The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: A few on povorcitinib and then a couple on Opzelura, please? First, for Dr. Kwatra on povorcitinib. How do you think about the safety
profile here, specifically the serious treatment-emergent adverse events and the grade 3 plus treatment-emergent AEs? What were
those? And I guess, overall, is the safety profile acceptable to you? And then while we're on povorcitinib, I think you mentioned that
elevated blood eonosinophils predict response to dupi. Is that the case for other therapies too or thought to be the case? And with
that in mind, I noticed that baseline demographics weren't broken out by treatment arm. Were the racial demographics balanced
in this trial? And what about the other baseline demographics?
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MARCH 11, 2024 / 4:00PM, INCY.OQ - Incyte Corp to Discuss the Key Data Presentations at AAD
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Yes. It was on the elevated eosinophils, predicting response to dupi and whether we think that's the case for other therapies, given
that I think you said that those are elevated more so in Caucasian and Asian patients. And so with that in mind, were the racial
demographics balanced in the povorcitinib trial? And what about the other baseline demographics? Because it looks like the data
is provided on a pooled basis.
Shawn Kwatra
Yes, that's a great question. So the -- all clinical trials right now have more Caucasian patients and less skin-of-color patients. So that's
not unique to this trial, that's every trial. The HS trial had very high numbers of African-Americans actually higher than the population
prevalence. So we're.
Martina Porter
We're going crazy trying to get...
Shawn Kwatra
Yes. But there was no imbalances, but that's consistent with the dupilumab and nemo arms. For the elevated eosinophils, I mean,
we just found it and this group in China just found it. So now we're trying to look at it. We have no idea with nemolizumab.
But I will say, if you look at some of the AEs, you have -- you can see how the cookie is crumbling. So nemo, you have some AEs for
eczematous events, either eczematous or eczema, it's a small percentage, it's managed by. But for dupi and (inaudible) too, what
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MARCH 11, 2024 / 4:00PM, INCY.OQ - Incyte Corp to Discuss the Key Data Presentations at AAD
we're seeing is there's an immune switching phenomena where then you're getting -- I have a few patients who have a [story as a
forum] phenomena. We know about head and face neck dermatitis in our lab studying this. So what we think is IL-4 receptor alpha
actually upregulates Th117 responses, which may actually harden some of those different pathways in PN patients.
And then with nemo there may be very mild, but there may be some effect in subsets of patients with the eczematous derm as well.
So we have some kind of insights into it. I would expect that you have very good efficacy in both groups with this molecule because
we know it's IL-22 interferon gamma IL-6, and JAK1 hits all those. So that would be my hypothesis, but we'll look at it in the translational
data.
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: And can I ask a couple on Opzelura?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: On the explanation of the different rates of dropout in the Opzelura arm not being explained by those with more nodules at baseline,
is that to say that there were disproportionately high dropouts from the Opzelura arm versus placebo in the milder patients? And
then what might explain that? And then secondly, for Opzelura and HS, it looks like the HiSCR didn't separate until week 16, and I'm
curious about the time course of the AN50, 75, 90, et cetera, response criteria. Did those also not separate until week 16?
Martina Porter
Well, sort of a heads like you were saying, we haven't cut all the data that way yet to -- so I don't know the answer about the separation
for the AN50, 75, 90 by week. I can tell you for the dropout, let me just see, wait a sec here. Oh, there it is. Thanks. Yes. So the dropout
was the same between the vehicle and the rux cream for the moderate patients, which we define in the 5 to 10 arm, and the delta
there was different and it had a very similar pattern that we saw at week 8 where they were separating. The milder patients is where
all of the dropout essentially occurred almost.
And of those patients, some of them -- well, there was a big portion of them, 5 that were lost to follow-up, and all 5 of those patients
were of the same racial demographic. And it wasn't clear why those patients dropped out. And it could be that they were not
experiencing much improvement because they started out with only 3 or 4 lesions and their expectation was to be clear. And so I
think it's a little bit difficult to really tease out with such a small dataset if these trends will carry forward to a larger trial.
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MARCH 11, 2024 / 4:00PM, INCY.OQ - Incyte Corp to Discuss the Key Data Presentations at AAD
But also, I would say the other thing is, in this study, if you started as mild and you're only treating one area where you had those
lesions and something pops up elsewhere, then you're artificially also seeing fewer changes because there's no way or, in my opinion,
no expectation that treating an area at a distant site would have prevented those lesions from popping up elsewhere.
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