Hello, and welcome to Genmab's investor event. We ask that you please hold all questions until the end of the prepared remarks, at which time covering analysts will be given instructions for the question and answer session. As a reminder, this conference is being recorded today. If you have any objections, please disconnect at this time. I would now like to pass the call to Jan van de Winkel, Genmab's CEO. Please proceed.
Hello, everyone, and welcome to our investor event. I can tell you this has been a really exciting month for Genmab and more importantly, for patients. We delivered three positive phase III clinical readouts in three different cancers, diffuse large B-cell lymphoma, platinum-resistant ovarian cancer, and head and neck cancer. At ESMO, new data that support taking petosemtamab further into colorectal cancer. There are three things I want you to take away today. First, we believe the three phase III readouts have the potential to change how patients are treated. Second, data at ESMO on petosemtamab support expansion into colorectal cancer. Third, what this means for Genmab, multiple potential launches starting in 2027 and a growth trajectory increasingly driven by our own medicines. So with me today is our Chief Medical Officer, Tahi Ahmadi, who will walk you through the data.
For our Q&A, we will be joined by our Chief Financial Officer, Anthony Pagano, and our Chief Commercial Officer, Brad Bailey. Next slide. As always, we will be making forward-looking statements, so please keep that in mind during the call. Actual results may differ materially, and please refer to the statement on this slide and to our filings. As we are in a quiet period, today's discussion is limited to information already in the public domain. We will cover the broader business on our Q3 call on November the 5th. Next slide. At JP Morgan in January, I said 2026 would be a defining year for Genmab. We have been clear about what we set out to do. We told you that EPKINLY, Rina-S, and petosemtamab were on track to phase III readouts in the second half of this year, setting up potential approvals and launches in 2027.
That is exactly what we have done. In one unprecedented month for Genmab, we've reported three phase III data sets that each have the potential to establish a new standard in their respective indications. EPKINLY for R-CHOP, plus R-CHOP in first-line diffuse large B-cell lymphoma, reducing the risk of progression or death by 51%. Rina-S in platinum-resistant ovarian cancer demonstrated a 71% reduction in the risk of disease progression, and a 57% reduction in the risk of death in the ITT population. Petosemtamab plus pembrolizumab in first-line head and neck cancer showed both a statistically significant improvement in response rate and in overall survival. Each is in a setting where patients need better options, and each has the potential to change the standard of care. The phase II data at ESMO show that petosemtamab can go further into colorectal cancer. Next slide.
This slide shows how we got there. Over the past 10 months, we had three phase III readouts for EPKINLY in January, June, and October, both phase II and phase III data for Rina-S, and the first phase III readout for petosemtamab, each on the timeline we guided. There is more to come with the phase III LiGeR-HN2 readout in previously treated head and neck cancer expected in the first quarter of 2027. Together, these data support potential approvals and launches beginning in 2027. This is what we have been building towards. It reflects our focused execution and the strategic choices we made with Rina-S and petosemtamab. In January, I told you that we deliver on our promises. This month, we have shown it.
What sets Genmab apart is not just our great science, but our consistent ability to execute with speed, agility and a focus on patients. Tahi, the floor is yours now.
We can go to the next slide. Thank you, Jan. Let me start with EPKINLY in first-line diffuse large B-cell lymphoma, the largest opportunity in B-cell lymphoma and in a setting where R-CHOP has been the gold standard for more than a decade, and where way too many patients still relapse after frontline therapy. If you can go to the next slide. EPCORE DLBCL-2 is the first phase III trial to show that adding a bispecific antibody to frontline chemoimmunotherapy significantly improves progression-free survival in diffuse large B-cell lymphoma. In patients with an IPI score of 2- 5, EPKINLY plus R-CHOP reduced the risk of progression or death by 51%, a hazard ratio of 0.49, with a P value below 0.0001. To put that into context, the landmark trial that established R-CHOP as a standard of care was almost 25 years ago.
In a disease where a segment of patients is cured, the addition of rituximab to R-CHOP, with a hazard ratio of around 0.58 back then, was considered to be the ceiling of what one could reasonably expect. Cross-trial comparisons always have their limits, but even with the most recent positive phase III trials, a hazard ratio of 0.49 speaks for itself. It did so with a fixed duration subcutaneous regimen, and with the safety consistent with the known profiles of epcoritamab and R-CHOP. This is a pattern we've now seen multiple times with EPKINLY. Efficacy and safety are very predictable. The phase II combination data are highly consistent with the larger phase III data sets. We saw that in the combination with daratumumab in June, and we see it here again.
In our view, these results have the potential to change frontline practice in diffuse large B-cell lymphoma. We look very much forward to presenting the full data at a future medical meeting. Together with AbbVie, we will engage with the global health authorities. Next slide, please. Here is why this matters. Today, EPKINLY's approved indications, third-line plus diffuse large B-cell and follicular lymphoma, and more recently, second-line plus follicular lymphoma, address around 27,000 patients. With potential 2027 launches in second-line plus and first-line diffuse large B-cell lymphoma, and first-line follicular lymphoma to follow soon, EPKINLY can address around 146,000 patients across the U.S., EU5, and Japan, more than five times where we are today. First-line diffuse large B-cell alone represents around 70,000 of these patients, by far the largest population, where we can have the greatest impact for these patients. We have prepared for this moment.
Frontline patients are primarily treated close to home, in their community. Our work to date with EPKINLY has built strong momentum among community sites, with broadening treatment experience across both diffuse large B-cell lymphoma and follicular lymphoma. This will be important as we look ahead to a potential launch in frontline diffuse large B-cell lymphoma. In fact, we shared during our last earnings call that the majority of new adoption for EPKINLY in the U.S. came from community centers, exactly where these first-line patients are treated. If we can go to the next slide, please. The phase III readouts this year put EPKINLY on a path to span diffuse large B-cell and follicular lymphoma from first line onwards, with data in first-line follicular lymphoma still to come in the future.
With a differentiated dual indication profile and demonstrated versatility across lines of therapy and histologies as a monotherapy or in the various combinations, EPKINLY has the potential to become the core therapy in B-cell malignancies. We see a peak sale opportunity of more than $3 billion for this program. With the frontline data in hand, we believe we are around 1-1.5 years ahead of the main competitors in this setting. Let us turn to Rina-S. Next slide, please. Rina-S is the first of our two wholly owned late-stage medicines we will talk about today. We have two data sets to cover here, the positive phase III RAINFOL-02 top line, and the phase II RAINFOL-01 data presented at IGCS. Next slide, please. The phase II data at IGCS show why we had such high conviction going into the phase III readout.
In heavily pretreated patients, Rina-S delivered a confirmed response rate of 45.9% and a median duration of response of 12.1 months. These responses were seen across the folate receptor alpha expression levels. The safety profile supports long-term use. There are no ocular events, no neuropathy, and no ILD signal. Only 1.8% of patients discontinued due to treatment-related adverse events, as I said on our call in the second quarter in August. Put these together, and you could already get a sense of the direction of the PFS and what RAINFOL-02 has now shown. Next slide, please. RAINFOL-02 marks a significant milestone for Genmab and for women with platinum-resistant ovarian cancer, who today have limited treatment options. The study met its primary endpoint of progression-free survival versus investigator choices therapy in both populations we analyzed.
In the intent-to-treat population, which comprised all randomized patients with PROC, regardless of their folate receptor alpha expression, Rina-S demonstrated a 71% reduction in the risk of progression or death with an unprecedented hazard ratio of 0.29. In the primary analysis, which mandated that patients with a folate receptor alpha expression above 75% PS2 positivity had to be treated with mirvetuximab, Rina-S demonstrated a 67% reduction in the risk of progression or death with a hazard ratio of 0.33. Importantly, RAINFOL-02 also met its key secondary endpoint of overall survival in both populations. Safety was consistent with what we have seen before, with no new safety signal. These results support the phenomenon we have routinely described with Rina-S, that is the efficacy irrespective of folate receptor alpha expression level or prior treatment with mirvetuximab.
This gives Rina-S the potential to reach a much broader group of patients. Our ambition for Rina-S has been from the beginning to be the best, first, and broadest in class, and we plan to file as soon as possible with the potential launch in 2027. We will present the full data at a future medical meeting. Let me now go to the next slide, please. When we acquired ProfoundBio in May 2024, there was one phase I/II trial ongoing. Today, there are six phase III trials that have been announced, initiated across ovarian and endometrial cancers, addressing around 79,000 patients. PROC is the first potential launch. With possibility of endometrial and platinum-sensitive disease in the future, we are building a franchise we own entirely, with a peak sales opportunity of more than $2 billion.
With the phase III data now in our hands, Rina-S has the potential to become best-in-class ADC. Combined with our established global presence in recurrent or metastatic cervical cancer, the breadth of our programs in ovarian and endometrial cancer positions us well to lead innovation in the gynecological cancer space. Next slide. Now finally, let's move on to petosemtamab, our second wholly-owned late-stage medicine that we believe has the potential to redefine how epithelial cancers are treated. I'll offer three updates here, the phase III LiGeR-HN1 top line in first-line head and neck cancer, and the updated phase II data at ESMO in both head and neck and in colorectal data. If we go to the next slide, please. In August, we said ESMO would show why we are so enthusiastic about petosemtamab. First, let's focus on head and neck cancer.
In first-line head and neck, the phase II data that underpinned LiGeR-HN1 have held up with the longer follow-up, a 63% confirmed response rate, and a median overall survival of 28.2 months. This data is support of the phase III data we announced just this morning, as you will see on the next slide. LiGeR-HN1 enrolled around 700 patients with first-line PD-L1 positive recurrent or metastatic head and neck cancer, comparing petosemtamab plus pembrolizumab with pembrolizumab alone with a dual primary endpoint of response rate and overall survival. At the first interim analysis conducted by an independent data monitoring committee, the combination delivered a statistically significant and clinically meaningful improvement in response rate regardless of HPV status. It also significantly improved overall survival, reducing the risk of death by 50%, meeting both primary endpoints. Petosemtamab was generally well-tolerated with no new safety signals. Let me put this into context.
Today, patients with first-line head and neck cancer face some of the most dismal outcomes of any front-line cancer. Pembrolizumab alone delivers response rate in the high teens to low 20s, and an overall survival of roughly a year. When you combine pembrolizumab with chemo, the results aren't much better. The overall response rate increases to approximately 36%, with a modest improvement in overall survival to 13 months. Going back to what I said, that if the phase III came anywhere in the ballpark of our phase II data, there would be no question this would be the new standard. This makes petosemtamab the first bispecific antibody with positive phase III data in first-line head and neck cancer, the largest population in this disease, and in a setting where currently pembrolizumab alone or in combination with chemo is the standard of care.
We believe this has the potential to change that standard, bringing us closer to potentially delivering the first EGFR-targeting bispecific antibody approved for first-line head and neck cancer. This enforces our conviction that petosemtamab is not only potentially the first, but also the best-in-class second generation bispecific as an EGFR LGR5 bispecific antibody. We will present the full data at a future meeting, and engage with regulatory authorities on a potential filing here as well. Next slide. Also at ESMO, we presented updated data in colorectal cancer. Colorectal cancer gives petosemtamab a second path for growth beyond head and neck cancer. Here, petosemtamab plus chemotherapy delivered response rates of 81% in left-sided first-line tumors, and 67% in second-line disease control in both above 90% with no new safety signals.
These data support the two phase III trials in colorectal, addressing a patient population around three times the size of head and neck. We go to the next slide. When we acquired Merus N.V., we said we would pursue a broad focus development. Today, we have a positive phase III in first-line head and neck, LiGeR-HN2, will read out in Q1 2027, and two phase III trials in colorectal cancer, a program addressing already around 315,000 patients with multi-billion-dollar peak sale potential. To sum it all up, three phase III trials, three positive results in three cancers where patients need better options, and in each case, the phase III results are consistent with the phase II data that led us here. With that, I'll give it back to you, Jan.
Thank you, Tahi. Very clear. Let me bring it all together. Next slide, please. Over the past decade, we have taken Genmab from a royalty-based company to a fully integrated biotech with its own medicines and a powerful late-stage pipeline. This month is the proof point for that strategy. What does this all mean for Genmab? To me, it comes down to three things. First, three positive phase III readouts in first-line DLBCL, platinum-resistant ovarian cancer, and first-line head and neck cancer, each with the potential to change clinical practice. Second, new data at ESMO on petosemtamab that support expansion beyond head and neck into colorectal cancer. Third, a development plan and clinical evidence that combined supports a growth trajectory you can now see very clearly.
Multiple potential launches beginning in 2027, with peak sales potential of more than $3 billion for EPKINLY, more than $2 billion for Rina-S, and multi-billion dollars for petosemtamab. Two of these three medicines are wholly owned. Together, these three programs carry five FDA breakthrough therapy designations, and with six new phase III trials announced this year, each one is still expanding. In August at our Q2 call, I said that with three super important phase III studies reading out, we are well on track to deliver sustainable growth well into the next decade. Together today, with three positive results in hand, I can say with great confidence that growth will increasingly be driven by our own medicines. None of this would be possible without the patients and caregivers who take part in our trials, the investigators, and our talented and passionate colleagues across Genmab. Thank you.
Our purpose is to transform lives with pioneering antibody science, and this month brought us closer to doing that for many more cancer patients. Next slide. That now ends our formal presentation. Operator, please open the call for questions, and thank you.
Thank you. At this time, if you would like to ask a question, please click on the Raise Hand button, which can be found on the black bar at the bottom of your screen. When it is your turn, you will receive a message on your screen, and then you will hear your name called. Please accept, unmute your audio, and ask your question. If you are calling in today, star nine will activate the raise hand feature, and star six can be used to mute and unmute your line. We ask that you please limit yourself to one question this morning. We will wait one moment to allow the queue to form. Our first question will come from the line of Yaron Werber with TD Cowen. Please unmute and ask your question.
Terrific. Congrats on the really landmark results. Really great to see this. I guess the big question is, it looks like this data is relatively immature for the HPV positive population. Would you agree with that, and should we assume that roughly 20% of patients were HPV positive, in which case most of the effect must have been driven, a lot of it, by the HPV negative population? Thank you.
Thanks, Yaron, for the question. I will hand it over to Tahi to give potentially more color there. Tahi?
Thank you, Yaron, for the question. The first thing I would say this, the study population, broadly speaking, and that is not only true for HPV positive, but for local region versus metastatic and for the various subtypes of head and neck, is almost on point reflective of the epidemiology of the disease. That is the first point. The second point is, I am not sure where this idea comes from that there is a difference between the subgroups in terms of maturity. The data met its statistical significance because the hazard ratio is so profound. That is just the way statistics work. Obviously, there is a follow-up, but the way it tells you a little bit what the scale of the OS difference was with that follow-up.
Just to basically get to the point, broadly speaking, regardless of HPV positive or negativity or any of the subgroups, I think it is fair to say that all subgroups in one way or the other had a positive outcome on this trial and benefited from the combination.
Thanks, Tahi. I think we should leave it with this, Yaron, and then we will give further color at the medical conference, hopefully soon. Let us move to the next question, operator.
Your next question will come from the line of Xian Deng with UBS. Please unmute and ask your question.
Hey, thank you so much. Really congratulations for your really extraordinary data, all of them. So maybe if I could ask a maybe bigger picture question, please. Just looking at your peak sales guidance, you still kept your $3 billion for EPKINLY, $2 billion for Rina-S, even including front-line endometrial, right? Now you have your own phase III data, and you've probably also seen the latest updates from the ESMO from your competitors. Just wondering, I would think your peak sales guidance are probably vastly below what the street is actually expecting now. I'm just wondering how do you think about this guidance and any colors on the thoughts behind, please. Thank you.
Thanks, Xian, for the compliments, and I hand this question over to Anthony, who can give you a bit further color on our thinking on peak sales guidance. Anthony?
Yeah. Thanks, Xian. Look, I think as a starting point, and you all know this, we had high conviction around our three very strong products. Of course, that's EPKINLY, Rina-S, and petosemtamab. And now what you've seen here during the month of October is that we've backed up that high conviction with these very strong phase III data sets across all three products, and Tahi has done a wonderful job really elucidating that point. And then that takes us to the next point, and that gives us high conviction in the peak year sales estimates that we've previously communicated, again, across EPKINLY, Rina-S, and petosemtamab. And I think here's an important point, and we stand fully behind those estimate.
This conviction not only comes from that strong data that we presented, but it also comes from the very strong capabilities that we have intentionally built out here at Genmab over the last number of years. That is the capabilities to develop these products. It is also the very strong commercialization capabilities and the strong performance we have seen for TIVDAK and EPKINLY. Of course, in addition to that, all of the pre-launch work that we have done across all three brands here, moving forward. Xian, what I am going to leave you with is that we stand fully behind the estimates that we have previously provided and are super excited about the data we have been able to present here and deliver to the market during the course of October.
Thanks, Anthony. Thanks, Xian, for the question. Let us move on to the next one, operator.
Your next question. Next question will come from Michael Schmidt with Guggenheim. Please unmute your line and ask your question.
Hey, guys. Congrats on this amazing execution on these phase III studies and also very smart business development. Any comments on how the pembrolizumab control arm performed in the head and neck cancer study relative to historic studies? Just curious. As you have this very impressive data now in hand that clearly de-risks petosemtamab as a product candidate, how do you think about expanding that opportunity into other cancer types? I did see you had the collaboration announcement with Incyte recently, obviously on the KRAS inhibitor, but I am curious if there are other opportunities that you could now evaluate with this validation in hand. Thanks so much.
Michael, thanks very much for the compliments. Then I hand this over again to Tahi. Control arm, Tahi, then the expansion plan for petosemtamab, because we are super excited, as you can imagine, Michael, about what you're seeing here. Tahi?
Yeah. Look, without getting into a nuanced discussion on the data of the trial, which I think you will appreciate will probably more appropriately happen in the context of a medical conference, I think it's probably fair to say that the pembro arm behaved exactly the way a pembro arm has behaved in the past. On future plans, I think we have been very clear in our ambition, I think from the day when we announced our intent to acquire Merus N.V., that we're going to anchor petosemtamab in head and neck, and really think of it as the best in class bispecific, EGFR bispecific in the entire space. Now recently also have put a little bit more emphasis on the very exciting opportunity in colorectal cancer.
As it goes through the concrete studies that we're going to initiate, I think we're going to stick to what we've been practicing now for, I think, the last 12 months or so, where we are going to be very disciplined in announcing new trials right around the time when they are actually open. I keep saying this, it's a very competitive field. Everybody's watching. But if you followed how this has translated for Rina-S, I hope you have the trust in us that we are going to expand this program appropriately with all the conviction that we have in petosemtamab as a drug to bring this innovation, which we really think is a transformative innovation, to as many patients with head and neck as possible.
Thanks, Tahi. Michael, it comes down to execution from here, I think on multiple fronts, both in the clinical trials as well as in the filing and bringing it to the market for Rina-S and for petosemtamab. We're very focused on execution in the coming time.
Next up will be James Gordon with Barclays. Please unmute your line and ask your question.
Hello, James Gordon from Barclays. Thanks for taking the question. My question's on regulatory and commercial. So planned timelines for global filings, not just the U.S., but Europe, Japan, and China. Can you get all three of these done, say, in the next six months, or are there any further things needed? Do you need more mature data in other places? And the commercial part of that, does it now make sense for Genmab to build a truly global sales force in, say, head and neck and GYN onc, or could we actually see some partnering announcements in some regions, particularly outside the West? Is there a reason a larger company couldn't make even more of these products or help you make even more of these products, which look like they're very strong clinical data?
Thanks, James, for the questions. I will ask Tahi on the first one, the regulatory process in the different territories, and then Brad can comment on the expansive commercialization plans we are putting into gear at this moment. Maybe, Tahi, you can start on the sequence of the regulatory filings and the timing, roughly.
Sure, James, and unfortunately, I won't do that. I will just say that with the profound OS benefits, I think it's very clear that we will engage globally with all the relevant health authorities in the most expeditious time possible.
Thanks, Tahi. Brad, a bit of color on the commercialization.
Yeah, thanks for the question. As we know, oncology is an extremely competitive and data-driven market, and this data gives us extreme confidence. As you've mentioned, as we've said all along, we've built our capabilities from a commercialization perspective with this level of growth and portfolio expansion in mind. The differentiated focus that we've currently brought, both U.S., Japan, and now in Europe, around scientific engagement, customer engagement, as well as our market access and patient support services, really puts us in a position to be extremely confident to execute moving forward. We can certainly update more as we move along the progress here.
Thanks. Thanks, Brad. Thanks, James, for the questions.
Your next question will come from the line of Benjamin Jackson with Jefferies. Please unmute and ask your question.
Thank you for the question. Just two quick ones from my side. The first is on Rina-S. I think it's becoming clear in the PROC space that a big driver of the efficacy or the clinical efficacy that we're seeing is actually the duration of response. Are you able to comment or give any color in and around how duration of response varies between the folate receptor alpha different subgroups, given that could be a better predictor of the actual clinical efficacy we're seeing between those groups? Secondly, just interested to hear your thoughts going forwards in and around epcoritamab combinations and at the earlier line blood cancer, so specifically around DLBCL. You've obviously shown previously from early-stage data in and around the combination with Polivy. Is this something that you could pursue, and how would you pursue that?
Do they need full-blown phase III randomized controlled trials, or could you do it in a simpler and quicker fashion to enhance the label earlier? Thank you.
Thanks, Ben, for the questions. I think they both go to Tahi, first on the Rina-S PROC and duration of response. Then epcoritamab. We think that epcoritamab is very, very good for combinations and the different other medicines, as we already have shown now with several combination partners. Maybe Tahi can give a bit of color on that as well on the plans for epcoritamab together with Polivy. Tahi, why don't you start with Rina-S?
Sure. Thank you for the question. Let's start in the beginning. I think we said this for a while, and you touched on this, that one of the many differentiating aspects about Rina-S is its safety profile, its tolerability, its lack of neurotoxicity, of eye toxicity, or for that matter, of interstitial lung disease. This tolerability with a very, very low rate of discontinuation due to AEs, mainly related to neutropenia, that's really almost restricted to the first cycle, is leading to long duration of treatment, and that is beyond the overall response that's driving the duration of response.
Now, I'm not going to get into a discussion on how these different subgroups behave specifically because I think you will appreciate, like to the answer I gave to the petosemtamab question, that this is probably best done in the context of a full disclosure of the data and the whole demographics and all of this. But I would say with a hazard ratio of 0.29 on a PFS, it's really not that hard to imagine that essentially, whichever way you were going to look at the data, slice the data, there was an unprecedented benefit for patients. On the EPKINLY question frontline, you're right. We also generated data with Pola-R-CHP in combination with EPKINLY and have an opportunity to present that in the future, and then we'll have a conversation about that.
Look, given the fact that we have such a profound positive trial with R-CHOP, I think our focus is on R-CHOP. Globally, it is still, for the totality of patients, the standard of care. Pola-R-CHP has made some inroads, I think predominantly for patients with ABC, if you really look into it. Now with a completely new standard of care, the way we think, I think a lot of this is going to fall into the hands of EPKINLY, R-CHOP, which really honestly, with the unprecedented hazard ratio for the few such patients, beyond, I think what reasonably could have been expected before the emergence of bispecifics. I think that's where the focus is. This data is, of course, important.
That's why we're generating it, and we will continue to engage with the respective ways of engaging with health authorities or other methods of making this combination also available for patients. But I don't foresee us having another phase III of that scale and size. That's probably not the best resource spent for us. The focus is on the transformative data that we have generated and the significant time advantage that we have over what.
Thank you, Tahi, and thanks-
Thank you.
for your question, Ben.
Your next question will come from the line of Victor Floc'h with BNP Paribas. Please unmute your line and ask your question.
Hi. Thanks a lot for taking my question. First, massive congrats on all this fantastic data. Incredible job across the board. Maybe first question on petosemtamab. I have to try my luck here. Any chance you could share a bit more on how consistent the OS benefit was across the different PD-L1 CPS groups?
And do you believe petosemtamab could become a new standard of care across the entire PD-L1-positive population? A quick follow-up on locally advanced anal cancer. To what extent do you think these results have furthered the risk dupatitib[inaudible] in that setting? Does the magnitude of the survival benefit give you greater confidence in moving into earlier stage of the disease? Thank you very much and congrats.
Thanks, Victor. Both questions go to Tahi again. Tahi, why don't you kick it off?
Yeah. Thank you for the question. I will answer it the same way that I answered the earlier question, which is, whichever you slice and dice it, patients benefited on the LiGeR-HN2 trial, and that's in response in OS. I think that probably should suffice for today in terms of detailed subgroup discussions. Of course, you are absolutely 100% right. If you have such a profound impact on overall survival and also on response, that has an impact on how you view the probability of success of the local regional setting, particularly when you know that roughly a third of the patients who were enrolled in the trial, their first emergence of the disease was actually local regional. So I think there's a lot of readouts that are important and that have an impact on how we think about the local regional space.
So more to come on that end.
Thanks, Tahi. Thanks, Victor, for the questions.
Thank you.
Your next question will come from the line of Gregory Renza with Truist Securities. Please unmute your line and ask your question. Since you are on the phone, please hit star six to unmute your line.
That is great. Thank you, and congratulations Genmab team for the monumental data points today and over this last stretch. Jan, maybe just a question for you, and maybe allow me to ask you to reflect a little bit on really what the significance is of these three late-stage programs hitting over the course of the month. Could you just add some color on what that means for you as you have reflected over your career on something as significant as this? You certainly mentioned execution as maybe one of the secret ingredients. As you think back to the ProfoundBio acquisition and of course, more recently, Merus N.V., maybe just touch on what you were seeing there that certainly pulled through to the success today and how that carries forward. Thanks so much and congrats again.
Thanks, Gregory, for the compliments. I would be happy to speculate here and give you a bit of color. I can talk the whole hour, I think, on this, but let me condense that. What we are, I think, very good at as a company is understanding a bit of diseases. We can completely understand and actually target well for antibody-based medicines. Also, we are very focused on the mechanism of action of these molecules, so I think we have a better understanding of how these actually work, these antibody-based medicines, than other companies. So that makes us a very good candidate, I think, to also look outside for innovation, what we have done twice now, once with ProfoundBio in May 2024 and once in December last year, only very recently with Merus N.V..
Because we actually could understand the mechanism of action of these antibody-based medicines better, I think, than other parties. In that way, we could focus very much on execution and actually very rapidly move them to the clinic and very rapidly expand them. Then actually, basically in settings that we could understand, and actually then very effectively move to phase III data. That is what all culminated in the last three weeks, Gregory, that basically one organically created molecule, epcoritamab, and two inorganic molecules were hitting actually truly unprecedented data in different clinical settings. But that comes very much down to the experience we built up in the company over the last 27 years. So that gives me a very good feeling. Today is definitely a day, Gregory, I will never forget, I can tell you.
This is quite amazing data. I saw the emotions on one of the oncologists who was presenting the data just before you saw them today to our portfolio board, which I chair in Genmab. The profound emotion I saw on my colleague's face when she described the detailed data, you have only seen the headline data from petosemtamab in head and neck cancer front line, made it completely clear to me that we are actually doing something really, really good for patients and their families in the coming years. That is in the end what drives me and all the team members at Genmab to actually make this world a better world by providing better treatments for cancer patients. This is all coming together now in a very short timeframe.
From here on, it is bringing the antibodies to the market and then helping more patients as soon as we can get there. I think I should leave it with that, Gregory, for now.
Your next question will come from the line of Qize Ding with Rothschild & Co Redburn. Please unmute your line and ask your question.
Thanks for taking my question. Qize Ding from Rothschild & Co Redburn. Congrats on the success across the board. I just have one quick question for Anthony. Given now you have plans for new clinical studies, how should we really think about,
You haven't provided any guidance on OpEx, right? But how should we really think about the R&D expenses? Also, you talk about the potential commercial launch, so how should we think about SG&A expenses next year? Any color would be great. Thanks.
Yeah, thanks for the question. Just want to remind everybody on the call that we are in a quiet period. We do have our Q3 earnings call on November 5th. What I can sort of offer for you though, to let you provide some more color about how we think about this, it's going back to what we've said. We've been very clear, both from an operational and business perspective, but also a financial perspective, what our commitments are. We've told you what we're going to do, and we've done it. Now we've just delivered here on very, really just tremendous phase III data across all three brands. We've delivered on these commitments in terms of backing up that high conviction around these three assets. Likewise, together with the rest of the management team, we've been very clear with the capital markets what our financial commitments are.
We've told you on the other side of the Merus acquisition that despite the significant investments in petosemtamab and Rina-S, we would drive significant EBIT in 2026. We've told you we'd be very focused and disciplined in our investments, and we've talked a little bit about the forward trajectory. What I would say for now is look at all of the commitments that we've made, also from a financial perspective, and we'll continue to operate our business with that same focus and discipline from an operational perspective as well as a financial perspective. It'll be that same thought process and mentality moving forward. That's probably where I'll need to leave it for now, just recognizing that we are in a quiet period.
Thanks, Anthony. Thanks, Qize, for the question. Let's move on to the next
Sorry, go ahead.
No, that's okay. Next question will come from the line of Nicole Berritto with Wolfe Research. Please unmute and ask your question.
[inaudible] . Congrats on the recent data. You mentioned that the addressable patient population for Rina-S across various indication, but we were wondering about the 1L ovarian cancer maintenance trial and how that could expand the total addressable market for Rina-S, as well as the timelines for this study. Then we also wanted to ask about how you view Gilead's NaPi2b drug and the competitive landscape for PROC. Any comments on pluses or minuses versus Rina-S on cross-trial comparisons? Thank you so much.
Thanks, Nicole, for the questions. Tahi, can you take these two?
Yeah, so I have to say, I understood the question about PROC, but there was a question before that was breaking out of my line a little bit. If you want to just repeat that first part of your question. Oh, NaPi2b, that's what it was?
Yeah.
Okay. So broadly speaking, the same question. All right. Let me do this this way. Look, when we acquired ProfoundBio, we were very clear. We thought, A, folate receptor alpha was the best target in the GYN onc space. B, that Rina-S was the best folate receptor alpha ADC. We made that point back then based on the specificity of cetuximab, and the linker, and the hydrophilicity of the linker, and the totality of the antibody construct, and how that was differentiated from some of the other TOPO1 ADCs, and why that on the safety side will matter, and while we believe that we would have results across the entire spectrum. So here we are now, the first phase III to read out in the PROC space, Rina-S, with these unprecedented results.
And you have some visibility to the profile of the drug, of course, through the phase II data that was also presented at IGCS, with the most phase III of any TOPO1 right now, active or in the setup of enrolling patients across GYN onc and endometrial. I think broadly speaking, we feel very strongly that Rina-S is on its path to being the best-in-class ADC regardless of target, because it has the efficacy regardless of folate receptor alpha expression. Broadly speaking, that means any woman with ovarian cancer. And because of its safety profile, which just to repeat myself, that leads to this long durability and duration of response. It is a first in class, and it is also on its way to become the broadest in class. I think that is how we see this and everything else is everything else.
Thanks, Tahi. Then again, Nicole, it comes down to execution. Do these trials effectively and rapidly, and then try to be ahead of the competition. Because that is important in the future because of these class effect of these TOPO1, as summarized, inhibitor-based ADCs. I think it is important to be first on the markets.
Let us move to the next question.
Next question will come from the line of Matthew Phipps with William Blair. Please unmute your line and ask the question.
Hey, let me offer my congrats on truly transformational data. Another competitive question. Obviously, as when we saw the sac-TMT TroFuse-005 study in endometrial, looked like the benefit there was mainly driven in the moderate to high TROP2-expressing patients. How do you maybe see that landscape playing out where you won't be first to market? Do you think there will be maybe subgrouping based on expression levels? Thank you.
Thanks, Matthew. Tahi, can you handle this one?
Yes, sure. You said it, so I will repeat it, because I don't usually like necessary to talk about other companies' drugs. First of all, congratulations. This is an impressive phase III result for these patients with endometrial cancer in the second line. But as you said, it looks to be driven by the moderate to high class significantly here. I think it's also then fair to say, if you look at the safety profile, that there are some safety liabilities. We see an opportunity space for Rina-S in that space. We are very confident in our endometrial signal. We are running these trials. We'll obviously have to see what the results are. But all things being equal, we don't see these results in any way that's changing our conviction and our commitment to endometrial, if that makes sense.
Thanks, Tahi. On top of that, Matthew, we have a breakthrough therapy designation from the FDA, also in endometrial. We are quite enthusiastic about what we can do there.
Next question will come from the line of Rajan Sharma with Goldman Sachs. Please unmute your line and ask your question.
Hi, thanks for taking my question. Firstly, I just wanted to clarify, I am not sure if you answered it earlier or addressed it, but do you expect to get priority review on all or any of the three data sets, the phase IIIs that you have read out recently? I realize it is a little bit early, particularly for petosemtamab, but any color there would be helpful. Then just maybe thinking about sort of launch ramp for these assets now that you have the phase III data in hand, can you maybe just help us understand how you think about that? Are these likely to be kind of relatively rapid launches, given the fact that you are potentially changing standard of care?
Then more specifically, how do you think about timing of the profit contributions for each of these launches, particularly in the context of the expiration of your DARZALEX royalty stream? Thanks.
Thanks, Rajan. These are three sharp questions. The first one, priority review, I think it is too early because we are engaging with the regulatory authorities for all three very soon. Now having the data. It is too early, I think, to actually discuss priority review or not. Let us await the outcome of the interactions with the regulators on that. Then the launch ramp, let me move that over to Brad, and maybe you can give some color there, Brad.
Yeah. No, thank you for the question. As kind of mentioned earlier, still extremely confident. We have been building for this for quite some time. We have some pretty good success here with both TIVDAK and EPKINLY, and oncology is a data-driven market. As Jan mentioned with regards to the regulators and the review and all this taking place, what we do know is we are confident in our abilities to date and feel very confident that we will get more into the ramp into the future, maybe as soon as earnings next week and/or even earlier next year.
Thanks, Brad, and thanks, Rajan, for the questions. Let us move on to the next one.
Next question will come from Zain Ebrahim with JP Morgan. Please unmute your line and ask your question.
Hi. Thanks for taking the questions. There are two questions from my side, one on petosemtamab. Just the insight, can you talk through to what extent the data in head and neck gives you more confidence in colorectal cancer, where I think the data that we saw at ESMO was quite strongly highlighted in terms of the ORR holding up in left-sided colorectal. When is the earliest that we can see the colorectal data? Because I think we were really expecting OS today, so that is obviously interim. Do you have a similar sorts of interim in the colorectal phase III? Just tied to that, the KRAS G12D combination that you announced with Incyte, when is the earliest we can see some data from that? What would you say is the key data point that underpinned the confidence from them to sign a collaboration?
Is it that phase II colorectal data, and why did you choose their KRAS G12D? Yeah.
Thanks, Zain, for the questions. I will hand them over to Tahi. Tahi, maybe you can give more color or level of confidence for colorectal cancer with petosemtamab and the combination with the KRAS inhibitor from Incyte.
Yeah, sure. Thank you for the question. Maybe this is a good moment to step back when Jan touched on this. When you think about, at least that is how we do it at Genmab, a drug and its potential, you think about what do you know about the disease, about the patients, about the heterogeneity of the disease, what do you understand about the target, what do you understand about the mechanism of action. Then increasingly also what do you understand about the safety. Without a doubt, having the data now in our hands here on head and neck gives us a better or higher confidence in the mechanism of action and a deeper understanding of the safety of the drug.
I touched on this in the prepared remarks where I said, consistently now we have seen this with these drugs, that the phase IIs that we are generating the data are a pretty good indicator. They are not perfect, of course, because they are phase IIs, but they are pretty robust indicator of how the phase IIIs behave, at least how we interpret them, and then what drives our conviction into the phase IIIs. So just by that readout, of course, our conviction colorectal has already increased, and that is of course then underpinned by the fact that with more patients and more longer follow-up, the colorectal data in front line and second line continues to get better and more robust.
We feel very strong about the colorectal space now, ever more so than before, as a second anchor for petosemtamab, because in the end, and this goes to your second question, we believe it is the best-in-class EGFR bispecific. This is why Incyte was interested in partnering with us, and we were interested in partnering with them because we think their KRAS also has equally the potential. So I think that is why we had the opportunity to come together as two companies, to do something really innovative for patients. As to when we get the data, I do not think there is any place to speculate on this. We will obviously, like we have always done, generate data as expeditiously as possible and then, more importantly, go to next steps. Equally, I would not speculate on what we are doing on colorectal.
All I can say is that we, generally speaking, not only pay a high amount of attention to science, but I think there is equally a lot of pipe and Genmab in the execution and the operationalization of trials. So I think we have now shown repeatedly all there is to say.
Thanks, Tahi. To top it off, Zain, originally Merus made the screening for petosemtamab, which led to the drug being selected for development on colon cancer organoids because of the LGR5 expression on colorectal cancer cells, stem cell-like cells. We think that actually there is a very good rationale and very good data, preclinical data, now supported by clinical data, that colorectal cancer is a very, very good indication for petosemtamab. Then by adding other drugs with other mechanisms of actions like the KRAS G12D inhibitor from Incyte to petosemtamab, that could give very potent novel combinations for therapy in the future. So we are super interested in that, and you will see more examples of novel combinations from us in the coming time.
But always really focused on our anchor positions in certain diseases, like I already explained earlier in my answer to one of the other analysts from Truist. I think we will leave it with that and look under if there is any further questions.
Thanks very much.
That will conclude today's Q&A. I will now hand the call back to Jan for any closing remarks.
Thank you all for joining us today, and thank you for a very lively Q&A. With three positive phase III readouts, new data supporting expansion, and a clear path to launch starting in 2027, we very much look forward to speaking with you all on our Q3 call on November 5th. As always, please don't hesitate to reach out to our investor relations team with any further questions.
Thank you for joining Genmab's investor event. This concludes today's conference call. You may now disconnect.