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: Jess Fye - JPMorgan - Analyst
: Great. Thanks for the presentation. I have a couple of commercial questions, although most of the presentation was really about the
pipeline. Herve, just want to ask about Jakafi heading into 2025 as we think about the Part D redesign continuing to be implemented
here. What is that impact this year? Should we think of that as a tailwind? And if so, is it possible to quantify?
Question: Jess Fye - JPMorgan - Analyst
: Maybe sticking with the Jakafi franchise, what about once-daily rux? I feel like we've kind of made some progress since the initial
regulatory setback. What's the IP for that asset? And how are you thinking about the magnitude of revenue you could preserve after
the LOE kind of original Jakafi?
Question: Jess Fye - JPMorgan - Analyst
: What about Opzelura? We see these scripts every Friday, it looks like they had kind of a nice uplift towards the end of the year.
Question: Jess Fye - JPMorgan - Analyst
: What's driving that growth here. Is it which indication kind of --
Question: Jess Fye - JPMorgan - Analyst
: I think in the past you've refrained from giving a peak sales guidance for Opzelura, but you said very, very meaningful. You want to
put any brackets around that or --
Question: Jess Fye - JPMorgan - Analyst
: Maybe shifting to povorcitinib, which I think could be the next pipeline readout. What level of detail should we expect with the
Phase III top line results in HS? And I guess, what would define a competitive or a differentiated profile?
Question: Jess Fye - JPMorgan - Analyst
: So you mentioned that the data so far stacks up well against biologics. But how does povorcitinib's data so far compared to AbbVie's
RINVOQ in either HS or vitiligo? And how do you think about the competitive dynamics with RINVOQ in those settings if they're both
approved?
Unidentified Company Representative
So let's remind everyone first. The theoretical -- it's not theoretical, the preclinical, differences. So povorcitinib is a more selective
JAK1 inhibitor, is more potent. It has a very large volume of distribution, which we think is related to the concentrations in achieved
(inaudible).
And when you put side-by-side the data in HS, I think it's pretty clear that the data we've generated with povo is superior. The
placebo-substracted data at -- when you look again at every endpoint and every time point, is superior to the RINVOQ data, so far.
Now we're both running Phase III programs, and we'll see how those programs replicate the randomized Phase II data.
So I'll go back to the same answer, Jess, which is I think we have a product today that looks as the best oral for patients with HS, and
I would argue as well for PN and for vitiligo. And we can talk about PN particularly, which I think it's really important how
well-differentiated povo potentially is. And we think if we replicate that data, we're going to be in a very good position. I don't know
if Herve wants to comment on the commercial landscape when it comes to competition with RINVOQ.
Question: Jess Fye - JPMorgan - Analyst
: So you also flagged the Phase II proof-of-concept studies coming up, right? For CSU and for moderate severe asthma with povo.
What do you need to show there? What would be encouraging and where would you see this molecule fitting into those respective
treatment paradigms?
Question: Jess Fye - JPMorgan - Analyst
: Maybe to switch to the [CDK2], you kind of outlined the menu of late-stage development options.
Question: Jess Fye - JPMorgan - Analyst
: You're doing all?
Question: Jess Fye - JPMorgan - Analyst
: Okay.
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JANUARY 13, 2025 / 6:30PM, INCY.OQ - Incyte Corp at JPMorgan Healthcare Conference
Question: Jess Fye - JPMorgan - Analyst
: Got it. And when do we get the next update on the ongoing trial to get a little better insight into the possibility of taking forward
that accelerated approval trial?
Unidentified Company Representative
We haven't made that decision. I think as we continue to move the pivotal plan forward, we're planning an update at some point.
But we haven't decided exactly when that's going to be. I mean we presented a very meaningful update on ESMO, let's remember.
We presented over 200 patients, a range of doses, some different schedules, a very comprehensive safety database and clear evidence
of activity, which Herve reminded everyone with the waterfall plot today.
So I think the picture is clear. We have an active agent with a response rate in the 25% to 30%. A lot of stable diseases, and some
very durable, which we think it certainly supports the potential approval in platinum-resistant disease. The combination with
bevacizumab has started. We're going to have that data over the course of the year. We think we just need safety to discuss that
with regulators and make sure they agree.
I think the important thing about (inaudible) is not just that it's obviously more impactful for patients, is a larger patient population
and it's a very long duration of therapy. If you look at the last 15 years, the PFS in those patients, depending on the specifics of the
eligibility criteria and what they receive, is between 15 and 20 months. It's very long duration of therapy. That makes it for a very
large commercial opportunity if we demonstrate efficacy in that setting.
And I want to make sure we don't forget about endometrial cancer. We showed several responders at ESMO as well. We have every
intention to continue to figure out how to develop our CDK2 in endometrial cancer, which I think it's an important opportunity.
And we are doing a lot of work in breast cancer. We haven't discounted it. Obviously, the competition there is different because
companies with CDK46 franchise are really going very hard after that particular setting. But we are running combination studies
with chemotherapy with PARP inhibitors and with hormonal therapy in order to understand what our path could be in patients with
breast cancer as well.
Question: Jess Fye - JPMorgan - Analyst
: What's the bogey on allele burden?
Unidentified Company Representative
I think there's a bogey. Look, if you look at the most recent release, it was last week with interferon in ET, the reduction in allele
burden of VAF was 8%. I'm not putting that as a benchmark, let's make that very clear. The bottom line is existing therapies very
modestly reduce VAF, variability of fraction, in a very small percentage of patients. So small percentage of patients, small percent
reduction. We think we can change that. But I'm not going to put a number yet.
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