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A New Horizon for JAK Inhibitors: Revivals and Continued Study

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Published on January 24, 2018

What have dedicated MPN researchers learned recently about JAK and JAK2 inhibitors? At the 2017 American Society of Hematology (ASH) annual meeting, a panel of MPN experts including Dr. Ruben Mesa from the UT Health San Antonio Cancer Center, Dr. Rami Komrokji from Moffitt Cancer Center, and Dr. Jamile Shammo from Rush University Medical Center, joined Patient Power to discuss the news presented at ASH related to these therapies. Watch now to find out the latest news about up-and-coming MPN treatments including the revival of a previously studied treatment, fedratinib.

Sponsored by Incyte Corporation.

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Transcript | A New Horizon for JAK Inhibitors: Revivals and Continued Study

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That's how you’ll get care that's most appropriate for you.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Dr. Mesa:                    

The other thing I would highlight is quite a bit more subtle. And it’s a poster that Claire Harrison and myself, Catriona Jamieson are presenting today on fedratinib. So fedratinib, the long-forgotten JAK2 inhibitor…

Andrew Schorr:          

Had it been stopped? 

Dr. Mesa:                    

It had been stopped. It was a drug that had a very favorable set of clinical trials and was about to be approved. And it ran into a roadblock that there was a concern about a neurologic complication that’s rare that’s called Wernicke’s encephalopathy. So, that basically took a drug that was about to be approved, there were hundreds of patients on the drug, and it stopped it cold.

So, what our little poster here is actually about removing the log-jam really regarding fedratinib. So, with a lot of analysis—there were eight patients in question out of almost 900—they brought in neurologists, other specialists, and found that of the eight, seven did not have Wernicke’s encephalopathy. It just took time to sort that out.

The one individual that did have Wernicke’s, in fact, had Wernicke’s before the trial started. So, perhaps it worsened it, perhaps it was just chance. So, with that the FDA has taken a hold off the medication, and there is a companytrying to move that drug forward. So, that resolving of that issue might well lead to an approval of a new JAK inhibitor, even in a short amount of time, because all of that information from those studies that many of us participated in is still there.

Andrew Schorr:

So, Rami—when you hear about that—let me make sure we understand. So you’ve had ruxolitinib (Jakafi)—works for a lot of people, doesn’t work for everybody, both in some PV and in certainly myelofibrosis. So, would this be helpful, to have…

Dr. Komrokji:              

...oh, absolutely. So, as I mentioned earlier, I think we know that ruxolitinib now is available therapy that helps a lot of patients. There is an issue when ruxolitinib stops working, and that’s well known. Like I think recently there had been publication looking at the clinical studies, what happens after ruxolitinib failure? We published our experience also, looking at that in real-life experience. 

There are limited options for patient treatment. And most of them actually don’t work well. So there’s definitely need for second JAK2 inhibitor. And whether it’s pacritinib or fedratinib, there have been some results suggestive that you could respond to second JAK2 inhibitor after failure of the first one. And indeed, in the fedratinib studies originally—which we have plenty of that and its efficacy. As Ruben mentioned, we know the drug is active. The hold was because of worry about toxicity. 

So we’ve known that about its efficacy as first-line, but we know also that there is subset of patients that receive fedratinib after ruxolitinib failure, and they have responses. So if we can resolve the toxicity issue, I think this is going to be an option available for the patients in the near future. So this is exciting.

Andrew Schorr:          

Fedratinib—now Jamile, have you been involved at all—I know there are now trials beginning again in pacritinib. Are you involved in that at all? 

Dr. Shammo:               

Yes, we are. 

Andrew Schorr:          

Okay. So, tell us about that, because that had been held too.

Dr. Shammo:               

Yes. Indeed. And there was some concern about bleeding events, because I guess the drug was found to be efficacious in patients who have low platelet count, in which case you may not be able to utilize ruxolitinib to its fullest potential. But the problem, again, was bleeding events. 

So, I guess, again, after the FDA put it on hold, and then they sort of reviewed the data, the ultimate decision was made to sort of let the clinical trials go on, albeit with three different dosing intensities. And it’s looking also at a patient population in whom ruxolitinib has either failed or those patients had it and then they progressed. So, it will be really interesting to see exactly the dose that might be most effective. 

And of course, the one that has the least potential for side effects. Because obviously, yes, you want to control the disease, but you also realize that you want people’s quality of life to be relatively preserved while on therapy. So, that’s hopefully going to be upcoming. 

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.