Full transcript
**Operator:**
Hello, and welcome to the Genmab First Quarter 2026 Financial Results Conference Call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results, unless this is required by law. Please also note that Genmab may hold your personal data as indicated by you as a part of our Investor Relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I would now like to hand the conference over to our first speaker today, Jan van de Winkel. Please go ahead.
**Jan van de Winkel:**
Hello, and welcome to our financial results call for the first quarter of 2026. With me today is our Chief Financial Officer, Anthony Pagano; and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tahi Ahmadi, and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind. Let's move to the first quarter highlights. In Q1 2026, we continue to deliver strong financial performance and make focused progress against our strategic priorities. We grew total revenue by 25%, reflecting continued momentum across our portfolio. And importantly, we continue to invest with discipline in our medicines in our pipeline and on our future growth, fully aligned with our capital allocation priorities. Even with these strategic investments, we grew operating profits. The quarter was also marked by progress in our mission to bring innovative medicines to patients. There are a few highlights I would like to mention. EPKINLY continued to build positive momentum. We were very pleased to see the hospitalization recommendation removed from the third line plus relapse or refractory diffuse large B-cell lymphoma label. And we are on track with the integration of Merus. And we are approaching this with the same focus and discipline that we brought to ProfoundBio. Finally, the breadth, depth and potential of Rina-S continues to increase. The data we presented at SGO in April further support the promise of Rina-S, including in combination with the standard of care therapies such as bevacizumab. We are also making significant progress with our development plan, as you can see on the next slide. We anticipate starting two new Phase III trials for Rina-S in the coming months, underscoring our commitment to a comprehensive development plan across ovarian and endometrial cancers. This includes a Phase III chemo replacement trial in platinum-sensitive ovarian cancer and the first frontline trial for Rina-S in endometrial cancer. As we continue to explore new opportunities for Rina-S outside gynecological oncology, with a Phase II trial seeking Phase II signal-seeking basket trial in advanced gastrointestinal cancers. Finally, I'm pleased to share an update on the ongoing Phase III trial in second line plus platinum-resistant ovarian cancer on the next slide because recruitment has been much faster than expected, the Phase III RAINFOL-02 trial has now completed enrollment. This important milestone brings forward the pivotal Phase III data for Rina-S in platinum-resistant cancer into 2026. This reflects strong investigator engagement to significant unmet medical needs in this indication and the strength of our execution on one of our highest priority late-stage programs. So we can now look forward to two data sets in the second half of this year for Rina-S in platinum-resistant ovarian cancer and the opportunity for broader global regulatory filings earlier than anticipated. For both petosemtamab and EPKINLY, we are maintaining our guidance on the timing of data as you see here. So the key takeaway is that 2026 continues to be a very catalyst-rich year for Genmab. With readouts that have the potential to support important launches in 2027 to bring our antibody medicines to many more patients. With that, I'm very pleased to hand you over to Brad for a review of the recent commercial performance for EPKINLY and Tivdak. Brad?
**Brad Bailey:**
Thanks, Jan. Our proprietary portfolio is off to a strong start here in 2026. Sales for the quarter totaled $176 million, representing 43% growth compared to Q1 last year. Momentum for Tivdak and EPKINLY reflects effective execution by our teams in the new and established markets to expand utilization, accelerate uptake and ultimately reach more patients. This performance combined with our work this year to advance our portfolio and expand our footprint to reach patients in more markets positions us well to deliver on our growth ambitions in 2026 and beyond. In the quarter, EPKINLY continued to gain notable traction as the only bispecific approved in DLBCL and FL indications. Looking globally, EPKINLY grew 52% year-over-year, reaching $137 million in sales. In the U.S., EPKINLY continued to expand across both academic and community settings, and this growth reinforces EPKINLY's value as a single bispecific option in lymphoma indications, which is resonating well with hospitals and health systems. The recent approval of fixed duration EPKINLY plus R2 in second-line FL has been a growth driver for the brand and contributed positively to EPKINLY's growth in the quarter. The recent approval in the quarter. We're seeing physicians increasingly use this chemo-free combination in academic and community sites, supported by unprecedented data demonstrating powerful efficacy and proven safety with seamless subcutaneous administration. Looking ahead, we expect adoption in the community to continue to expand across both FL and DLBCL, bringing EPKINLY-based therapies closer to where patients live. And in March, the FDA revised the label for EPKINLY in third line plus DLBCL to remove the recommendation for 24 hour hospitalization following the first full dose. Now the label advises physicians to assess whether outpatient monitoring for hospitalization is appropriate following the first full dose. We do expect this will further broaden use in the community and in the outpatient setting. Beyond the U.S., performance remains strong. In Japan, EPKINLY continues to stand out as the only bispecific approved in both third line plus LBCL and FL with continued year-over-year growth. The FL launch is building positively on the brand success in large B-cell lymphoma, supported by strong field execution and ongoing site activation. In other markets through our partner, AbbVie, EPKINLY continues to grow with the approvals in more than 65 countries which most have dual indications. For the remainder of 2026, we're focused on maximizing our first-mover advantage in second line FL in the U.S., while preparing for expected approval in this setting in Europe and Japan later this year. and in early lines of DLBCL in the future. As we look ahead, our priority is to accelerate development, including in combination in across early lines of therapy, to continue to build on the already strong clinical data demonstrating EPKINLY's versatility and ultimately establish EPKINLY as the core therapy in B-cell malignancies. Turning now to Tivdak, which is the global standard of care in recurrent or metastatic cervical cancer. Tivdak grew 18% year-over-year, reaching $39 million in sales in the quarter. This reflects both the significant need for therapies that improve survival for women with advanced cervical cancer and our ability to effectively scale commercialization across markets. In the U.S., the brand delivered steady performance and continues to lead the market, a position that has held since launch nearly 5 years ago. Outside the U.S., we're seeing encouraging progress in newer launch markets. In both Japan and Europe, where we lead commercialization directly, growth is being driven by strong field execution and expanding site activation. We also made meaningful progress expanding patient access this quarter. In the U.K., Tivdak launched in February through private prescribing and payer channels, and we're actively engaging NICE and SMC to secure broader availability. At the same time, building upon our work in the U.K. and our established presence in Germany, we're actively preparing for additional launches with infrastructure and teams being established across key European markets, including France, Italy and Spain. Given the significant unmet need in advanced cervical cancer, we look forward to the impact Tivdak to make for more patients as additional markets gain approval and reimbursement. And more broadly, we're building a strong, scalable presence in gynecologic oncology with a meaningful opportunity to expand our impact over time, particularly with Rina-S in the future. To wrap up, our Q1 performance positions us well to sustain momentum in 2026. With continued performance and expanding portfolio, we're well positioned to successfully evolve our business and grow through the decade, supported by the strength of our science, including three potential blockbuster assets with EPKINLY, Rina-S and petosemtamab and our proven ability to scale commercialization and successfully launch in market, we can drive the greatest impact for patients. Overall, we're very pleased with the start to the year and expect 2026 to be another strong year for Genmab. With that, I'll turn it over to Anthony to walk through the financials.
**Anthony Pagano:**
Thanks, Brad. Before diving into the numbers, as we highlighted last quarter, please note that these results and guidance and our remarks exclude the impact of acquisition-related expenses, including amortization. A reconciliation to our reported results is included in the appendix. In Q1 2026, we delivered growth driven by sustained revenues and the solid market performance of our portfolio. Revenue grew by 25%, driven by strong royalties from DARZALEX and Kesimpta. And importantly, this growth was also driven by product sales from our own medicines especially at EPKINLY, continuing to diversify our revenue base. Our investments remain fully in line with our capital allocation priorities, including significant investments for EPKINLY, Rina-S and petosemtamab. And we made these important investments while growing operating profit by 23%. Moving to tax. As you can see in the appendix of this presentation, we have tax expense of around $21 million, which equates to an effective tax rate of 28.9%. And here, I do want to pause for a moment and note that we are currently evaluating the integration of Merus operations from a tax perspective. So our effective tax rate may experience some volatility as integration activities progress. However, we do anticipate that this is going to normalize within the next 12 to 18 months. Overall, the first quarter of 2026 demonstrates the continued strength and quality of Genmab's underlying financial performance. With that, let's move to our 2026 financial guidance. We remain on track to achieve our existing financial guidance with revenue growth that enables strategic investment supporting long-term value creation. At the midpoint, we expect 14% total revenue growth driven by continued momentum in EPKINLY, and our royalty portfolio, further enhancing revenue quality. For operating expenses, we expect to be in a range of around $2.7 billion to $2.9 billion. reflecting planned investments to advance late-stage development for petosemtamab and Rina-S as well as launch readiness activities to support multiple potential product launches. And even with the strategic step up, our guidance delivers on our commitment to maintain substantial profitability in 2026. In summary, our performance in the first quarter of 2026 underscores our ability to deliver revenue growth. Advanced key pipeline assets and maintain strong profitability through disciplined execution. Looking ahead to the rest of 2026, we will continue to build on our momentum through disciplined prioritization of our investments, continued operating discipline and expansion of market opportunities. This positions us for sustained growth and long-term value creation. And on that note, I'm going to hand you back over to Jan.
### Q&A Section
**Jan van de Winkel:**
Thank you, Anthony. Let's move on to our final slide. In the first quarter of 2026, our financial performance reinforced the strength of our foundation and the durability of our growth trajectory. That strength supports a disciplined capital allocation strategy focused on the areas with the greatest potential to create long-term value, accelerating our late-stage pipeline, maximizing the success of our commercialized medicines and ensuring strong launch readiness for future opportunities. And as we further move into 2026, we also remain focused on integrating Merus so that we can capture the full value of petosemtamab. Lastly, we remain committed to deleveraging targeting gross leverage below 3x by the end of 2027, while maintaining balance sheet strength and flexibility. Taken together, Genmab is very well positioned. We have a growing and increasingly diversified revenue base, a powerful late-stage pipeline and multiple catalysts ahead, and our focus remains clear to translate our antibody science and development expertise into meaningful breakthroughs for patients and sustainable long-term value for shareholders. So that ends our formal presentation. Thank you for listening. Operator, please open the call now for questions.
**Operator:**
[Operator Instructions] And now we're going to take our first question. And it comes from the line of Jonathan Chang from Leerink.
**Jonathan Chang:**
On the frontline petosemtamab head and neck cancer study, it looks like the size of the study has been increased. Can you discuss the rationale behind any changes to the study and implications of those changes?
**Jan van de Winkel:**
Thanks, Jonathan, for the question. Tahi, why don't you take the first question by Jonathan?
**Tahamtan Ahmadi:**
Thank you, Jan. Thank you, Jonathan. Yes, so indeed, we increased the size of the frontline study. I think we had in the past indicated that there were thoughts that we had as it relates to the studies that we want to ensure that they have the highest probability of success, details, I don't think are the ones that we want to discuss in the public space. But these trials are being increased based on our insight that we generated during due diligence to ensure that they have the highest probability to our standards. We do not have any anticipation that these changes have any impact on the time lines and steadfast stay with our guidance that one or both of the peto studies will read out this year, and we'll provide data this year.
**Jan van de Winkel:**
Thanks, Tahi. Let's move on to the next question.
**Operator:**
Yes, of course. Now we're going to take our next question. It comes from the line of Zain Ebrahim from JPMorgan.
**Zain Ebrahim:**
We've got two questions. Zain Ebrahim, JPMorgan. First question is just a follow-up on the previous one. And it's helpful that you just said you don't expect the increased size of the first-line trial to impact the timing. But just to understand in more detail why that is given that you're increasing the trial from 500 patients to 700. So have you already completed enrollment of the initial patient population that you're looking to enroll? And how is enrollment progressing? I suppose? And I guess, tied to that, whether the increases for HPV-negative patients that will be helpful to understand as well. Second question is just on EPKINLY first-line DLBCL. You've guided for the readout this year and haven't narrowed out further. So is that the final analysis? Or are we still waiting on the interim?
**Jan van de Winkel:**
Thanks, Zain, for the question. I think, Tahi can handle both of the rest next question and then the EPCORE first-line trial.
**Tahamtan Ahmadi:**
Yes, Zain, sorry, I will have to repeat what I just said, which is, yes, we increased the study from 500 to 700. This was indeed to ensure that this trial has the appropriate data that we need for our probability of success, how we feel about the program and what we understand about the program, and this will not impact the time lines and the what patient populations, it does impact the timing or the status of accrual. I hope you will appreciate that in the context of a very competitive landscape, we are trying to be a little bit more disciplined on what we're sharing when we're sharing it. So two things. It will not change the time lines of what we have guided before, and we continue to stay with the statement that one or both of these studies will read out this year. As it relates to diffuse large B-cell, again, I think there we have also been very disciplined, and I will try to be continuously disciplined today. We have guided that the frontline diffuse large B-cell will read out this year. And we have not commented on interim or final or any of these questions. But we stay with the statement that the diffuse large B-cell study will have a readout this year.
**Operator:**
And now we're going to take our next question, and it comes from the line of James Gordon from Barclays.
**James Gordon:**
James Gordon from Barclays. Two quick ones. One was Rina-S. There's 01 and 02 coming in H2 this year. So, I just wanted to confirm with the two trials reporting so closely together, so Phase II and the Phase III, will you definitely report them as separate results? And if the Phase II is positive, you'll file it and not wait for the Phase III? Or have you discussed that plan with FDA? Or might they say, "Well, if they're so close together, let's see both." And the other one was just more generally, we've seen more data from B7-H4 ADCs in gynecological cancers. How do you think that stacks up versus folate ADCs? There seems to be a few people going for this approach. Is it a different target gyne?
**Jan van de Winkel:**
Thanks, James, for the questions. I will ask Judith to address both the Phase II and Phase III PROC trials, Judith, and then the B7-H4 versus folate receptor alpha ADCs.
**Judith Klimovsky:**
Yes. Thank you for the question. So for the first part, as we highlighted the Phase III accrued ahead of projections. That means that we will have these two datasets this year. Given the change in landscape in PROC, the potential for the Phase III submission and approval becomes more relevant, and this is the plan. So we stay behind our guidance that Rina-S will be launched in PROC in 2027, with these two datasets are supportive, but the main dataset for filing the Phase III that will allow for global submissions. Part one, with regard to the competitive landscape, of course, we are very aware of the B7-H4, the two in investigation, the Glaxo and [ Pukang ]. As we said several times, we know that this is a hypercompetitive space. We stand behind the strength of the data of Rina-S in terms of efficacy, safety, durability of the efficacy and clinical development plan and speed to market. So, more competitors makes it more competitive, but doesn't preclude the fact that we could be not just first-in-class, but best-in-class given the data so far.
**Jan van de Winkel:**
Thanks, Judith. So, it comes down to effective execution, James. And we moved in basically 2 years from 0 Phase IIIs to now 5 Phase IIIs with the news of today.
**Operator:**
And the question comes from the line of Xian Deng from UBS.
**Xian Deng:**
Xian from UBS. So I got a few on EPKINLY frontline DLBCL trials, please. Just wondering, given the typical PFS curve tend to pretty much almost start to plateau after, let's say, 18 months or so in a typical, let's say, frontline DLBCL trial like POLARIX, just purely hypothetically, right, it doesn't have to be anything to do with EPKINLY, just purely from a statistical point of view, do you expect a big change in hazard ratio, when -- during the last 25% of events, just assuming sort of a typical, let's say, frontline DLBCL trial, PFS curve? That's the first question. And the second one is kind of, also on that one, is your study is capped at 30% of IPI Stage 2 patients. So, just wondering if you could give any color on whether you reached this number or your IPI2 patients is actually below this. And just wondering what impact could it have in terms of powering and timing for the primary endpoint?
**Jan van de Winkel:**
Thank you, Xian. I was always teach never to answer hypothetical questions, but I will see. We will test whether Tahi is willing to do that for your first question and then move to the second part as well. Tahi, over to you.
**Tahamtan Ahmadi:**
Yes, thank you. So yes, so what I can say is you're absolutely right. Classical historically diffuse large B-cell, by the way, not only POLARIX. Frontline studies tend to plateau around month 18 to 20. And I think that's my only comment on that question. Particularly speculating what I expect, I don't think it's helpful because I actually don't know, how these curves are going to behave on this trial until we see the data. The cap is also correct. There's a 30% cap. Again, I don't think it's appropriate at this point to talk about what the actual demographics of the study are. The only other point that I think is important to understand the primary endpoint is actually IPI 3 to 5 and if the IPI 3 to 5 passes certain statistics and then read out 2 to 5. And so I think these are my comments on the questions.
**Operator:**
And now we're going to take our next question. And the question comes from the line of Rajan Sharma from Goldman Sachs.
**Rajan Sharma:**
So first one on EPKINLY, just kind of following on the theme there. But what do you think is sort of the relevant benchmark for EPCORE DLBCL-4? That's a second-line trial just in the context of the competitive landscape and some of the potential advantages that EPKINLY has? And then secondly, just on the new Rina-S trial that you announced, RAINFOL-08, is that likely to be a KEYTRUDA combination trial?
**Jan van de Winkel:**
Thanks, Raj, for the question. Tahi, why don't you take the first one and then maybe Judith can go into the new Rina-S trial, one of the new Rina-S trials. Tahi?
**Tahamtan Ahmadi:**
Yes. So, this is a question about the second-line diffuse large B-cell, right? And so I think there's a couple of things to be said about the BMC128 study. First, it is, again, a randomization against R-GemOx. So in the end, that's what the study is going to be compared and everything else is then a cross-study comparison, they're obviously a little bit problematic. But what is the excitement on our end for this particular regimen is that this is a regimen comprised of an oral medication, lenalidomide and a subcutaneous administration that hopefully will show positive data and meaningful positive data for patients and then also comes with a safety profile that is tolerable and differentiated from maybe the chemotherapy combination with R-GemOx, but also improved in efficacy vis-a-vis monotherapy and it's really perfectly suited for the outpatient setting or the community setting. And that's what this trial was intended to do to generate a regimen that is patient-friendly with increased CR rate that then is appropriate and suitable for the community setting. And so, we'll see what the data is, but that's the intent of the trial.
**Jan van de Winkel:**
Thanks, Tahi. And then maybe Judith, on the combination for Rina-S?
**Judith Klimovsky:**
Okay. The question, can you repeat the question, the combination with bev--, did you ask? Yes, the data that we present Okay. So, in terms of combination, the combination with bevacizumab was presented at SGO. And as you can appreciate, if you are there, the safety was very well tolerated. This study was meant only for safety. But in terms of efficacy, we are very pleased with the median number of cycles of 10 and even the fact that 15% of the patients were refractory, 85% of the patients got more than 6 cycles. So, this is with bevacizumab. In terms of pembrolizumab, we have two cohorts ongoing in different settings, and we will communicate the data when the data is a little bit mature and enrolled. So, it's actively enrolling.
**Jan van de Winkel:**
Thanks, Judith. I think that answers your questions, Rajan. Let's move on to the next question.
**Operator:**
And the question comes from the line of Michael Schmidt from Guggenheim Partners.
**Michael Schmidt:**
I had another one on EPCORE DLBCL-2. Maybe just in terms of the enrollment of the study, Tahi, could you just comment on how enrollment has been relative to your expectations when starting the trial? And secondly, I know in the Phase II study, you've evaluated, I believe, a continuous treatment paradigm versus the fixed duration treatment in the Phase III study. And maybe speak to your confidence level that the fixed duration paradigm can replicate the Phase II data.
**Jan van de Winkel:**
Thanks, Michael. Tahi.
**Tahamtan Ahmadi:**
Yes, generally speaking, I think true for BMC128, which is the second-line diffuse large B-cell trial as for the frontline diffuse large B-cell trials that these trials accrued significantly faster than they were initially projected. And I think that's a statement that we've made multiple times. As it relates to the original Phase II data in frontline where we continued epcoritamab monotherapy after R-CHOP for the full year and the design of the trial, the Phase III trial, where it's R-CHOP for six cycles plus EPKINLY followed by two monotherapy cycles of EPKINLY. When we started to generate this data, gosh, in 2020, we were going for the maximum possible exposure if you wanted to. As we generated the data and had the opportunity to see this and also discussed with health authority, it became very clear partially also because of the data that was presented by Faucher on MRD negativity that you don't actually need to expose these patients to continue therapy. Keep in mind, a significant portion of these patients are cured already with R-CHOP. And so that's why we ended up with the design. We feel extremely confident that, if you will, shortening of duration of EPKINLY, as you framed it, doesn't have any impact on the ability of this combination regimen to achieve CR and even MRD negativity at really very high rates as they have been in the public domain and shared. We have a reason, as I've discussed many times, to be confident because you've seen us now in a number of trials with EPKINLY, that the Phase III trials tend to mimic the original first two data just because the mechanism is very predictable for EPKINLY.
**Operator:**
And now we take our next question. And the question comes from the line of Benjamin Jackson from Jefferies.
**Benjamin Jackson:**
I guess just another one, thinking about sequencing of drugs through the lines of therapies in DLBCL. We've heard from some docs that perhaps POLIVY is a very strong salvage option. So, when you're speaking to physicians, are you hearing that there is a preference for bispecifics upfront just naturally because of the order that those drugs can come in? So any thoughts that could be a tailwind there would be useful.
**Jan van de Winkel:**
Thanks, Ben, for the question. Tahi, this one is again for you.
**Tahamtan Ahmadi:**
Well, I think, yes, I'll try to answer Benjamin and maybe Brad has to add something, he may add something to do. But the way I think about this, at least I think this is also how the physicians that we work with and obviously engage think about this. The sequencing of drugs, generally speaking, is a function of efficacy and safety. And in particular, in diffuse large B-cell frontline, where R-CHOP cures a decent amount of patients. I think the anticipation just has to be that this trial that reads out is going to generate data that is going to have a significant impact on the outcomes for patients. And if it does, then that will lead to a natural adoption because the obvious goal in diffuse large B-cell is to avoid the relapsed/refractory setting where things become, generally speaking, a little bit harder to manage.
**Jan van de Winkel:**
Thanks, Tahi. Brad, do you want to add anything to this, the sequencing of the medicines?
**Brad Bailey:**
I think maybe the only thing to add, Tahi said it well, is we do hear from physicians that -- and we've said quite a while all along that the value of bispecifics are certainly in earlier lines of therapy where patients are actually treated closer to their home. We're starting to see this really come to fruition with the advent of the second-line FL launch just late last year, and that's been a key growth driver. The feedback from physicians, hospitals and hospitals and health systems has been extremely positive with not only the unprecedented data, as Tahi referenced, but also the convenience and being able to realize the value closer to the patient's home.
**Jan van de Winkel:**
Thanks, Brad. And then we are super excited about the potential to see both the frontline and the second-line diffuse large B-cell lymphoma data, pretty soon, for EPKINLY or epcoritamab. So, exciting times.
**Operator:**
Now we take our next question and the question comes from the line of Charlie Haywood from Bank of America.
**Charlie Haywood:**
Charlie here with Bank of America. I have two, please. First is on your peto Phase II OS rates. Just wondered if you've taken a 2-year OS cut and any directional comment on how that OS curve has trended relative to the first 12-month data that we've seen? Would it be fair to think a similar trajectory to what you've seen at year one, or could you actually see similar to what your competitors saw with faster first 12-month curve decline and then stabilize more thereafter? And then will that data be presented any time? And then second one is just on Rina-S in second-line endometrial. Could you just remind us on time lines of that data? And then frame your excitement in that relative to the more imminent second-line PROC setting, I think potential smaller patient number there, but possibly higher unmet need given lack of your limited ADC presence to date?
**Jan van de Winkel:**
Thanks, Charlie, for the questions. Tahi, why don't you take the first one on peto and then Judith can handle the question on Rina-S and endometrial cancer second line.
**Tahamtan Ahmadi:**
So if I understood your question correctly, you were asking if we are intending to update the Phase II dataset for peto in second line or in front line?
**Charlie Haywood:**
In front line, yes.
**Tahamtan Ahmadi:**
Front line. Well, I mean, we will follow at some point we want to update that curve and presented in the data, but I think the more meaningful readout is going to be the actual study. So we said one or two of them will readout this year. And so that is probably the more meaningful data set and relevant to the brand and to the company.
**Jan van de Winkel:**
Thanks, Tahi. And then Judith, maybe something more on the time line for second line plus endometrial and Rina-S.
**Judith Klimovsky:**
Yes. No, thank you for the question. And as you know, the Phase III is actively enrolling. We haven't guided the investor community about readout. But what I can say is the activation and enrollment is going very well. And just something to add to Tahi's first question on the first-line peto-pembro combination. I think that it's very apparent what we already presented with 17 months follow-up, which is not negligible. And at this time point, around 30% was censored and alive. And this gives you a kind of magnitude of duration. And as Tahi alluded, now we are fixated on the Phase III which are much more relevant. But I think that the data presented at ASCO is a very good representation of the durability of the effect.
**Jan van de Winkel:**
Thanks, Judith. Thanks, Charlie. Let's move on to the next question.
**Operator:**
And now we're going to take our next question. And it comes from the line of Eva Fortea-Verdejo from Wells Fargo.
Eva Fortea-Verdejo: A quick one from us on peto as it relates to CRC development. How should we be thinking about timing for any announcements for this tumor type? And are you exploring other mechanisms that would make sense to combine with beyond chemo?
**Jan van de Winkel:**
Thanks, Eva, for the question. I think probably Tahi can handle this one, CRC updates for peto in the second half.
**Tahamtan Ahmadi:**
Yes. So look, we've answered this question a couple of times. We obviously have looked at the CRC data. We have generated more CRC data. We like what we saw early on in due diligence. We continue to like what we see. And we will update you a little bit closer to -- similar to what we did with Rina-S when these studies then go into the public domain on our next steps. So, there will be more to come at some point. As it relates to combination with other mechanisms, there's a number of interesting things that are happening in this space in a subset of patients. And obviously, we are aware of that, and there is a good rationale to combine with peto. So more to come on that end as well.
**Jan van de Winkel:**
Thanks, Tahi. So, we keep the cards close to our chest, Eva, because it's a very exciting area and also a very competitive area. So, we want to be first and hopefully best here.
**Operator:**
Now we take our next question. And the question comes from the line of Matthew Phipps from William Blair.
**Matthew Phipps:**
I'm going to harp on the petosemtamab enrollment as well. There are some rumors on whether or not to increase the 200 patients would focus exclusively on HPV-negative patients. So, maybe just remind us on your thought on the breakdown of patients by that baseline characteristic? And then has the number of patients needed to conduct the ORR analysis changed? Or is this really just patients for the OS analysis?
**Jan van de Winkel:**
Thanks, Matt, for the questions. Tahi, can you address both of these questions and give some perspective?
**Tahamtan Ahmadi:**
I'm going to answer your questions. Good question. I will not go into the specifics. I will stick with the line that I used before, that the increase in the end of the study was intended to increase the overall probability of success of the study as we see it based on what we understood in due diligence. These were decisions made already back then and that we continue to understand about peto and that none of the things that we're doing right now has any impact on the time lines for the readouts that we anticipate.
**Operator:**
The next question comes from line of Yaron Werber from TD Securities.
**Yaron Werber:**
Tahi, I'm just going to maybe ask another question on the LiGeR program, maybe a little bit broader. Do you plan on filing with both studies? Or would you file presumably in second-line potentially first and then frontline? And when you do release the data by year-end, do you think it's going to be -- let's assume it's going to be in second-line first because you're not continuing to not over enrolling that study. Would you have kind of at least the interim OS, and would it even be mature OS at that time?
**Jan van de Winkel:**
Thanks, Yaron. Tahi, that's another sharp one.
**Tahamtan Ahmadi:**
A very good question. Unfortunately, my answer will be the same as I did before. Right now, all we guide and have been consistently guiding that we indeed expect one or more of these studies to read out this year. And I will not comment on which one first or second or together all these permutations that may exist.
**Jan van de Winkel:**
So more to come later, Yaron.
**Operator:**
And the question comes from the line of Suzanne van Voorthuizen from Van Lanschot Kempen.
Romy O'Connor: This is Romy on for Susanna. One on EPKINLY. So, looking ahead to the Phase III readout in first line, we recently did a survey, which found that doctors are projecting EPKINLY even before seeing this data to be the most dominant first-line option. I just want to know your thoughts on what you see as the most important features of EPKINLY specifically that drives this enthusiasm.
**Jan van de Winkel:**
Thanks very much for referring to that very nice survey. We like the data, of course. And I will ask Tahi to sum up basically what the key parameters are here for why EPKINLY is so advantageous in the first-line setting according to the survey.
**Tahamtan Ahmadi:**
Yes. So I mean this is like -- if you step back, this is also something that we talked about from the very beginning when we engaged on the development program with EPKINLY that the CD3xCD20 mechanism of action of EPKINLY is a unique and very powerful single-agent mechanism that comes with a safety profile that predominantly is infusion-related reactions and then otherwise, it's extremely well tolerated. And because of subcutaneous administration, also convenience of administration that makes it easy for the patient and also for the providers. And so if you start combining EPKINLY and CD3xCD20 with chemotherapy, we have already seen this in all kinds of Phase II studies or Phase III studies that tends to be a mechanism that is very well combined with chemotherapy and at least additive. And so that's, I think, what's driving the enthusiasm of frontline in terms of what the expectation is around data. And then what drives EPKINLY specifically, of course, is the observation that, A, in very high likelihood will be the first study to read out in frontline diffuse large B-cell with a significant time advantage. And B, it is the one that comes with a subcutaneous administration. And as Brad was saying earlier, in frontline diffuse large B-cell, the vast majority of these patients are actually treated in the community setting. And so the fact that there is now a potential readout on a drug that is available for these physicians and these patients in this particular setting, particularly in the U.S. health care system, the only one that is labeled without restrictions on where it can be provided to the patients. I think that is what's driving the entire enthusiasm on that particular study. And I think why we had, I don't know, six or seven questions from you guys on this study.
**Operator:**
And now we're going to take our next question, and it comes from the line of Victor Floch from BNP Paribas.
**Victor Floch:**
Just one on EPKINLY. So, I mean EPKINLY has reported a decent Q1 performance. I was just wondering whether this is driven by the recent label change in the U.S. So, I mean, I was just wondering if you've seen like a material uplift in the academic setting and whether you can comment on the key hurdles that you need to clear to further drive penetration in this setting?
**Jan van de Winkel:**
Absolutely, Victor. So, good question. So, Brad you can handle both of these.
**Brad Bailey:**
Yes. No, I think, first of all, thanks for the question. And the strong start to the year is certainly evident by the profile being appreciated by physicians as well as health systems. primarily being looked at as the only bispecific the dual indication. And the proven efficacy piece is certainly extremely important as well as the subcutaneous administrations, which is what Tahi had mentioned well. Now, as it relates to the moving forward into earlier areas, the ability to, again, have all of these ingredients in place, moving quickly into earlier lines, featuring combination as well as fixed-dose options is extremely important. But then also, as you mentioned, as it relates to the performance of second-line FL, we're seeing as a key part of this driver of performance. And then the hospital removal of potential hospitalization data has been very well received. And again, looking to remove just additional barriers to be able to treat patients closer to where they live in the ways that you're seeing with this extremely important profile from an efficacy, safety and deep durable responses along with subcutaneous administration.
**Operator:**
And the question comes from the line of Kalpit Patel from Wolfe Research.
**Kalpit Patel:**
For EPKINLY, the EPCORE DLBCL-2 trial in frontline setting, what PFS hazard ratio do you think you need to be clinically meaningful, especially given the context behind POLARIX study? And then do you also need to show an OS benefit to potentially drive more meaningful commercial uptake in the first line?
**Jan van de Winkel:**
Thanks for the questions. Tahi, you can address both of these.
**Tahamtan Ahmadi:**
Yes. So, this question like what hazard ratio we are expecting has come up a lot and essentially, it doesn't make much sense to speculate. What we have said is that based on the public data that is available in Phase II, there is, of course, and you heard this in the other question earlier, expectation and enthusiasm about the possible readout of that study. So, Phase IIIs have in the past on EPKINLY tended to mimic close Phase II data, as I said, because it's a mechanism of action that's very predictable. And so we're excited as you are awaiting the readout and of course, are very enthusiastic of how positive this trial could be, but we will see what it is when we have it. As it relates to OS, now we all know from the ODAC that the FDA will approve frontline diffuse B-cell regimens even without OS benefit. I said in the past, the ability of showing OS benefit, of course, is becoming a little bit more challenging in diffuse large B-cell in general because of the increasing availability of very effective salvage therapies for particularly the worst patients refractory, they have access to CAR T. The bispecifics that are also now penetrating second-line and are already very much available in third-line. Having said all of that, it's also a function of the effect size that you have on PFS, meaning the larger the PFS hazard ratio benefit becomes the larger the opportunity to show an OS benefit. That's kind of like broadly speaking, how we think about it.
**Operator:**
Yes, of course. And now we're going to take our last question for today. And it comes from the line of Judah Frommer from Morgan Stanley.
**Judah Frommer:**
Just a follow-up on the peto trial upsizing. Have you said whether that upsizing will occur at already enrolled centers in the trial? Will you be adding any investigational sites? I'm just curious if you are -- if any other EGFR bispecifics might be being studied at those sites and what reception might be?
**Jan van de Winkel:**
Thanks, Judah, for the question. Tahi, can you address the recruitment and the setting for the peto trial?
**Tahamtan Ahmadi:**
Yes. What I will answer, Judah, is that this amendment that increases the N had no impact on additional sites or need for any additional sites. The study is enrolling extremely well. So that's why it won't have an impact on anything.
**Jan van de Winkel:**
Thanks, Tahi. And that, I think, addresses the last question of today. So thank you all for calling in today. And if you have any additional questions, please reach out to the Investor Relations team of Genmab. We very much look forward to speaking with all of you soon in this super exciting year for the company. Thank you.
**Operator:**
This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.
