF and moderate thrombocytopenia

Aaron Gerds, MD, Cleveland Clinic, Cleveland, OH, briefly introduces the Phase II XPORT-MF-044 (NCT05980806) trial, which will aim to evaluate the efficacy and safety of selinexor monotherapy in patients with JAK inhibitor-naïve myelofibrosis and moderate thrombocytopenia. This specific subset of patients will be used in order to add to the growing body of data on selinexor use in MF, ultimately broadening the spectrum of knowledge regarding the responses of different patient populations to this drug. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.

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Transcript (edited for clarity)

So selinexor has been around for some time. The folks who treat patients with multiple myeloma may be familiar with it, but it also has activity in myelofibrosis, and there’s been a Phase I/II trial looking at selinexor, mostly in the second-line setting. But there’s growing evidence that it is very active in the front-line setting as well, which would make sense that if it works in the second line it should also work in the front line as well...

So selinexor has been around for some time. The folks who treat patients with multiple myeloma may be familiar with it, but it also has activity in myelofibrosis, and there’s been a Phase I/II trial looking at selinexor, mostly in the second-line setting. But there’s growing evidence that it is very active in the front-line setting as well, which would make sense that if it works in the second line it should also work in the front line as well. And there are a couple of ongoing trials. There’s a large randomized Phase III trial that’s launched looking at selinexor in the front-line setting. This is going to be a Phase II trial, a little bit more of a focused study, looking at a certain subset of patients with blood counts that aren’t pristine, if you will. Because we want to get a totality of data here, we want to know how this drug functions in lots of different populations. A lot of the clinical trials that have been done in myelofibrosis pick very select populations and so the results are not widely applicable. And so if we test the drugs in lots of different populations and get a broader spectrum of who might receive this medication if it were available, it makes a lot more sense. And then we can use that information to apply to everyday practice and things like guidelines. So while this isn’t the, you know, the marquee Phase III randomized controlled trial, it is nonetheless a very important study because it will add to the totality of data as we look at selinexor as an agent in myelofibrosis.

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Disclosures

Consultancy: AbbVie, Bristol Myers Squibb, Constellation Pharmaceuticals, GlaxoSmithKline, Kartos, Novartis, PharmaEssentia, Sierra Oncology
Research Funding: Accurate Pharmaceuticals, Constellation Pharmaceuticals, CTI BioPharma, Imago BioSciences, Incyte Corporation, Kratos Pharmaceuticals