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On Tuesday, 11 March 2025, Incyte Corporation (NASDAQ: INCY) presented its strategic plans at the Leerink Global Healthcare Conference 2025. The company highlighted a robust growth strategy, marked by a 15% revenue increase in 2024, while also addressing challenges such as competition in its core drug markets. Incyte’s focus remains on innovation and extending the lifecycle of its key products, with significant reinvestment in research and development.
Key Takeaways
- Incyte reported a 15% revenue increase in 2024, reaching $4.2 billion, with a strong focus on R&D reinvestment.
- Jakafi remains a cornerstone drug, with strategies to extend its market exclusivity through Jakafi XR.
- The company is advancing its pipeline with novel therapies for mutant CALR and 670F mutations.
- Absolura is gaining traction in atopic dermatitis and vitiligo, despite mixed results in prurigo nodularis trials.
- Povo, a promising oral JAK inhibitor, is progressing towards phase 3 data for hidradenitis suppurativa.
Financial Results
- Incyte achieved a 15% increase in revenue for 2024, amounting to $4.2 billion.
- Significant reinvestment in R&D is aimed at supporting future growth and innovation.
Operational Updates
- Jakafi continues to perform well in myelofibrosis (MF), polycythemia vera (PV), and graft-versus-host disease (GVHD).
- The launch of Nictimbo is expected to bolster the GVHD franchise alongside Jakafi.
- Jakafi XR is anticipated to launch in mid-2026, aiming to extend market exclusivity by transitioning patients to a once-a-day formulation.
- Incyte is developing a BET inhibitor for potential co-formulation with Jakafi, showing positive safety and efficacy data.
Future Outlook
- Incyte is developing therapies targeting mutant CALR and 670F mutations, with potential for disease modification and functional cures.
- Absolura is building a new franchise in vitiligo and atopic dermatitis, with successful market entry in Europe.
- The company is optimistic about Povo’s potential in hidradenitis suppurativa, with phase 3 data expected soon.
- Incyte’s CDK2 inhibitor program is advancing, targeting ovarian cancer with promising single-agent activity.
Q&A Highlights
- Herve Urbapenow emphasized Incyte’s commitment to innovation and geographic expansion.
- Pablo Canoni discussed the anticipated launch of Jakafi XR and the strategic importance of extending product lifecycles.
- The company expressed confidence in Povo’s role in treating hidradenitis suppurativa based on phase 2 data.
Incyte’s presentation at the Leerink Global Healthcare Conference 2025 showcased a balanced approach to growth and innovation. For a detailed review, refer to the full conference call transcript below.
Full transcript - Leerink Global Healthcare Conference 2025:
Andy Behrens, Senior Biotech Analyst, Leerink: afternoon, everyone. Andy Behrens, senior biotech analyst at Leerink. Welcome to day two of our global healthcare consents in beautiful Miami. We are very excited to have with us, InSite.
We have Urbapenow and Pablo Canoni from InSite. Thank you, gentlemen, for joining us.
Herve Urbapenow, InSite: Thank you for inviting us.
Andy Behrens, Senior Biotech Analyst, Leerink: For those not familiar with the company, can you just give a general overview of where you’ve been and
Herve Urbapenow, InSite: the focus going forward? So insight is about innovation. I mean, if you think of really what we are doing, it’s a company that is growing, it’s a company that is expanding geographically, expanding in term of portfolio of product in on the commercial side and R and D and reinvesting a proportion of this revenue into our own R and D. So in 2024, we grew at around 15% that was that led us to a revenue of $4,200,000,000 in 2024. And we reinvested in the pipelines that hopefully we can speak about, which we’ll be delivering a number of launches in the short term, a number of new Phase III study we are initiating this year and a number of proof of concept studies that also will be coming this year.
So 2025 will be a year where a lot of the visibility on the pipeline will improve because we get approval, we get a number of new data that will be important. And it’s a year where we will continue to grow through the new launches that we have and the growth of Jakafi and Otsilwar. That’s sort of the picture of insight today.
Andy Behrens, Senior Biotech Analyst, Leerink: Great. Well, thank you, Herve. We will certainly talk about Jakafi, but I think that companies definitely entered a period where there’s pipeline assets. People are very excited about it. I want to hear about those.
Why don’t we start, I guess, with Jakafi since that’s really been the backbone of the company. What are you seeing in the core indications? There have been a number of new drugs that have been approved, but JAKAFI seems to be continuing to do very strong. So what’s the commercial dynamic there from competition?
Herve Urbapenow, InSite: So there are three indication where JAKAFI is used mostly. It’s MF, PV and GVHD. So in GVHD, we launched just a few years ago. We are still growing at a reasonable rate. It’s a disease where most patients will be cycling between different products, and we were very happy to be able to launch a new product this year, Nictimbo just a few weeks ago that that we’ll be adding to the franchise in GBHD.
So the GBHD part now is becoming a franchise game where obviously, we want to continue to grow Jakafi, but we want to combine with Nick Timvo, and also we want to grow Nick Timvo as a single agent by itself. So that’s a sort one of the franchises that is growing and where there is a lot of promise to continue to grow for the long term with NIktinvo. In myelofibrosis, Jakafi is the standard of care. There were some number of new JAKs that have been introduced over the years like fedratinib and pakritinib and momelotinib. But that did not move the status of Jakafi because it’s the only JAKs that has shown survival benefit and long term benefit.
And it’s a product that is very well tolerated with a high level of response. And it has been in spite of all of this new competition, it has been keeping its position as a standard of care in first line. And then many of the other products are used in subsequent lines of therapy. And that’s what we have seen recently. So we see that as the slowest growing part of the brand for the long term because by definition, more patients are already treated with Jakafi, but it continued to grow last year, single digit kind of growth, but it was good.
And then there is PV. So PV is a place where polycythemia vera where Jakavi is also the standard of care, but many patients are just not receiving treatment yet. And here we are in a sort of a market expansion mode where the goal is to make sure that patients are appropriately treated early in their disease because we have shown in data that was available like two years ago that in fact you can improve thrombosis free survival if you treat earlier. And what we have seen is that, that part of our Jakavi franchise has been growing faster than the other two, and it’s now going to become the largest indication for Jakavi in the next few years. Great.
Andy Behrens, Senior Biotech Analyst, Leerink: A concern of investors has been, Jakavi has been very successful, but all successful drugs, they eventually lose patent exclusivity. Maybe we could talk a little bit about your efforts to extend the IP through the Limber trial. You just had some positive top line results from a bioequivalence trial, with Jakavi XR. So maybe we could talk about the strategy there.
Herve Urbapenow, InSite: Can you speak about the data on XR?
Pablo Canoni, InSite: Yeah. We can talk we can we can start there. As you know, part of the program was to develop a once a day formulation of Jakafi. That’s we call it XR. And we run a bioequivalency trial with fifty five milligrams a day.
We met bioequivalency. We reported the data at the last earnings call. We discussed the data obviously with FDA. We submitted top line data. And based on those conversations with FDA, we decided now to move forward towards the end of the year with the submission for an approval.
We need stability for the new tablets. So they are being manufactured on stability. Once the date comes, which is later this year, we’ll submit that. So that’s an important part of the story because obviously we have plenty of time assuming a six month review because this is a response to a complete response letter, if you remember. Assuming a six month review timeline, we think sometime in middle of twenty twenty six, we’ll be able to launch once a day Jakafi.
And that will give us about two point five years before the LOE to restart every patient, every new patient, ideally, with MF and PV, ideally, obviously, graphite associates as well on once a day formulation. And if you remember, the average duration of therapy for NMF patients is about two years and for a PV patient is about, you know, forty, forty six months. That would imply that a lot of the patients when the LOE comes will be on once a day branded Jakafi. And we think that not all of them will be switched to generic abruptly like it would happen otherwise. So that will, in a way, smoothen the cliff a little bit on the back end after the LOE.
That’s part of the strategy.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. And the other part is potentially co formulation?
Pablo Canoni, InSite: Yes. Indeed. So the one piece of data we updated everyone at the end of last year at ASH was our BET inhibitor data. We presented more safety and efficacy data with single agent and in combination with Jakafi. What we’ve said recently at the earnings call is we’re now pushing forward with the second line study with single agent BET in combination with best available therapy.
We think that’s a very important for the population of patients that either progress or intolerant to Jakafi to really have an option. And so that’s going to be a second line trial. We are doing additional work in first line in combination with Jakafi. Jakafi. We haven’t made a decision yet as to whether we’re going to move into first line.
If we do, obviously, we have the option to either co formulate or co package with once a day Jakafi.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. And part of the issue I think with other BETA inhibitors has been Jakafi does improve symptoms very dramatically, and and improving on that is a is a high hurdle. Do you think that there’s any, potential to convince the FDA to not require TSS scores? Or is that something that they just are not convinced that splenic reduction is enough to
Pablo Canoni, InSite: Yeah. Our assumption today is that you still need both endpoints or both components for an approval. The data we disclosed, if you look at our main competitor, as you all know, is Pelabrasiv. And if we put aside the Phase III data MANIFEST II and you look at the MANIFEST I data, so about stage, open label, and you put our data side by side, the SVR 35 at week 24, we think numerically we’re a little bit better. And if you look at the TSS 50, we think it looks clearly better at least numerically.
Obviously, there are side by side comparisons and we have to be careful. So based on that, we are cautiously optimistic that we can hit both endpoints, which is why we designed the trial and we’re going to go as fast as possible in this context. Now first line is different because the baseline of JAKAPFAI, as you know, is excellent. The combination data that we have, again, with the caveat that it’s open label, looks very, very impressive when it comes to symptom improvement and spleen reductions. But I think we need a little bit more data before making the decision whether to launch a first line trial.
Andy Behrens, Senior Biotech Analyst, Leerink: How important I mean, one of the differences you have, from from the other that inhibitor is your dose daily. You don’t have a drug holiday. We had talked to MorphoSys about this, and I know that they measure the symptom scores, I think, on an iPad every day, but they never disclosed, like, was there any change
Herve Urbapenow, InSite: over there? Twenty day. Right.
Andy Behrens, Senior Biotech Analyst, Leerink: I I mean those. Yeah. Yeah. We can
Herve Urbapenow, InSite: see that.
Pablo Canoni, InSite: I mean, we we agree with that principle as we discussed before that when people ask why do you think you’re better on symptoms, well, I’m not sure we are better. We’re numerically better in side by side comparisons. If we’re better, we turn out to be better. I think it’s because of what you mentioned, which is continuous dosing. I mean, look, it makes sense that if you stop a drug a week every third, you’re going to have and the half life is relatively short, you’re going to have some rebounding symptoms.
I mean, I haven’t seen any data as you as you pointed out, but it does make sense that dosing contingency will be helpful.
Andy Behrens, Senior Biotech Analyst, Leerink: Right. And I think they actually measured the measurement was taken during the drug holiday to to complicate it even further. Interesting. That that’s my belief. I don’t know the way We do.
Yeah. So okay. Well, and then in terms before we move on to some of the the pipeline and and Absolura, maybe the the CalR program, and some of the other efforts you’re you’re making to change the disease. You know, I I I guess it’d be good to to frame that in the context of of how much of the Jakafi population do you think that these drugs could eventually capture, and and what’s gonna be the role in the treatment paradigm?
Herve Urbapenow, InSite: What I can say is that there are two mutation in MF, PV, and ETs that are more than ninety five percent of all patients. And that’s six seventeen f and Gala. So basically, we are addressing both with two different strategies. One is an antibody for mutant CALA, the other one is a small molecule for 670F. If you dream that this both of them would be successful, it would not be replacing Jakafi in part, it would be exceeding by far the size of Jakafi today because it would be addressing all of the same patients we are speaking about in MF and PV and it would be adding the ET population, which is a fairly large population.
And the idea for both of these is to be disease modifying or more than that. I mean, it could be functional cure, if you think of what we have seen in the preclinical model. And that’s where that would be changing the entire treatment for patient with any of these three disease that are targeted by this mutation. So the way now it’s evolving is that we are more advanced with the color antibody. We are little behind with the 670F small molecule.
But during this year, in the next ten months that are left, we will be seeing data showing whether or not it does what we saw in the preclinical model, which obviously would be very meaningful in term of business opportunity.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. And what what would the development path I know you guys are probably still figuring out
Herve Urbapenow, InSite: with
Andy Behrens, Senior Biotech Analyst, Leerink: the FDA what, you know, how to get it approved, but what what do you think the the trial design would be?
Pablo Canoni, InSite: Look, there’s a couple of different ways to do this, and and the reason why I’m a little bit vague is because I think it’s gonna be better to have that conversation once we show data. But potentially they can be developed both a single agent and a combination, right? I think that if you think about MF and PV, the one thing Jacob, I meant Jacob, there’s many things very well, but one of them is rapid improvement in symptoms. Patients feel better very quickly. And so one could envision potentially an induction with JAKAFI in combination with a mutant cholera antibody, and then a long term sustaining and deepening of those remissions with the colore antibody.
And the reason why that’s really important for patients obviously and for us is you’re talking about a completely different duration of therapy. I mean, I just mentioned the average duration of in JAKAF is about two years in MF. And unfortunately, despite of the fact that JAKAF improved survival in patients with MF, everybody with MF eventually progresses and dies to the disease. We’re trying to change that. So not only we can expand the population, but you could talk about much longer duration of therapy with the mutant color antibody potentially, which we think obviously is going to be really good for patients and expands the market enormously.
So that’s one way to think about it. Rapid trial in JAKAFI failures with either mutant color antibody or with the six seventeen inhibitor. So once we have we start disclosing data over the course of the year, as I mentioned, we’ll talk a little bit more about the plans. But potentially, these medicines can be developed with single agent or combinations for Jakafi if we so choose.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. Do you think that the FDA might be, open to looking at the genetic information ctDNA showing suppression? Is there enough of a link between that surrogate and the clinical outcome of these patients? Or is that still kind of an evolving area?
Pablo Canoni, InSite: This will be a conversation we want to have, and the best way to have it is to have some of the data. We’re measuring allele burden in these patients. We think it’s important to show evidence of allele burden reduction over time in these patients because as part of a thesis, we’ve shown that in preclinical models and as part of a thesis how we’re developing these medicines. And, you know, once we have the data, we need to sit down with FDA and see if there’s a path forward. Obviously, we’re going to try to accelerate the approval of these new medicines because it’s critical for patients.
And if there is a way to do it by using a surrogate endpoint that has been done in other diseases by using basically a reduction of LDL burden reduction in the number of cells that carry the mutations basically, prior to having some longer term endpoints. If there’s a path to do it, we’re certainly going to explore it with FDA.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. Yeah. No. I mean, the the history of the company has been, you got Jakafi approved very quickly by creating an endpoint that
Pablo Canoni, InSite: We’ve entered the endpoint for Jakafi, so we’re gonna try to do that again. Yeah. We do that.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. Why don’t we shift
Herve Urbapenow, InSite: to The comparison is more, a little more, I mean, you can hear us that behind the words is what happened in CML when Vivek was introduced and the concept of molecular response became the endpoint that FDA accepted. It took years. It didn’t happen in a minute, but so there is this same vision of saying if we are showing that the burden is going down, then we are basically going to be working on validating that as a way to judge new products.
Andy Behrens, Senior Biotech Analyst, Leerink: Right. That was the analogy I was thinking of, the CML. So, why don’t we switch gears to Absolura? You’ve had the launched in several indications. You had some data recently reported in PN.
I guess, why don’t we talk about the commercial launch and then the data and the implications of that?
Herve Urbapenow, InSite: Okay. No, the launches are so now it was a few years ago when we started with atopic dermatitis in The U. S. And the beauty there was the speed of relief for each from eczema, which is unmatched. And frankly, I urge everybody to try it with their friends who suffer from eczema.
It’s literally extraordinary to the point where now we count it in minutes of time to each relief is very, very fast. And that’s something unique and that’s what patients are looking for, that’s what physicians are looking for, and that’s what’s going to help also in the pediatric indication where we know the itching, scratching, bleeding cycle is what really keeps eczema a big problem. So that launch has been going on for a while. It’s a key issue we that to continue to accelerate, which is what we are planning for is not only the new indication in pediatric AD, but it’s also simplifying the process for physicians, because physicians are notoriously not willing to spend hours on the phone on the prioritization process. So the big thing for us is how do we make it smoother for the physician to prescribe Obsedor for atopic derm and that’s part of our formulary positioning and we are making a lot of points.
So it’s a good it looks good. On top of it, we did and then we have Vitiligo. So Vitiligo is a completely different story. It’s a place where patients, most of them have been living with Vitiligo for a number of years, suffering without very good options to treat their disease. And we heard yesterday there are more people now sort of coming out to speaking about their Vitiligo.
It requires going back to see your dermatologist, which in many cases takes time. So the Vitiligo story is a story of building progressively a new franchise, a new indication where there was never any effective FDA approved product. And it’s happening as we see it. So access issues are less of an issues than in the big derm because it’s one prescription and then there is one year of treatment after that. It’s mostly patients going back to their physicians and physicians educating patients about how to use the product, how to continue to use it because it takes time to see the effect of the product.
So it’s almost the opposite situation than what we see in the topic dermatitis. Vitiligo is where we launched OBSELRI in Europe. That’s indication we used as a first indication and that was driven by reimbursement situation in Europe. And it ended up being very successful where we have seen a very good progress in Europe, where it’s now in Germany, Italy, Spain, France reimbursed and where it’s doing well. So the picture with OpCelloa in The U.
S. Is to continue the growth in both AD and Vitiligo, which is now like fifty five, forty five in terms of proportion of the two indication for the total volume of the brand, continue the launch in Europe with Vitiligo and get the new indications approved by FDA. And we can speak of the data we had at ADI. I must say, I just came here from Orlando at the Dermatology Congress. I mean, the level of noise and enthusiasm for OXYZARO is very high.
High. I mean, people speak about it. It’s one of the products that people are excited about. So it’s a good we are in a good place now.
Andy Behrens, Senior Biotech Analyst, Leerink: And the data in PN, you had one trial that was successful and the other had a high placebo response. You know, what why do you think that that occurred and, you know, what are the implications potentially?
Pablo Canoni, InSite: I wish I knew exactly what happened. Look, we presented so it was a late breaker as a TRUPN study one met the primary endpoint and all the secondary endpoints. What it showed is that in patients with prurigo nodularis, there’s a rapid and substantial improvement in itch as well as resolution of the lesions, which is with the IGA, the investigator global assessment tells you. So really important to show that a topical agent for the first time can show can freely provide important relief to patients with this terrible disease, which is, you know, persistent itch. The the age in scale is from zero to 10.
10 is the worst imaginable itch. The mean study entry was 8.5. So these patients have very, very severe itch. So that was really important. The second study, the primary endpoint, basically what happened is the highest as far as we can tell, the highest vehicle is different than placebo, but vehicle response in any major Phase III trials that we have been able to find.
So if you look at approvals for nimolizumab or Dupixent, this was a much higher rate of response in the vehicle arm. Our team has continued to I’m afraid I don’t have a definite answer for you today, but the important thing is that all the secondary endpoints trended strongly in the direction. Some of them, the nominal p values were, there. In others, there was a strong trend towards the fact that OBSELURRA indeed improves symptoms in this disease. So I think when you take the whole picture, what we know about, RUGS cream, about OBSOLURA in patients with atopic dermatitis, what we know from the phase two randomized data we showed in HS last year, and what we know from these two studies that this is an incredibly important topical medicine for patients with a range of dermatological conditions.
We’re gonna sit down with FDA. We’re gonna review the data on the PN studies, and we’re gonna try to find a path forward here so we can bring this to patients as quick as possible.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. And I I guess we’ll get an update when you have visibility on that.
Pablo Canoni, InSite: Okay. Well,
Andy Behrens, Senior Biotech Analyst, Leerink: I see unpredictability of drug development. A lot of factors. One of the probably the most promising assets that I get questions from is Povo. And you
Pablo Canoni, InSite: got a
Andy Behrens, Senior Biotech Analyst, Leerink: number a number of readouts coming. Yep. The first one is in HS. So why don’t we talk a little bit about that? I think there was some, people reading the tea leaves on some of your comments, Pablo, on the, the earnings call that you didn’t seem so confident maybe.
And, you know, how how confident are you in this readout? Because I think it is a very you know, even aside from the Jakafi, patent clip, I do feel like it’s one of the things that could could make people less concerned is that the revenue stream for the company because this this could be, at least in our assessment, a multibillion dollar opportunity. Yeah. It is important.
Pablo Canoni, InSite: You’re correct. So the first readout for povo this year is phase three two phase three studies the data in chronic spondensal as to what the placebo subtracted response is going to be. But we’re confident based on the randomized Phase II data that povercitoninib is going to be an important addition for patients with hyaluronidosuperativa. Once we have the results of the study, we’ll sit down and discuss in more detail. But at this point, I think we and we’ve said it repeatedly, we’re confident that we’re going to have, we’re going to have a path forward.
Andy Behrens, Senior Biotech Analyst, Leerink: Right. And I think, you know, looking at the the other agents, the injectable agents, there’s no topical available, no oral available. The range has been from low of Cosentyx in in the, I guess, the the low double digits to high of Humira. You guys showed around, what was it, seven 17%, I think. And I think your your comment was you have to replicate that.
But there was also, at twelve weeks, there was a 28% delta. Yep. So I guess the question is, which which part of it do you want to replicate, the 17 or the the 28?
Pablo Canoni, InSite: I I think what I said is, first, we need both studies to hit the significant p value that’s significant. That That needs to happen. We need two positive studies. It’s a new medicine. So that’s important.
And the second is, without speculating on numbers, yeah, we have to show that it’s subtracted efficacy here. What time point exactly and what, what number exactly is somewhere we’re not going to discuss at this point. But I think that what we’ve been consistently saying and we’re optimistic we will be there is that we’re gonna hit the p value to have two positive studies.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. And and from our diligence, there there really is that the doctors do want an oral option for these patients. And so I think that is a big proposition.
Herve Urbapenow, InSite: It should be useful, yes, it could be useful because you I mean, you know from experience in psoriasis, in a number of disease that there is a benefit of having an oral product when the rest of the competitors are injected.
Pablo Canoni, InSite: But let me just point one thing out. Obviously, the key is the primary endpoint when it comes to the regulatory interactions, but the whole package here is important. And when you look at the randomized Phase II data, it wasn’t just the data week 12 and week 16 and not just high score 50. When you look at patients in povo, particularly over time, the deepening of the responses, the maintenance of the responses, there are almost thirty percent of patients with high score 100 and the rapid sustained improvement in pain, which may not be a primary endpoint, but it’s something the patients obviously that that is important for them. The whole package is what I think we need to look at once we see the data.
Speed as well as a deepening of the responses and it’s not just the highest scores, but the improvement in pain.
Andy Behrens, Senior Biotech Analyst, Leerink: Right. Okay. And you did take some you did make some changes to the the trial design to lessen the placebo response. Right? You you moved it to twelve weeks and then you also had more severe patients.
Pablo Canoni, InSite: We have a little bit more high, Harley three patients just to reduce the placebo effect. The percentage of patients with prior biologics is consistent, maybe a little bit higher, about thirty five percent, forty percent. So we think it’s going to be a representative population. And at the same time, we think there are chances of a placebo effect should be lessened a little bit.
Andy Behrens, Senior Biotech Analyst, Leerink: K. And those data are coming soon.
Pablo Canoni, InSite: Data are coming before the end of the half.
Herve Urbapenow, InSite: Yeah. First half. Yeah.
Andy Behrens, Senior Biotech Analyst, Leerink: Alright. In terms of the the rest of the pipeline, I mean, I know the
Herve Urbapenow, InSite: the Just on provol, I mean, the HS is the first indication. I mean, there is an entire program on provol. It’s a very special drug. I mean, it’s a very special JAK inhibitor. It’s way more selective than the existing one.
It has a long half life. It has a very large volume of distribution. So it’s a product that we believe has application beyond HS. We have studies in Vitiligo. We have studies we are doing in the ProEgo Nodularies.
And now and we have pre book studies we are doing in CSU and asthma. So the way we see it is just HS is the first to consume, but there is a real growth opportunity for Provo across number of indications.
Andy Behrens, Senior Biotech Analyst, Leerink: Right. And I guess asthma is obviously one of the largest ones, but also probably the riskiest just in
Herve Urbapenow, InSite: Yes. It’s a phase two. I mean, we are in the phase two setting for CSU and asthma and phase three for the other three indications.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. And the rest of the pipeline, I know you highlighted a number at the JPMorgan conference, which the last minute left, which of the other programs would you like to highlight? CDK?
Pablo Canoni, InSite: Look, the most advanced is our CDK2 inhibitor. I think we can be first there in ovarian cancer. We presented data at ESMA last year. We’ve shown clear events of single agent activity with a very, you know, tolerable safety profile. Obviously, you expect some heme toxicity, but the number of patients with discontinuations and dose reductions was pretty low, was less than ten percent.
So we think that that speaks well to biliary to our CDK2 two inhibitor to be administered for long periods of time, which we think it’s important as we since we’re going to start with platinum resistant ovarian cancer, that’s going to be the first pivotal trials we’re launching, then to move to early lines of therapy in platinum sensitive patients. So post chemotherapy in combination with brevacizumab, platinum sensitive ovarian cancer that is really long duration of therapy. You need a convenient and well tolerated medicine to do that, and we think we have that in our CDK2 inhibitors. So that’s the key driver this year is to get the pivotal trials in ovarian cancer started because we are ahead of our competition and we want to stay that way. We’re generating data in endometrial cancer and we’re combining with a number of medicines in breast cancer to try to understand what the path forward is there for us.
And then the rest of the pipeline, I know we’re out of time, but you know, we like our KRAS G12D inhibitor. We understand it’s a very competitive space, but we think that there’s still room for improvement, particularly in combinations. And we’ll have data at some point this year. And we continue to be encouraged by our TGF beta receptor two by PD-one as well. So I think there’s going to be a lot of readouts this year as we as survey mentioned at the beginning of the presentation, and we look
Andy Behrens, Senior Biotech Analyst, Leerink: forward to updating you. When will be the next
Pablo Canoni, InSite: update for the CDK2? We haven’t decided. At some point this year, we’re going to provide a data update and an update on the regulatory path. We haven’t decided exactly when that’s going to be. I think some of the options are obvious over the course of the year, but we haven’t made that decision yet.
Andy Behrens, Senior Biotech Analyst, Leerink: Okay. Okay. Thank you, Pablo. Thank you, Herve.
Herve Urbapenow, InSite: Thank you very much.
Andy Behrens, Senior Biotech Analyst, Leerink: Congrats on all
Pablo Canoni, InSite: the progress.
Andy Behrens, Senior Biotech Analyst, Leerink: Thanks for joining us. Thank you, everyone.
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