Genmab A/S Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 6, 2026

Key Takeaways

  • Positive Sentiment: Genmab raised its 2026 guidance, now expecting revenue of DKK 4.3–4.5 billion and operating profit of DKK 1.1–1.4 billion. Revenue growth at the midpoint is projected at 19%, while operating expenses rise only 2%, highlighting expected operating leverage.
  • Positive Sentiment: First-half proprietary-product sales increased 37% to DKK 396 million, led by EPKINLY sales growth of 48% to DKK 312 million. Management cited accelerating U.S. community adoption, broader site activation, and strong uptake of the second-line follicular lymphoma regimen.
  • Positive Sentiment: Genmab reported statistically significant, clinically meaningful progression-free-survival results from the phase III EPCORE DLBCL-2 study and received European approval for EPKINLY plus lenalidomide and rituximab in second-line follicular lymphoma.
  • Positive Sentiment: Petosemtamab is being expanded into two global phase III colorectal cancer trials—frontline and second-line—in combination with chemotherapy. Management also expects frontline head-and-neck data in the fourth quarter and is positioning the asset as a potential multi-indication growth driver.
  • Neutral Sentiment: Several major catalysts are expected in the coming quarters, including Rina-S phase II and III ovarian-cancer data and frontline EPKINLY data in the fourth quarter, while petosemtamab’s second- or third-line head-and-neck readout is now expected in the first quarter of 2027. Overall-survival data for the EPKINLY DLBCL study remain immature, and outcomes for these late-stage programs are still subject to clinical and regulatory uncertainty.
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Earnings Conference Call
Genmab A/S Q2 2026
00:00 / 00:00

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Operator

Hello, welcome to the Genmab first half 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 beliefs, anticipate, 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. Today's presentation will also include comments on certain non-IFRS financial measures, which management uses to describe the company's baseline performance and which supplement, but do not substitute for, the comparable IFRS measures. We encourage you to review our full financial statements and publicly filed reports, not to rely on any single financial measure.

Operator

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
President and CEO at Genmab

Hello, everyone, welcome to our financial results call for the first half of 2026. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tahi Ahmadi . For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky. As the operator said, we will be making forward-looking statements, please keep that in mind during the call. As we pass the midpoint of the year, I can tell you we are in a really good place. We have been clear about what we set out to do, accelerate our late-stage pipeline, maximize our commercialized medicines, stay disciplined with our capital. That is exactly what we have been doing. We grew total revenue by 25%, driven by continued momentum across our portfolio.

Jan Van de Winkel
President and CEO at Genmab

Even as we have made focused and strategic investments in our late-stage programs, in launch readiness, in the integration of Merus. We did all this while growing operating profit. To me, that says a lot about the quality of our business. Beyond financial performance, I'm enthusiastic about our recent pipeline progress. Let me walk you through the highlights. In June, we announced positive top-line results from the phase III EPCORE DLBCL-2 trial, which showed statistically significant, clinically meaningful improvement in progression-free survival. What is important about these results is what they demonstrate about epcoritamab more broadly. It is growing evidence of the versatility of epcoritamab-based combinations across multiple lines of therapy. This data was followed by the European approval of EPKINLY plus lenalidomide and rituximab for the treatment of follicular lymphoma in the second line setting.

Jan Van de Winkel
President and CEO at Genmab

This makes EPKINLY the first and only bispecific-based therapy approved in Europe for this indication. Our presentations at medical conferences throughout the quarter have highlighted the strength of our portfolio. We are looking forward to sharing with you petosemtamab data with updated results in colorectal cancer presented at ESMO in October. Based on this promising data, we are continuing to build momentum for petosemtamab. We are initiating two new phase III studies in colorectal cancer. Tahi will share more detail on them in just a moment. Let's turn to the catalysts we continue to look forward to this year on the next slides. As we move into the second half of the year, we are now in a position to provide some clarity on the timing for our highly anticipated data readouts.

Jan Van de Winkel
President and CEO at Genmab

For Rina-S, we anticipate both phase II and phase III platinum-resistant ovarian cancer datasets will be available in the fourth quarter. For petosemtamab, we are eagerly awaiting the readouts for both studies. With better visibility, we can now say that the full line study is expected to readout in the fourth quarter, while the second or third line study is anticipated to readout in the first quarter of 2027. Finally, for EPKINLY, we anticipate that top-line data from the frontline EPCORE DLBCL-2 study, which will be based on an interim analysis, will also be available in the fourth quarter. What this means is that for each of our late-stage programs, we remain on track for phase III readouts in the second half. Potential approvals and launches in 2027. This is what we have been building towards, and it reflects our focused execution. Exciting times ahead.

Jan Van de Winkel
President and CEO at Genmab

I would like to hand you over to Tahi to walk you through the details of the phase III colorectal studies. Tahi, the floor is yours.

Tahi Ahmadi
Chief Medical Officer at Genmab

Thank you, Jan. We are pleased to share our plans for petosemtamab in colorectal cancer, which build on our ongoing phase III trials in head and neck cancer. As you can see on the slide, there are a significant number of patients impacted by these diseases. As you know, petosemtamab is a EGFR LGR5 bispecific antibody. The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care. LGR5 is a marker of cancer stem cells in this disease. Combination of EGFR and LGR5 targeting has shown to be more effective than cetuximab in various preclinical models in RAS/RAF wild-type colorectal cancer. The early clinical data have been very encouraging. We will be able to show more on this at ESMO in October.

Tahi Ahmadi
Chief Medical Officer at Genmab

Based on this promising data, we are initiating two phase III studies, one in front line and one in second-line colorectal cancer. For front line, we have already initiated a phase III randomized trial, open label, a global trial that is designed to assess the efficacy and safety of petosemtamab plus investigator choice chemotherapy of either mFOLFOX6 or FOLFIRI. A first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer that is RAS/RAF wild type. It will thus be versus the standard of care, namely cetuximab plus chemotherapy. For the second-line colorectal cancer patients, the phase III trial will be similarly a randomized open label and global trial. This trial is designed to assess the efficacy and safety of petosemtamab plus investigator choice therapy of either modified FOLFOX6 or FOLFIRI as a second-line therapy in patients with unresectable metastatic colorectal cancer that are RAS/RAF wild type.

Tahi Ahmadi
Chief Medical Officer at Genmab

Here the trial will be versus the standard of care, which is cetuximab or bevacizumab plus chemotherapy. Taken together with our two ongoing phase III trials in head and neck cancer, our plans to expand into locally advanced head and neck cancer and the encouraging data we continue to generate, petosemtamab is rapidly emerging as a generally multi-indication asset with the potential to reach a significant number of patients. With that, I'm pleased to hand over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK.

Brad Bailey
CCO at Genmab

Thanks, Tahi. Our proprietary portfolio performed incredibly well in the first half of the year. Sales totaled DKK 396 million, representing 37% growth compared to the same time last year. These results demonstrate the strength of Antibody Sciences as well as the strong execution by our teams to bring our medicines to patients around the world. The performance we delivered in the first half of 2026 reflects growth for both EPKINLY and TIVDAK globally. We're very pleased with how EPKINLY is performing. In fact, EPKINLY grew to DKK 312 million in sales for the first half of the year, representing a 48% increase year-over-year and a 28% increase in the quarter. In the U.S., we delivered accelerated growth with increases in both new patient starts and new site activations. The launch of chemo-free fixed-duration EPKINLY plus R-squared in second-line FL has been going extremely well with rapid uptake across sites.

Brad Bailey
CCO at Genmab

This contributed positively to our growth in the first half of the year and suggests that EPKINLY is becoming a preferred regimen in this setting. We've also seen increasing growth in the community this year, with the majority of new sites activated coming from community practices, and now over 90% of our key customers are ordering for two or more sites. This is driven by EPKINLY's differentiated dual indication label without a recommendation for 24-hour hospitalization and broad adoption of EPKINLY plus R-squared in second-line FL, which is leading more sites to utilize EPKINLY across its approved indications. This performance reflects strong execution by our field teams, physician confidence in EPKINLY's differentiated clinical profile, and the value of using a single bispecific option across DLBCL and FL.

Brad Bailey
CCO at Genmab

The uptake we're seeing in the community, with more physicians gaining experience using EPKINLY at sites of care closer to where patients live, is a positive indicator as we look ahead to potential launches in early lines of DLBCL. Outside the U.S., performance remains strong. In Japan, EPKINLY continues to build on its compelling position in the market with approvals in both DLBCL and FL. We expect the second-line FL launch, anticipated later this year, will serve as another growth driver for the brand. Through our partner AbbVie, EPKINLY's global footprint continues to expand, including recent approvals for EPKINLY plus R-squared in second-line FL in Europe and China. Overall, we're really pleased with EPKINLY's growth globally, and particularly in the U.S. and Japan, where we book sales. The momentum we are seeing today reinforces our confidence in EPKINLY's long-term growth opportunities, especially its potential in early lines of therapy.

Brad Bailey
CCO at Genmab

As we look towards the back half of 2026, we're focused on continuing to grow EPKINLY and strengthening our leadership in the market by maximizing our first-mover advantage in second-line FL and preparing for anticipated launches in early lines of DLBCL in the future. Turning briefly to TIVDAK. TIVDAK totaled DKK 84 million in sales during the first half of the year, driven by continued performance in the U.S. as well as in our launch markets in Japan and Europe. In markets where TIVDAK is available, we saw expanding site activations underscoring the continued need for treatments that can improve survival for women with advanced cervical cancer. As part of our work to bring TIVDAK to more patients, we secured reimbursement for TIVDAK in the U.K., and the conversations continue to progress in additional markets.

Brad Bailey
CCO at Genmab

Looking ahead, we remain focused on continuing to scale our commercialization capabilities to support TIVDAK launches in new markets while building on that foundation to prepare for the anticipated launches of Rina-S and petosemtamab in the future. Heading into the second half of 2026, we're extremely pleased with the performance across our portfolio. Our performance to date, combined with meaningful momentum underway across the business to advance our pipeline and expand our commercialization footprint, positions us well to grow adoption of our approved medicines to benefit more patients, and successfully launch additional indications and new medicines as we look towards the end of 2026 and into 2027 and beyond. With that, I'll turn it over to Anthony to walk us through the financials.

Anthony Pagano
CFO at Genmab

Thanks, Brad. The first half of 2026 demonstrated the continued strength of our business with revenue growing 25% year-over-year. Beyond the headline 25% revenue growth, I'd highlight two characteristics of our performance. First, high growth, and second, broad-based growth. Starting with the high growth. DARZALEX increased 21% year-over-year while worldwide EPKINLY net product sales increased 48%, reflecting continued commercial momentum and strong execution. Beyond these two brands, the remainder of our portfolio increased 35% year-over-year. Turning to broad-based growth. Approximately half of our year-over-year revenue growth came from DARZALEX. Impressively, the other half was generated by EPKINLY and the remainder of our portfolio. Taken together, these results demonstrate that our business is becoming more diversified and more durable. That evolution continues to strengthen the quality of our revenue base.

Anthony Pagano
CFO at Genmab

The strength of our business also provides the financial flexibility to continue investing behind our highest value growth opportunities, including EPKINLY, Rina-S, and petosemtamab. At the same time, we grew adjusted operating profit by 18%. Together, these results demonstrate that Genmab can increase investment while continuing to expand profitability. Now, before moving to our updated 2026 guidance, let me briefly comment on tax. Our effective tax rate for the first half was 3.6%, primarily reflecting the ongoing integration of Merus and related recognition and utilization of deferred tax assets. As shown in the appendix to the presentation, this equates to tax expense of DKK 13 million. Now, as we've discussed previously, we continue to evaluate the integration of Merus from a tax perspective. As a result, our effective tax rate may continue to fluctuate as those integration activities progress.

Anthony Pagano
CFO at Genmab

We expect our effective tax rate will normalize over the next 12-18 months. Now with that, let me turn to our updated 2026 financial guidance. The strength of our business and the financial flexibility it continues to create are reflected in our updated 2026 financial guidance. Compared with our previous guidance, we now expect to deliver 5% higher revenue and 7% higher operating profit while increasing investment by only 2%. This demonstrates the operating leverage inherent in our business. Starting with revenue, we now expect full-year revenue to be in the range of DKK 4.3 billion-DKK 4.5 billion, representing 19% year-over-year growth at the midpoint. This compares with 14% under our previous guidance. This improved outlook reflects the continued strong performance of both DARZALEX and EPKINLY, with the DKK 195 million increase at the midpoint being approximately equally split between DARZALEX and EPKINLY. Now turning to operating expenses.

Anthony Pagano
CFO at Genmab

We are continuing to invest behind our highest value growth opportunities. Our updated operating expense guidance includes additional investment to maximize the long-term value of our portfolio, including the two new phase III petosemtamab studies we announced today. Even with these incremental investments, we are only increasing our OpEx guidance by 2%, resulting in a new midpoint of DKK 2.88 billion. Finally, operating profit is now expected to be in the range of DKK 1.1 billion-DKK 1.4 billion. Importantly, the majority of our revenue outperformance continues to translate into higher operating profit while preserving our ability to invest behind our highest value growth opportunities.

Anthony Pagano
CFO at Genmab

In summary, our first-half performance provides further evidence of the strength of our business. We are delivering high growth, broadening our revenue base, investing behind our highest value opportunities, and continuing to expand profitability. Together, this positions us well to deliver sustained growth and long-term value creation.

Anthony Pagano
CFO at Genmab

Now on that note, I'm going to hand you back over to Jan.

Jan Van de Winkel
President and CEO at Genmab

Thank you, Anthony. Let's now move to our final slide. Looking at the first half overall, we've had a strong six months, both scientifically and financially. Our disciplined capital allocation strategy remains focused on the areas with the greatest potential to create long-term value. When I look at where we are, the revenue base we have built, our versatile and promising product pipeline, and what is still to come in the coming months, I'm super excited. That now ends our formal presentation, and thank you for listening. Operator, please open the call for questions.

Operator

Thank you so much. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for your name to be announced. To withdraw your question, please press star one and one again. Please stand by while we compile the Q&A roster. This will take a few moments. Now we're going to take our first question. It comes line of Zain Ebrahim.

Zain Ebrahim
Zain Ebrahim
Analyst at JPMorgan

Hello.

Operator

Your line is open. Please ask your question.

Zain Ebrahim
Zain Ebrahim
Analyst at JPMorgan

Hi, everyone. Thanks for taking the question. Zain Ebrahim, JPMorgan. First question is on the petosemtamab second line trial, which way you're now guiding for the readout in Q1 in 2027. Just wanted to understand what's driving the slight delay to the readout in Q1. Is it the change in the primary endpoint variable survival? Is it the upsizing of the trial? How is recruitment progressing for the second line trial relative to your expectations? I think the slide suggests it's still recruiting. Just any updates there would be helpful. My second question is on EPCORE DLBCL-4. Quite a strong PFS outcome, but just any sense of what you've seen so far on overall survival, or was it just too immature to see a trend at this point?

Zain Ebrahim
Zain Ebrahim
Analyst at JPMorgan

What's the latest feedback you've had from the FDA on whether the second-line trial or the first-line trial could be used as a confirmatory trial?

Jan Van de Winkel
President and CEO at Genmab

Thank you, Zain, for the questions. I think I will hand them both over to Tahi. Maybe start, Tahi, with the second line trial for petosemtamab and head and neck cancer then move on to DLBCL-4 to address some of the points raised here.

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah, thank you for the question. Let's take the petosemtamab first. As you correctly noted, the endpoint is overall survival, this is an event-driven projection for when we have the data and the trial is fully enrolled. That was to that question. We're just updating based on what we see when we expect to have the top-line results, which is now in the first quarter of next year. As it relates to the second line, third line lin epcor combination, you noted correctly, that this is a very exciting PFS benefit for patients for what is a chemo-free regimen of a pill with a subcutaneous injection, with a really impressive CR rate for patients. That's the most meaningful kind of data point. We are really excited about the data.

Tahi Ahmadi
Chief Medical Officer at Genmab

The OS, of course, at that point, is totally immature, which is why it's not yet been reported. The data will be presented in an upcoming conference. We'll have a chance to look at it in a little bit more granular detail. As it relates to the part of your question, for the confirmation of the indication that is already approved, we are of course in very active engagement with the agency on all kinds of fronts. Whether the frontline or the second line trial is going to be the confirmatory trial, I think that's an ongoing discussion right now, to a degree, also depends on how are the results of the frontline trial are going to be. This is all there is to say at this point. We have an active process, active engagement, and it'll be one of the two.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Tahi. Let's hand the question back to the operator, and then see whether there's another one.

Operator

Yes, of course. Now we're going to take our next question. Just give us a moment. The question comes line of Michael Schmidt from Guggenheim Partners. Your line is open. Please ask your question.

Michael Schmidt
Analyst at Guggenheim Partners

Hey, thanks for taking my questions. I had one on EPCORE DLBCL-2, and I'm just trying to wrap my head around the timing of the interim analysis in the fourth quarter this year. Based on our work, we think this should have already occurred at some point last year. How do you explain this one-year delay, essentially, of the interim efficacy analysis, especially given that the study enrolled faster than expected, I believe?

Jan Van de Winkel
President and CEO at Genmab

Thanks, Michael, for the question. Tahi, can you address this one?

Tahi Ahmadi
Chief Medical Officer at Genmab

Let's start first. We are very excited about the results of this trial, as they be going to read out next quarter. This is the most important study, I think it is fair to say, within the epcoritamab franchise. There is exciting phase II data that is in the public domain. Last year and the year before presented at ASH around the combination of epcor with R-CHOP that showed really unprecedented CR rates, which is driving the excitement for the results of this trial. The only other thing to say is that we have been now confirming that this is based on the interim and that it will be top-lined next quarter. I think we should probably leave it at this point. Once we have the data in our hands, we can have a good conversation about all of these other questions that may arise.

Tahi Ahmadi
Chief Medical Officer at Genmab

For now, next quarter, looking forward to it.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Tahi. Thanks, Michael, for the question.

Operator

Thank you. Now we're going to take our next question. The question comes line of James Gordon from Barclays. Your line is open. Please ask your question.

James Gordon
James Gordon
Analyst at Barclays

Hello, James Gordon from Barclays. A question, a couple of clarifications, please. One question was on petosemtamab. The first-line trial is now going to report before the refractory trial, presumably because the first line has an OR primary with interim OS, whereas the refractory trial is more mature OS. For the first-line trial that I think we're going to get in Q4, how mature will the interim OS be when you report it that you plan to file? Do you think the first line or refractory is a higher bar in terms of being successful? It was just two clarifications. One was for EPKINLY and where we're going to get the interim in the first-line trial in Q4.

James Gordon
James Gordon
Analyst at Barclays

If it doesn't work at interim, will you tell us that and say that the trial is going to continue on to the final data, or it's just we won't hear anything, and if we don't hear anything by the end of the year, we'll have to assume that it didn't work interim, how that works, please. The other clarification was just, for Rina-S and PROC, the 01 and 02 trials, they're both in Q4, phase II and a phase III. Are we going to get two different readouts, or it's the phase III that's material because that's what you're filing, we'll just get all the data together?

Jan Van de Winkel
President and CEO at Genmab

Thanks, James, for the questions and the clarification requests. The first two I'm going to hand over again to Tahi, Judith can deal with the phase II and phase III data for PROC for Rina-S. Tahi, why don't you start with petosemtamab and the frontline trial?

Tahi Ahmadi
Chief Medical Officer at Genmab

It was actually, I think, I don't know, I stopped counting at three, I'll try to address all of the points that were made and asked. The first thing is, on the petosemtamab trial, right, we've from the beginning stuck to the guidance that had come from us, one or both going to read out this year. Now we are being more precise that we actually will have the top-line results on the frontline indication, which is very exciting because this is obviously the one indication that has a significantly larger impact on patients, larger population, and we believe this is going to be very exciting data when we have it to present and discuss. As it relates to what will be meeting statistical significance, we don't have any visibility to this, so this would be all speculation.

Tahi Ahmadi
Chief Medical Officer at Genmab

I don't think this makes any sense. We'll have that discussion when we have the interim results in our hands. What we are saying is we will have an interim data that we expect to be the basis for filing, in the next quarter on this frontline petosemtamab trial. I think you asked about whether we believe that OS in one indication or the other is like a higher bar. I don't really know how to answer this, to be honest. I think having an OS benefit is always a high bar, and we have a very high confidence in petosemtamab being able to provide an overall survival benefit for patients in frontline and in second line.

Tahi Ahmadi
Chief Medical Officer at Genmab

This is underwritten to a degree by these two BTD indications, the data sets in a public domain, is of course also underwritten by our continuously growing confidence in this very exciting drug that we believe will have a significant impact for patients in head and neck, in these two studies that are already operationalized. In colorectal, where we are today announcing that we're going to start two phase III and any future trials. It's a very exciting drug. We're really looking forward to the data in frontline, we can have a more detailed discussion on what actually the data will be.

Jan Van de Winkel
President and CEO at Genmab

There was a question, Tahi, on epcoritamab, in the frontline study, when we wouldn't hit the interim, what would happen then with the petosemtamab trial?

Tahi Ahmadi
Chief Medical Officer at Genmab

I think we should stick with what we just said. What we expect to present the interim data next quarter.

Jan Van de Winkel
President and CEO at Genmab

All right. Very good. Let's stay with that. Judith, maybe the phase II and phase III data sets for Rina-S and PROC, a bit more color there. Judith, are you there?

Tahi Ahmadi
Chief Medical Officer at Genmab

If she's unmuted, I can take that too.

Jan Van de Winkel
President and CEO at Genmab

Okay. Why don't you take it, Tahi?

Tahi Ahmadi
Chief Medical Officer at Genmab

There will be indeed, as you said, there's a phase II in PROC, and then we already talked about that there's also a phase III. Both of these data sets, of course, will be made available at the time that we get them and then have the top-line results.

Jan Van de Winkel
President and CEO at Genmab

I think that should do it for now, Tahi Thanks.

James Gordon
James Gordon
Analyst at Barclays

Thank you.

Jan Van de Winkel
President and CEO at Genmab

Thanks, James.

Operator

Thank you. Now we're going to take our next question. The question comes from the line of Gregory Renza from Truist. Your line is open, please ask-

Analyst at Truist

Hi. Thanks so much for taking our question. This is support line for Greg. I have one for petosemtamab in head and neck. With competitors advancing quickly in the second-line third-line setting ahead of your action to read out in the first quarter of next year, what efficacy and durability profile would petosemtamab need to show to remain competitive? Thanks so much.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Greg, for the question. Tahi, can you take this one?

Tahi Ahmadi
Chief Medical Officer at Genmab

Sure. I think you're alluding to the J&J filing. I think one thing to say is that we just had a conversation about this and that the second-line data set will be a phase III with an overall survival benefit, and that is a, of course, completely significantly different data set, as a OR duration of response data set that may form the basis of accelerated approval, as it is for amivantamab. We remain very steadfast in our statement that we believe petosemtamab is the best-in-class, second-generation EGFR bispecific based on all the data that we have seen in head and neck, but also outside of head and neck.

Tahi Ahmadi
Chief Medical Officer at Genmab

The totality of our data, the fact that we will have a front-line indication with pembrolizumab, that we are seeking with the phase III readout next quarter, then a overall survival phase III readout in the first quarter of next year. I think this is a very compelling and comprehensive dataset across these two studies, monotherapy, second-line, third-line, combination with pembrolizumab front-line. That is going to really underwrite our ambition in head and neck. We're very comfortable with our position and where we are. The expectation is that these trials are going to provide significant data that will hopefully have significant impact for patients with head and neck.

Jan Van de Winkel
President and CEO at Genmab

Thank you, Tahi. Thanks, Greg. Let's move on to the next one.

Operator

Thank you. The next question comes line of Xian Deng from UBS. Your line is open, please ask your question.

Xian Deng
Xian Deng
Analyst at UBS

Hi. Thank you for taking my question. I guess I'll just try my luck a little bit on the EPKINLY frontline trial. Given the interim two has not passed, this really suggests that events are happening really a lot slower than expected. Just wondering, is there any reason that you could think of that you can suspect that your R-CHOP arm would perform differently from the one from Monjuvi phase III trial or the POLARIX phase III trial, at least in the IPI 3 to 5 group? That's the first question. The second one, just wondering for petosemtamab in frontline. Your trial design is chemo-free, so it's with pembrolizumab combo only, whereas [inaudible] is pembrolizumab plus chemo. Just wondering if you could elaborate a bit of rationale in that trial design to go without chemo, please. Thank you.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Xian. I think I'm going to pass them over again to you, Tahi.

Tahi Ahmadi
Chief Medical Officer at Genmab

Thank you. On the frontline diffuse large B-cell, I think first things first. I think it's best if we just stick to a few things first. We are very excited, and really much looking forward to this trial, based on everything we know about how EPKINLY has behaved in the past and how predictive these phase II data sets have been, not only in the second-line follicular lymphoma trial, but also now in the second, third-line diffuse large B-cell trial, in the combination with lenalidomide. The phase III trial is almost point to point replicated what had been described in the phase II data set. There's a lot of anticipation that we have, and I'm sure you too, for that trial. There's a lot of excitement about the results that are going to be then reported next quarter.

Tahi Ahmadi
Chief Medical Officer at Genmab

As it relates to the performance of R-CHOP, we have no visibility to how R-CHOP has behaved on that trial. We will find out when we get the data. I think it's probably fair to say that R-CHOP in the past, as you pointed out yourself, has had a very robust performance. It kind of behaves the way R-CHOP behaves across multiple trials. Generally speaking, cross-trial comparisons on the control arm are always a little bit flawed because they are informed by regions and patients and all of these things. We don't have really any visibility, but it's probably not unreasonable to assume that R-CHOP behaves like R-CHOP. On petosemtamab frontline, the question was what the reason was for the combination of pembrolizumab. A lot of these discussions happened a long time ago when this was still in the hands of Merus.

Tahi Ahmadi
Chief Medical Officer at Genmab

I think, generally speaking, head and neck patients are known to be a fragile population. Locality of the disease, status of the patient play a significant role in the tolerability of the treatment. Even today, if you look at the paradigm, there are patients who get treated with pembrolizumab chemo, and there are patients who get treated only with pembrolizumab. That is not only a decision made by the CPS score, but it's probably even larger informed by the patient that sits in front of the physician and their status. The data that is out there in the phase II for the combination for pembrolizumab, petosemtamab, though, is dramatically different. It's twice a high response rate and durability than has been described even for chemotherapy pembrolizumab.

Tahi Ahmadi
Chief Medical Officer at Genmab

In that regard, our anticipation is that petosemtamab and pembrolizumab is going to provide a truly very significant and important data set for patients with head and neck because it will have, hopefully, if it replicates the data in the phase II, a very significant OR and duration of response improvement even over chemotherapy combinations. We roughly range in the 30% range of response. We'll have a conversation about the comparison to what the JNJ strategy may or may not be when we have the data in our hands.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Tahi. I think very clear.

Xian Deng
Xian Deng
Analyst at UBS

Thank you.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Xian, for the questions. Let's move on to the next one.

Operator

Yes, of course. Now we're going to take our next question, and it comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Please ask your question.

Rajan Sharma
Rajan Sharma
Analyst at Goldman Sachs

Hi. Thanks for taking my questions. Firstly, just on EPKINLY and just on that first-line trial again. Maybe could you just help us understand, was the data that you saw in the second-line trial better than you were actually expecting internally? I'm just wondering if, maybe I'm stretching here, but is that giving you increased confidence that the frontline trial could read out at the interim? Could you maybe just discuss your latest perspectives on the endometrial cancer treatment landscape? Merck have said that they've hit PFS and OS from the interim of their TROP2-ADC trial. Does that, in your mind, when the data come, will that set a bar for Rina-S? Could you maybe just talk about areas of differentiation there and potential relative expression of TROP2 and folate receptor alpha in endometrial? Thank you.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Rajan, for the questions. Before Tahi starts, I think for the frontline study, I could tell you we are super excited based on the phase II studies, the data released last year at ASH, the year before at ASH, Rajan. We believe that this data will be very, very good in the frontline setting. Of course, the second-line data was also fantastic data, but it's unrelated, I feel, to the frontline data because it's in a different setting with different patients, with different levels of illness. I think we are excited about both settings. The frontline setting, I think the enthusiasm comes from rapid recruitment and also running against the gold standard. Our shop has been for over 20 years the gold standard in diffuse large B-cell lymphoma.

Jan Van de Winkel
President and CEO at Genmab

The phase II data actually show if that will translate to phase III, this will be sensational data. Let's hope for good data in the fourth quarter. Tahi, do you want to add anything to that? Then maybe Judith can go into the landscape for endometrial cancer.

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah, sure. The only thing I would add is I tried to make that point earlier. I think Jan touched on that. The len epco phase III actually reported out the way we were anticipating and hoping, and this is like a pattern that we've seen. The efficacy and safety of EPKINLY is very predictable. We have seen now multiple times that phase II combination data approximates very closely to what then the phase III describes in a larger data set, and this is also just to underscore the point that Jan was making. One of the reasons why we are continuously excited, looking forward to that data next quarter in the frontline, and then Judith can talk about the emerging, never changing, never stopping landscape in endometrial and anywhere else.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Tahi. Judith, are you back online? Apparently not, maybe Tahi, you can dive a bit into the endometrial cancer landscape.

Tahi Ahmadi
Chief Medical Officer at Genmab

I will do this very short. Look, yes, Merck has announced that they have hit the PFS on a TOP1-ADC with a TROP2 target. That has really very little bearing on our strategy because I think from the very beginning, we were aware that this was going to read out before the data sets for Rina-S are going to be available. We continue to be very excited about Rina-S, not only in PROC, where we already guided we're going to have some data this year, but also in endometrial. Folate receptor alpha is expressed maybe on a lower level than on PROC, but it is expressed. One of the things that we have routinely and repeatedly described with Rina-S is this phenomenon of efficacy across a spectrum of folate receptor alpha expression. Endometrial is an exciting second indication.

Tahi Ahmadi
Chief Medical Officer at Genmab

We initiated two phase III in that indication, we look very much forward to have that discussion when we have the data, I think there's not much more to say about this. We are executing our strategy and sticking to our plans.

Jan Van de Winkel
President and CEO at Genmab

Absolutely. We have a Breakthrough Therapy Designation, of course, in one of the settings in endometrial cancer. It's super important. Let's move on to the next question.

Operator

Yes, of course. Now we're going to take our next question. The question comes from the line of Eva Fortea-Verdejo. Your line is open. Please ask the question.

Analyst

Hi, team. Thanks for taking our question. On CRC, as the landscape becomes increasingly crowded with EGFR bispecific, how is your newly disclosed strategy differentiated from the competing assets in the space, particularly compared to amivantamab? If I might just sneak in a follow-up, given the growing focus on RAS-directed therapies in CRC, would a combination strategy with petosemtamab might be a viable approach? What's your current thinking on a potential development path for such a combination? Thanks so much.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Eva, for the questions. We like those questions because we are super excited about the potential differentiation of petosemtamab. I will ask Tahi to give you a bit more color on why we are so excited. We will present more data from the phase II setting in colorectal cancer at the-

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah.

Jan Van de Winkel
President and CEO at Genmab

At ESMO conference. Also the combinations is also an area we are pursuing. Tahi, why don't you give a bit more color to Eva?

Tahi Ahmadi
Chief Medical Officer at Genmab

Yes, please. Thank you. First things first, I think, colorectal as this new indication that we are embarking on with petosemtamab. If you recall, even when we start to talk about publicly the intended acquisition of Merus, there was already a lot of questions about colorectal. There was a relatively small data set that had been shared, but that numerically showed very impressive OR data. Of course, this data set has grown both in numbers of patients and durability, and Jan already pointed out that we will share that. Our enthusiasm has continuously remained very high for what we see in this data set and underscores our conviction that petosemtamab is not only the really in every data set, colorectal, head and neck monotherapy, combination, continuously to show that on point estimates and cost study comparisons are difficult.

Tahi Ahmadi
Chief Medical Officer at Genmab

It appears to have higher response rate and a better safety profile than, for example, amivantamab. This is what underscores the conviction that we really with petosemtamab have the best-in-class second-generation EGFR bispecific, and that will also translate into meaningful data sets in the phase III settings for both frontline and second-line colorectal, which is why we started these two trials now, even though, as you kind of like alluded to, JNJ already has started these trials. That's the colorectal part. The RAS field, of course, is super exciting. I worked on RAS inhibitor 12 years ago when it didn't work.

Tahi Ahmadi
Chief Medical Officer at Genmab

It's a super fascinating field to watch, we are obviously very aware of the importance of that biology and the novel drugs that are out there, particularly in colorectal, we are actively engaging in discussions to really embark on these novel combinations. There will be more to come in the near future.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Tahi. Thank you, Eva, again for pointing out this super exciting area, more to come this year, in the coming months. Let's move to the next question.

Operator

Yes, of course. Now we'll go and take our next question. The question comes then of Suzanne van Voorthuizen from Van Lanschot Kempen. Your line is open, please ask your question.

Suzanne van Voorthuizen
Analyst at Van Lanschot Kempen

Hi, this is Suzanne. Thanks for taking my questions. Also on petosemtamab, with your competitor or partner, J&J, going for accelerated approval with amivantamab in head and neck. Firstly, I wonder if and how this competitive development changed your filing or commercial strategy with petosemtamab at this point in time. Could you comment on that? Secondly, you mentioned a couple of times the high confidence in the best-in-class profile for petosemtamab compared to AMI. Could you elaborate on what is underpinning that confidence, the higher response, better safety in the datasets? What do you believe is driving that differentiation? Is it the molecule or the mechanism of action? Thank you.

Jan Van de Winkel
President and CEO at Genmab

Suzanne, thank you very much for these questions. I'm going to hand them over in a sec to Tahi, I can tell you that you'll definitely have to wait for the ESMO dataset for the phase II data, which will give you a bit of further color why we are so enthusiastic. As it relates to the strategy, we think that we will have a differentiated drug, actually, based on everything we know. I'll pause here and let Tahi give you a bit more color, Suzanne, on the head and neck setting and frontline, second line accelerated approval versus potentially approval based on phase III.

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah. Thank you. I'm going to reiterate what I tried to point out earlier. I think that if we step back on head and neck, where we are is we're going to have a top-line result in frontline in next quarter this year. Then AOS readout for the monotherapy in the first quarter of next year. I think this is completely different in terms of comprehensiveness, but also by capturing patient population profile than the accelerated profile now that J&J is pursuing with amivantamab in head and neck. We feel very comfortable, particularly because the larger population is in frontline. Our position where we are, and we're, of course, doing everything to accelerate these filings and these launches to the degree that is possible. Nothing changed on our end. We obviously did this, there's some partnership on amivantamab with J&J, some visibility to their plans.

Tahi Ahmadi
Chief Medical Officer at Genmab

This is exciting for patients, more opportunities. We are very confident in our head and neck strategy, and there will also be additional studies that we already announced that are going to be initiated in the very near future and may just not be public to discuss because I think we changed a little bit our strategy some time ago, similar to the colorectal trials, to publicly announce these trials more closer to when the first patient is dosed. Your second question was around what again, sorry?

Jan Van de Winkel
President and CEO at Genmab

Best-in-class criteria. Why do we say that?

Tahi Ahmadi
Chief Medical Officer at Genmab

Why do we say this? Why do we say this? Cross-study comparisons are difficult, but if you just cross-compare monotherapy in second-line head and neck, the small dataset that were presented in combination with pembrolizumab in frontline for both trials, for both drugs. The colorectal combination with chemotherapy datasets that exist for both drugs. In all four of these datasets, actually, petosemtamab outperforms amivantamab on the efficacy. In totality, it does have a differentiated safety profile. It doesn't have the same challenges, to the degree, at least, with skin-related toxicities. I think it's a little bit speculative to figure out why that is, but they're clearly different antibodies with different secondary arms. It's not unreasonable to speculate that the difference in the second arm may have a biological mechanistic role that differentiates both on efficacy and safety.

Tahi Ahmadi
Chief Medical Officer at Genmab

As is, and I think there's now a larger dataset, I think all indicators are that it is slightly differentiated on efficacy and actually reasonably differentiated on safety. This is where we come with this conviction that we have a best-in-class asset in our hand.

Jan Van de Winkel
President and CEO at Genmab

Thank you, Tahi. Thanks, Suzanne, for the questions. Let's move on.

Operator

Thank you. Now we're going to take our next question. Now we're taking the question from Charlie Haywood from Bank of America. Your line is open, please ask your question.

Charlie Haywood
Charlie Haywood
Analyst at Bank of America

Hey, Charlie Haywood, Bank of America. Thanks for taking my questions. I have two, please. This first one is just, well, both actually, on Rina-S. First is on the second-line progression-free survival data you've got coming in fourth quarter. Both phase II, phase III in fourth quarter. Could you just remind on any differences to consider between the trials in terms of recruitment, patient cohorts, anything to consider as we sort of read across between the two? Secondly, we've seen limited phase II PFS data for the folate receptor class in general. Could you frame any target PFS profile or PFS delta versus control arm you'd expect to see to be clinically meaningful for that phase III readout? Thank you.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Charlie, for the questions. Tahi, can you address both of them, differences between the phase II and phase III, and then the profile as it relates to folate receptor alpha expression levels?

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah. By inclusion, exclusion criteria, they're very much more or less the same patient population. There is a readout for sure based on the phase II data to the phase III data, the only difference is, of course, a phase II data set has always its own dynamics, vis-a-vis a phase III trial. There's obviously a larger footprint for a phase III trial as it relates to a phase II trial. These are the where the patients come on and the difference between having a choice or being forced to have a choice versus not having a choice. That's the difference between these two data sets, probably all to say to that. As it relates to speculating on the readout, I don't think I want to do that.

Tahi Ahmadi
Chief Medical Officer at Genmab

All I can say is that we are super excited about this data, that if you look at what is already in the public domain for Rina-S, it shows a very high response rate, 50%+, which is probably even more important, a very long durability of response. This duration of response is driven by a safety profile with a very low single-digit discontinuation rate due to AE, it then allows a long continuation of treatment, which then drives the duration of response. If you put these things together, you can already get a sense of the direction of the PFS, which I think will be without a doubt not only significant but also meaningful for patients. I think that's where we should leave it, then we can have this conversation when the data is in the public domain.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Tahi. On top of that, Charlie, you will get that we are like a year, one and a half years ahead of some of the potential competitors. I think we're in good shape here.

Charlie Haywood
Charlie Haywood
Analyst at Bank of America

Thank you.

Jan Van de Winkel
President and CEO at Genmab

Thanks. Thanks, Charlie. Let's move on to the next question, operator.

Operator

Yes, of course. Now we're going to take our next question. This question comes to line of Yaron Werber from TD Securities. Your line is open, please ask your question.

Yaron Werber
Yaron Werber
Analyst at TD Securities

Great. Thank you so much. Quick question on petosemtamab. For the first-line study, can you just give us a sense when you upsized this study, can you confirm that you didn't change the powering assumption, and that you're enrolling the random distribution of HPV negative and positives that are in the market, you're not enriching specifically for only one subtype? Secondly, you're going to show us the second-line recurrent head and neck data at ESMO with or without pembrolizumab. Is there a chance that you might want to move to phase III in that study with pembrolizumab to complement your monotherapy second-line data, which is coming Q1 next year? Thank you.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Yaron. Tahi, can you address both of the questions?

Tahi Ahmadi
Chief Medical Officer at Genmab

Let's take the first one first. This is I think we said multiple times we changed this trial to increase the probability of success, and this was not in any particular shape or form driven by anything that really emerged after the acquisition. This was actually a decision that we at Genmab had made during the diligence process, and that got executed immediately. It was one of the first things that we actually executed, and this was purely driven to ensure that we have the proper power for all kinds of subgroup analyses that are going to be important for global filings. I think that's all there is to say about this. The rest is not necessarily part of our thought process or anything that we have spoken about.

Tahi Ahmadi
Chief Medical Officer at Genmab

The second question that you had was around other strategies for petosemtamab, and I would say this, we've been very clear there's going to be more to come on petosemtamab and head and neck. We will present these trials in the granularity and at a time similar to what we just did with colorectal when they are literally dosing patients. That is so in some near future, we'll have more conversation about more activities or what trials in head and neck, if that's fair.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Tahi. I think that's clear. Thanks, Yaron, for the questions.

Operator

Yes, of course. Now we're going to take our next question. The question comes line of Ben Jackson. Your line is open. Please ask the question.

Analyst

Brilliant. Thank you for the question. I've got two, please. The first one on Rina-S. We've seen a couple of other companies make moves into drugs that look to overcome TOP1 resistance. The aim for Rina-S is to come first to market, but are there any implications to this, and thinking positively or negative how this resistance could emerge for when thinking about the Rina-S commercial opportunity once the competition comes to market? Secondly, not a focus topic today, lots of other stuff going on, but obviously any updated thoughts on the EpCAM potential in I&I diseases where B-cell pathology is key. There's obviously a few competitors making noises in this area with similar drugs. It'd be interesting to hear your thoughts there. Thank you.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Ben, for the question. With Rina-S, we of course hope to be first to the market and we are going to read out already a phase III in Q4. Tahi, do you want to comment on TOP1 resistance and strategy for Rina-S?

Tahi Ahmadi
Chief Medical Officer at Genmab

Well, I mean, you said the 1st one, the most important part is there are already three phase IIIs actively enrolling patients in ovarian cancer. One in PARP and two in PSOC, one maintenance and one in the platinum replacement strategy. We are constantly and actively working on moving essentially the entry point for Rina-S into earlier lines. We have already talked about that there's more to come also in the ovarian cancer space with Rina-S. That's basically the reality. You have to develop these drugs, just try to move into earlier lines as efficiently and as effectively as data allows and operation allows.

Tahi Ahmadi
Chief Medical Officer at Genmab

That's the first, partly also the only thing to say about this emerging idea of TOPO resistance, because if Rina-S, which we have very confidence will be the 1st TOPO payload ADC in PARP, this is more a post-Rina-S problem, to be honest.

Jan Van de Winkel
President and CEO at Genmab

Exactly. I&I and epcoritamab, right now the focus is on cancer, multiple cancers, and we will have exciting data readout in Q4. Let's discuss I&I in more detail in the future. Cancer is clearly the priority for us by now. Operator, can we move to the next question?

Operator

Yes, of course. Now we're going to take our next question. The question comes line of Judah Frommer from Morgan Stanley. Your line is open. Please ask the question.

Judah Frommer
Judah Frommer
Analyst at Morgan Stanley

Hi, thanks for taking the question. Maybe just a follow-up on petosemtamab in frontline. Can you help us with thoughts on the nature of the update in Q4? It'll be a top line, can you give us any direction on whether you'll press release in line with some of the top lines we've seen for EPKINLY, or could we potentially see subgroup data perhaps by HPV status? If not, do you have a sense for when we would see responses by HPV negative versus positive patients? Thanks.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Judah. Tahi, can you give a bit of color on the top line results that we intend to present in the Q4 timeframe?

Tahi Ahmadi
Chief Medical Officer at Genmab

Well, I think the accurate response to that question is top-line results in Genmab historically focus on the primary endpoint. I think that's what's going to be happening for petosemtamab as well. Then, obviously once we have the top-line results, we can also communicate when we expect to have a more granular discussion of the nuances of the data in a public presentation at a conference.

Jan Van de Winkel
President and CEO at Genmab

Thanks. Thanks, Tahi. I think we keep it to that, Judah, this time.

Operator

Thank you. Now we're going to take another question. Now the question comes to line of Victor Floc'h from BNP Paribas. Your line is open. Please ask your question.

Victor Floc'h
Victor Floc'h
Analyst at BNP Paribas

Hi. Thanks so much for taking my questions. Actually two questions on EPKINLY. First one, very impressive momentum lately, obviously you've mentioned the accelerated uptake in the community setting. Just from a modeling perspective, is there any stocking we should be aware of when it comes to modeling the remainder of the year for EPKINLY? My second question, still on EPKINLY, but on IP. There is a report from Bloomberg arguing that EPKINLY's formulation patent family could extend beyond the combination of matter patents and could potentially add five years, potentially in the U.S., six years in Europe. Just wondering whether you can discuss your IP strategy and your current assumption for EPKINLY in terms of IP. Thanks so much.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Victor, for the questions. The first one can be handled by Brad, the second one, I think I will ask Tahi to give some color on the length of time for the patents. Brad, why don't you start on the stocking question?

Brad Bailey
CCO at Genmab

Yeah, no, thank you for the question. Just briefly on the community, we are encouraged, as you mentioned, with the momentum there, it's due to the dual indications, the only bispecific with the dual indications, and it's really been received extremely well by physicians as well as health systems. As it relates specifically to stocking, no stocking issue or no stocking at this point in time to be discussed.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Brad. Tahi, do you want to add to address the IP and the length of time we have patent protection, or don't you want to do that right now?

Tahi Ahmadi
Chief Medical Officer at Genmab

Yeah, I would say this, discussing our patent and IP strategy on calls like this in the nuance details is probably not appropriate. Right now, I would stick to mid-30s is where we are. Then, of course, there's always an IP strategy to try to generate additional intellectual protection, property protection that helpfully extends some of that protection.

Jan Van de Winkel
President and CEO at Genmab

Okay, thanks, Tahi. I think, Victor, we keep it to that for now.

Victor Floc'h
Victor Floc'h
Analyst at BNP Paribas

Great. Thank you very much.

Jan Van de Winkel
President and CEO at Genmab

Thanks.

Operator

Thank you.

Jan Van de Winkel
President and CEO at Genmab

Any further questions?

Operator

We have. Would you like to take?

Jan Van de Winkel
President and CEO at Genmab

Yes. Why don't we take one or two more, and then we probably have to end the call and follow it up one-on-one.

Operator

Yes, of course. Of course, not a problem. Now we're going to take our next question then. The question comes from line of Kalpit Patel. Your line is open. Please ask your question.

Analyst

Yeah, hey, thanks for taking the question. One more on the first-line DLBCL study. I guess originally when you guys designed that protocol and had assumptions for that frontline study Is the timing of the readout fourth quarter more so in line with what you guys originally modeled when you first started the study? Then when you completed the enrollment, I believe in 2024, did that estimate, the timing estimate of the readout materially shift? The reason I ask is because, the start to finish still looks roughly in line between when frontline and the POLARIX study started and they finished. Any color on your model assumptions would be useful. Thank you.

Jan Van de Winkel
President and CEO at Genmab

Look, Kalpit, we are super excited about the frontline setting. The readout will be in Q4. We believe that the data will be excellent based on the phase II data. We're not going to address any further timing and timeline issues here. Look forward to the data.

Operator

Thank you. Now we're going to take our final question for today. Just give us a moment. The question comes line of Matthew Phipps from William Blair. Your line is open. Please ask your question.

Matthew Phipps
Matthew Phipps
Analyst at William Blair

Hi, thanks for squeezing me in. Comparing the frontline CRC trial with peto to the OrigAMI-2 trial, they obviously look pretty similar in design, except for the peto trial does include an ORR primary endpoint. Is this safe to assume you will try to explore Project FrontRunner in that frontline trial? Then just curious on Rina-S in non-small cell lung cancer. They've had a trial ongoing there this year. Any updated thoughts on the potential there or when we might see some data from that phase II trial? Thank you.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Matt, for the questions. Tahi, can you address both for the frontline CRC trial and also the non-small cell lung cancer trial data for Rina-S?

Tahi Ahmadi
Chief Medical Officer at Genmab

It is fair to assume that we will also explore, if it is opportune, Project FrontRunner opportunities for colorectal for both trials. I think that is a fair assumption. On the lung cancer Rina-S trial, once we have a data set that allows a robust discussion on what the next steps are going to be, I think it is a proper and opportune time to present that data. I have said this many times, we are working in a super competitive environment. There are multiple folate receptor ADCs from very large competitors that are coming left and right. I think presenting data without having already actions on it may not necessarily be the smartest thing for us to do. We will present that data at the time when we also have the next steps ready.

Jan Van de Winkel
President and CEO at Genmab

Thanks, Tahi. Thanks, Matt. Thank you all for joining us today, and thank you for that lively and invigorating Q&A. With three super important phase III studies reading out in the coming months, we are well on track to deliver sustainable growth well into the next decades. We look forward to sharing some more exciting updates with you in the future as we move through the rest of the year. As always, if you have questions for now, please reach out to our IR team.

Operator

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

Tahi Ahmadi
Chief Medical Officer at Genmab

Thank you

Analysts
    • Jan Van de Winkel
      President and CEO at Genmab
    • Tahi Ahmadi
      Chief Medical Officer at Genmab
    • Brad Bailey
      CCO at Genmab
    • Anthony Pagano
      CFO at Genmab
    • Zain Ebrahim
      Analyst at JPMorgan
    • Michael Schmidt
      Analyst at Guggenheim Partners
    • James Gordon
      Analyst at Barclays
    • Analyst at Truist
    • Xian Deng
      Analyst at UBS
    • Rajan Sharma
      Analyst at Goldman Sachs
    • Analyst
    • Suzanne van Voorthuizen
      Analyst at Van Lanschot Kempen
    • Charlie Haywood
      Analyst at Bank of America
    • Yaron Werber
      Analyst at TD Securities
    • Analyst
    • Judah Frommer
      Analyst at Morgan Stanley
    • Victor Floc'h
      Analyst at BNP Paribas
    • Analyst
    • Matthew Phipps
      Analyst at William Blair
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