Hello, and welcome to the joint MorphoSys and Incyte Conference Call and Webcast to discuss the FDA approval of MONJUVI. At this time, all participants are in listen-only mode. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to introduce Anja Pommrén, Head of Investor Relations for MorphoSys. Please go ahead, Anja.
Thank you. Ladies and gentlemen, good afternoon or good morning. My name is Anja Pommrén, and I'm the Head of IR at MorphoSys. It is my pleasure to welcome you to this joint MorphoSys and Incyte Conference Call and Webcast to discuss the FDA approval of MONJUVI. We have speakers from both Incyte and MorphoSys on today's call. From MorphoSys, we have Jean-Paul Kress, CEO, Malte Peters, Chief Research and Development Officer, and Roland Wandler, Chief Operating Officer. Speakers from Incyte will be CEO Hervé Hoppenot and General Manager North America, Barry Flanagan. Also joining for the Q&A session will be Steven Stein, Incyte's CMO, and Christiana Stamoulis, Incyte's CFO, as well as Jens Holstein, MorphoSys' CFO. Michael Booth, Head of IR of Incyte, will conduct the Q&A session together with me.
During the question and answer session, we kindly ask you to limit yourself to one question, and if needed, one follow-up, as this will enable as many of you to ask questions as time allows. Before we begin, I'd like to remind you that some of the statements made by Incyte and MorphoSys during the call today are forward-looking statements, including statements regarding our expectations for the commercialization of our products and our development plans and expectations for the compounds in our pipeline, as well as the development plans of our collaboration partners. These forward-looking statements are subject to a number of risks and uncertainties and may cause our actual results to differ materially, including those described in Incyte's 10-K, MorphoSys' 20-F and annual report, all for the year ended December 31st, 2019, and from time to time in other SEC documents of Incyte and MorphoSys.
In addition, I would like to caution everyone that the COVID-19 pandemic is an evolving situation, and it is still relatively early to be able to assess the full effects of governmental, business, and social actions and policies and overall economic conditions on our business. Accordingly, it is important to keep in mind that our statements on this webcast speak as of today. I now hand over to Jean-Paul.
Thank you, Anja. Good morning or good afternoon, everyone. We are all very proud that last Friday, MONJUVI received FDA approval as a combination therapy with lenalidomide. The approval provides a new important treatment for adult patients with DLBCL who have progressed after treatment with first-line therapies or later lines of treatment, or whose disease has relapsed and who are not eligible for autologous stem cell transplant. This approval is a very important milestone, not only for MorphoSys and Incyte, but also for the patients battling relapsed or refractory diffuse large B-cell lymphoma. We are very excited with the accelerated approval of MONJUVI by the FDA, which we believe emphasizes the high unmet need for patients with relapsed or refractory DLBCL. We have a fantastic opportunity with MONJUVI in combination with lenalidomide, as it is the first FDA-approved second-line therapy for adult patients with RR-DLBCL.
Over the past month and weeks, both our teams from MorphoSys and Incyte have been working hard to ensure a very well-prepared and successful launch, and thus, to be able to bring this important treatment to market in the U.S. For MorphoSys, the approval of MONJUVI not only marks an important transformational step into an integrated biopharmaceutical company, but also highlights significant progress for all our stakeholders. MorphoSys is committed to developing innovative biopharmaceuticals designed to improve the lives of patients with serious diseases. I also want to take the opportunity to thank all my colleagues at MorphoSys who have worked diligently to successfully develop MONJUVI and to acknowledge the ongoing efforts of the FDA to bring new products to cancer patients. I want to thank all investigators, patients, and their families, as well as caregivers, without whom clinical development is not possible.
Before I hand over to Hervé, I want to highlight that we are also delighted to have achieved this success together with our partner, Incyte. I am convinced that MorphoSys and Incyte will continue to work together as we execute the joint commercialization of MONJUVI in the U.S. Hervé, please.
Thank you, Jean-Paul. Obviously, I agree that we have a very exciting opportunity here to change the standard of care in second-line treatment of DLBCL. In the months since we signed the collaboration in January, tafasitamab received priority review for the BLA in February, and we shared exciting new ELMieNE data at the recent EHA Congress. The approval of MONJUVI in the U.S. is important for MorphoSys and Incyte, but it's only the first step of an ambitious program. We recently announced the submission of MONJUVI for the same indication of relapsed refractory DLBCL in Europe, and if review is positive, this could lead to an approval in 2021. In addition, we have ongoing plans to continue to develop tafasitamab in DLBCL and in other B-cell malignancies.
The phase III BEAMIND trial, tafa plus bendamustine versus rituximab plus bendamustine, is already underway in patients with relapsed or refractory DLBCL, and we expect to initiate a pivotal program in first-line DLBCL early next year. For multiple B-cell malignancies, the plan to develop tafa in combination with parsaclisib, Incyte's PI3Kδ inhibitor, is also on track, and we expect to start that study before the end of 2020. I will pass to Malte to walk you through the clinical aspect of Friday's announcement.
Thank you, Hervé. First of all, I want to thank the FDA for the support during the review of the BLA for MONJUVI in combination with lenalidomide. During the approval process, our dialogue and exchange with the FDA was always very constructive and helpful. The approval now provides a new treatment option for patients with relapsed or refractory DLBCL. DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide. Approximately one in three patients initially diagnosed with this aggressive disease either do not respond to or relapse after treatment with the current standard of care, R-CHOP. R-CHOP is a combination treatment of rituximab and chemotherapy. Patients with relapsed or refractory DLBCL who are not eligible for stem cell transplant are poorly served by the current treatment options. Prior to the approval of MONJUVI, there was no FDA-approved second-line therapy to treat patients with relapsed refractory DLBCL.
The unmet need is therefore apparent. MONJUVI was granted accelerated approval under priority review with a Breakthrough Therapy designation based on the phase II L-MIND study, an open-label, multicenter, single-arm trial, which tested MONJUVI in combination with lenalidomide. Following FDA's approval in the U.S., MONJUVI in combination with lenalidomide is now indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, not otherwise specified, including DLBCL arising from low-grade lymphoma and who are not eligible for autologous stem cell transplant. The clinical data in the FDA prescribing information show that in the L-MIND study, MONJUVI in combination with lenalidomide shows a noticeable objective response rate, a high complete response rate, and a long duration of response. Subsequent analysis with longer observation times, as recently shown at the EHA conference, confirmed the durability of response.
Moreover, importantly, MONJUVI was well-tolerated in the ELMieNE trial, providing an important treatment option, particularly for patients who are not eligible for or cannot tolerate other forms of treatment. With this, I would now like to hand over to the commercial team, starting with Roland.
Thank you, Malte. Let me start by extending a heartfelt thank you to the patients, investigators, caregivers, and advocacy organizations, and to MorphoSys and Incyte colleagues around the world who helped us throughout our journey so far. We have a remarkable opportunity with MONJUVI, and we at MorphoSys and Incyte are excited and well prepared to bring this treatment to patients in the United States. Our teams anticipated and prepared for an early FDA approval and have been laser-focused on executing a strong MONJUVI U.S. launch strategy. We estimate that there are approximately 10,000 new patients with relapse or refractory DLBCL each year in the U.S. that will be eligible for MONJUVI in second or later lines of therapy. Many of these patients have poor prognosis, and this means our work to launch MONJUVI cannot wait.
MONJUVI is the first FDA-approved therapy for adult patients with second-line DLBCL in combination with lenalidomide. It offers noticeable clinical efficacy data and sound safety and tolerability. We are excited to bring this much-needed therapy to patients. We have worked very closely with our colleagues at Incyte over these past months to lay the foundation for a successful launch through building a strong commercial organization, appropriately interacting with healthcare providers, and preparing for patient access. Over the last several months, we are pleased that our medical teams have conducted extensive outreach to relevant healthcare professionals. The overall feedback received from these discussions with physicians and lymphoma experts is that MONJUVI provides a unique value proposition to meet a continuing unmet need in relapsed or refractory DLBCL. Our commercial organizations are trained and ready.
At MorphoSys, we have been fortunate to hire some of the best oncology sales talent in the industry, and our team members have a long track record of deep customer experience and marketplace knowledge within the hematology oncology space. They are now moving to engage healthcare professionals in the U.S. about MONJUVI. For this, during this COVID-19 period, we are using a combination of virtual engagement tools to address customer needs and to initiate, maintain, and grow connectivity with healthcare providers. We are reaching out to payers starting today to share information on the approval, and we expect coverage will be in line with the labeled indication with access to MONJUVI on the government programs, including Medicare Part B, as well as by commercial insurers in the U.S.
We are moving MONJUVI through the last steps of our supply chain, and it will be available through our already established specialty distributor and specialty pharmacy network. As to pricing, we sought to thoughtfully price MONJUVI by balancing the value of the outcomes and innovation it brings to patients and the healthcare system with market and societal expectations. The wholesale acquisition cost will average $16,500 per month for the first year of therapy, followed by an average of $13,000 per month in subsequent years as a result of a decrease in the required number of doses per cycle. MorphoSys and Incyte are also dedicated to supporting patients throughout their treatment journeys, and we are committed to help lower patient access barriers. As part of this commitment, we have launched a ROBUST patient support program called My MISSION Support.
This program offers financial assistance, ongoing education, and other resources to eligible patients who are prescribed MONJUVI in the U.S. At this point, I want to turn the call to our partner, Incyte, whose expertise and established presence in the hematology oncology field will be a key part of the commercial success of MONJUVI. Barry, please.
Thank you, Roland. It's a pleasure to be speaking with you today and to share our excitement for the launch of MONJUVI in the United States. Our commercial and medical teams are well-prepared for the launch, and we expect MONJUVI to be available commercially shortly. We know from our interactions with hematologists and oncologists that MONJUVI represents an important addition to the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma because their prognosis can be very poor. Driving awareness, education of healthcare professionals and patients, and providing patient access to MONJUVI are the key components to a successful launch, and we, along with our colleagues at MorphoSys, are ready. The collaboration has been fruitful over the past several months, and even with restrictions placed on us because of COVID-19, we are fully prepared for the launch.
Incyte and MorphoSys will run largely mirrored commercial and medical teams throughout the U.S. to support MONJUVI. Both teams are aligned on our priorities. We will be focused on approximately 11,000 key prescribers across the U.S. There is an approximately 80% overlap with JAKAFI in this group. Our relationships are already strong. The field teams for MONJUVI include both medical and commercial from both MorphoSys and Incyte. They will be equal to approximately 150 people. We believe that's the right size for the target audience. Our ability to leverage Incyte's existing relationships and experience with hematology oncology is also very important. Perhaps especially so in a mostly virtual environment during a time of COVID-19.
We have spent years working with healthcare professionals, and we have built trust through developing best-in-class or first-in-class assets, excellent customer service, educational resources, and patient assistance programs as we strive to help improve patients' lives. Our recent launch of PEMAZYRE and continued success with JAKAFI are good examples of our ability to thrive in a more virtual environment, and we plan to leverage our expertise in multi-channel engagements and other technologies as we seek to drive increased awareness of MONJUVI. With the team at MorphoSys, we also plan to host an event for investors and analysts later this year. During this event, which we expect to include expert guests in the field of DLBCL, we intend to share further thoughts on global development plans for tafasitamab and to provide you with an update of our joint U.S. commercialization activities.
The teams at Incyte and MorphoSys have much to achieve over the coming weeks and months as we launch MONJUVI, but we are excited by the challenge and by the opportunity to bring another novel therapy to patients in need. With that, I'll turn the call back to Anja.
Thank you, gentlemen, for taking us through the details of the FDA approval of MONJUVI and the preparation work for its launch in the U.S. Operator, are we now ready to take the questions now?
Thank you. We'll now be conducting a question and answer session. If you'd like to be placed into the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment please, while we poll for questions. Our first question today is coming from Marc Frahm from Cowen and Company. Your line is now live.
Hi, thanks for taking my questions and congratulations on the approval. In the prepared remarks, you mentioned the label being a bit earlier line than many of the other things that have been approved recently in RR-DLBCL. About how many of those 10,000 new patients per year that you think are eligible for MONJUVI, do you think are not eligible given the labels that your competitors have?
Do you want to take that question?
Malte taking the question, yeah.
I think the 10,000 patients that we refer to are based on our assumption of the second-line and higher label. We believe that the 10,000 patient would provide the patient pool per year or the number of patients per year that would be eligible for the treatment of MONJUVI and lenalidomide. That's based on our current assumption, and we would believe that the full amount of 10,000 patients would benefit, hopefully, from the treatment of our combination therapy.
I guess, when you analyze the market, is competitors like Polivy or CAR T-cells that are kind of approved in the third line or later, do you guys think all 10,000 are eligible for those therapies, or is it only a much smaller number that is eligible for those, five or six thousand?
This is Jean-Paul Kress, I'll jump in here. We actually plan to give you a better view on these numbers in our upcoming event in the fall. However, obviously it will be about market share and how fast we'll be able to do with our uptake in COVID times. In broad terms, you could assume that 10,000 patient is covered by the label, but obviously there will be possibilities of market share versus the other products. Obviously, we think we're very well positioned versus Polivy, as you can imagine, with having the first and only second-line treatment on the market now. The efficacy, the safety, and the very manageable aspect of administration of the product makes it a very compelling proposition for our target.
Marc, hi, it's Steven from Incyte. Just to try add maybe a little bit of color. If you step right back and you look at the incidence of diffuse large B-cell lymphoma in the U.S. to begin with, you're dealing with about 25,000 new patients a year. If you take the first-line standard of care chemotherapy combination with a CD20 antibody or CHOP, and you assume that occurs approximately half of patients, you end up with about 12,500 patients. Then you take that patient set and you see who then in that line of therapy would be eligible again for potentially curative therapy with another high-dose chemotherapy regimen in the second line and a stem cell transplant, and you eliminate a few thousand patients then. Then you're right within the label at that point.
You're in relapse/refractory diffuse large B-cell lymphoma, not eligible for transplant, and you'll end up then with about 10,000 patient, new patient incidents. That's how we get to that number. This is the only labeled indication now in the United States for second-line therapy. Polivy and CAR T-therapies are labeled for third-line therapy and are somewhat different population pool. That's how we estimate or guesstimate that 10,000 number. I hope that's a bit clearer.
Okay. That's helpful. Thank you.
Thank you. Our next question today is coming from Graig Suvannavejh from Goldman Sachs. Your line is now live.
Craig, good morning and good afternoon. Congratulations on the early approval. I just had maybe two questions. First, can you give us a sense of, and maybe it's premature, but I'd love to get your thoughts on what your expectations are for the shape of the launch curve. Obviously getting a second-line label where there is no FDA-approved second-line treatment is a great thing for MONJUVI, but I was wondering if you're expecting, whether it's based on the timing of when you'll be able to secure reimbursement, whether you think this is going to be kind of like a more gradual launch, or are you expecting that given that there's nothing out there that potentially this could be a very quick uptake. That's my first question. My second question, if I could is, I'm wondering how you think of the competitive landscape in the future.
I do believe Roche is running the POLARIX study, which is a phase III study for which potential first-line use could come in early 2021. I'm just wondering if you have any thoughts around what do you think that data might look like, and how that might impact the shape of the launch curve for MONJUVI? Thank you.
Thanks, Graig. This is Jean-Paul. Thanks for your question. I'll take the first part of the question. Malte will address the second one on the first line. Regarding the long shape take, obviously, as mentioned earlier by Steven and Malte, we have a very compelling label. Very confident in the longer-term potential of the product and, potentially, the leadership aspect of what we can achieve here. Obviously, we are in a COVID-19 era. We have to be cognizant of what it means for the space, for the patients, for the HCP, and on that, we have to be a bit reasonable here in terms of uptake. It might be slower than what we could usually expect. Malte, on the first line?
Yeah, on the first-line study, your correction stating that POLARIX data is reading out in 2021. I would not like to give an estimate of what the probability of successes of this study. Of course, we're monitoring the situation very clear. Our label, which is in second-line and higher patient, and our forecasts are, in our mind, not affected by how the outcome of the POLARIX study will be. Of note, and Hervé has alluded already to this, we are very pleased on the progress we are making in our own frontline studies. Our first-line study is rolling ahead of our expectations, and we plan to initiate our pivotal first-line study at the beginning of next year.
Great. If I could just have one quick follow-up just on the comments you made about the teams. They'll be separate teams, they'll be, I guess, mirroring each other. Could you maybe give a little bit more clarity on how the separate teams will work? I'm just maybe trying to better understand if there Are all the marketing materials and the branding, will they all be the same, or will there be duplicative but separate efforts depending on how each of the companies believes MONJUVI should be best marketed? Thanks.
Well, Graig, I'll start.
Hold on. I'll cover this one. Barry, yeah.
I'll start, and I'm sure Roland will fill in. There's approximately 57 territories that are mirrored, one Incyte representative, one MorphoSys representative, and they obviously work together and are planned to go around the territories separately at different times, be in different parts of the territory, for example. As far as the promotional materials, they're all exactly the same. We work together. We have a team that is from Incyte and MorphoSys, all of the promotional materials, education materials will be the same.
Okay. Helpful. Thank you very much. Congrats again.
Thank you. Our next question today is coming from Tyler Van Buren from Piper Sandler. Your line is now live.
Hey, guys. Good morning, good afternoon, and congrats on the approval. Can you just discuss perhaps any interactions with the EMA and your confidence in approval in Europe? I guess there's a thought out there that the EMA is taking a stronger stance on uncontrolled studies in areas where there are active competitors, or comparators, sorry. Just any thoughts on being able to use the L-MIND data for potential approval there. Thanks.
Tyler, thanks. It's Steven from Incyte. I'll start off. Malte may want to add something. We're encouraged thus far. We've put the submission in, and we've announced that it's been validated by the European Medicines Agency. The content therein is reviewable. You're right in the sense, across the board, that single-arm studies traditionally have been harder to get approval there. Again, as we've been pointing out on this call, this is a large unmet medical need here. It's not a curative setting once you're in relapsed/refractory diffuse large B-cell lymphoma that's not eligible for transplantation. There are differences in labels of some of the competitor drugs in Europe, which may end up impacting the review cycle.
We'll use all the data that's available to us that MorphoSys have been generating over the years to try and convince the regulators, and we remain encouraged by what's developed thus far.
Would it be possible just to elaborate on the differences in the labels that could impact the review cycle?
I think the obvious ones are lines of therapy. If you look, for example, Polivy as a second-line label there. There's some use differences in terms of availability and accessibility of CAR T therapies that may impact some of the regulatory thinking in Europe, but nothing beyond that at the moment.
Okay. That's very helpful. Thank you.
Steven, just a quick addition from my end. You were completely right, fully supportive of what you said. The reaction so far we received from EMA was throughout very encouraging. With respect to the approvability of an uncontrolled study, remember, the CAR T cells had also uncontrolled studies, also achieved an approval in Europe. Based on the high unmet medical need, as Steven pointed out, we are quite optimistic that EMA will look at our data in a very positive way.
Thank you. Our next question today is coming from Jason Butler from JMP Securities. Your line is now live.
Hi. Thanks for taking the question, and let me add my congrats. Just wondering if you could give us some more color on strategies for confirmatory studies. Thinking about the BMIND study, which is obviously a different combination, or the frontMIND study or other studies that you might be considering that could support full approval. Thank you.
Thanks for the question, Jason. This is Jean-Paul. The FDA has been very constructive and supportive in the discussions regarding confirmatory trial options. They actually have agreed on focusing on the synergy of tafas plus lenalidomide, which is very important. As a result, we align with FDA on using our first-line pivotal trial as a confirmatory trial with a final report submission by the end of 2025. As Malte commented earlier, we've made great progress with them on the first-line design, and details we'll share with you later in the fall. This is actually a very good outcome. Very pleased with what we align on with the FDA for our confirmatory trial here.
Great. Just a quick follow-up on your pricing assumptions, specifically around weight. Was the average assumption driven by the baseline characteristic in L-MIND and any reason that these assumptions could be different in the real-world setting? Thanks.
Maybe on the pricing, I'll ask Roland to comment.
Yes. Jason, you're right. We have weight-based pricing, and our assumption for the average patient here was for a patient with 70- 80 kilograms per weight, which would translate into five vials per infusion. This is reflective not only of what we've seen in the trial but also what we see in the general population out there for these patients with lymphoma.
Great. Thanks for taking questions, congrats again.
Thanks, Jason.
Our next question today is coming from Brian Abrahams from RBC Capital Markets. Your line is now live.
Hi. Good morning and good afternoon, and congrats on the approval. Some of the feedback we've received in the past is that real-world patients with refractory DLBCL can be tougher to treat than in the clinical trial setting. I'm curious to hear about your approaches to ensuring that physicians select patients appropriately to optimize MONJUVI's use and outcomes. I'm curious to what degree the safety and longer duration of use might improve the translatability for this drug between the trial setting and real-world outcomes. Is there any education you might need to do about preservation of the CAR T option? Thanks.
Hi, Brian, it's Steven Stein. I'll lead off again. Malte may want to add to my comments. Obviously, when you conduct a clinical trial, you have inclusion and exclusion criteria that impact patients' eligibility. In fact, one of the main thinking we always undergo is to try and replicate as much as possible what does occur in the real world. In terms of tougher to treat, it's a little hard to comment on what you're saying, but I think our clinical trial will, for the most part, replicate what should occur in the real world. Obviously, physicians weigh risk-benefit to everything they do. Efficacy first, and you've heard and you've seen our label now in terms of the efficacy data and the second-line label with the 55% response rate, 37% CR rate and 21.7-month duration of response data.
They'll weigh that in, they'll look at the tolerability profile as well, which we find very encouraging compared to competitors in terms of some other side effects seen like cytokine release syndrome with CAR Ts and some other side effects with some of the other therapies. They'll weigh that into their therapy choices every single time. We think that'll dictate the treatment course. The durability data we find very encouraging, not in the label but in the EHA presentation. You saw updated data with longer follow-up that we also find very encouraging in terms of picking patients for appropriate therapy. In terms of the back part of your question, I think you're alluding to biology. Does giving CD19-directed therapy change what you can then use as therapy thereafter?
We have, and MorphoSys have produced in a very elegant way in CLL thus far, looking at is the receptor retained after therapy, and it's been illustrated that it is in that particular setting, and we'll obviously have to generate more data in diffuse large B-cell lymphoma, et cetera, to just make sure that that is indeed the case. That then you can use, for example, CD19-directed CAR T therapies after giving tafas. That'll be all important in therapy choices. We think our positioning with the efficacy data, our tolerability profile, and in terms of the biology, in terms of looking like the receptor's retained, it does position the therapy really well at the moment. I don't know if Malte wants to add anything.
No, Steven. Great answer. Nothing to add from my end.
Thanks so much, Steven.
Thank you. Our next question today is coming from James Gordon from JP Morgan. Your line is now live.
Hello, James Gordon, JP Morgan. Thanks for taking the question. One question was just competition in second line. You're going to be the only company with a second-line approval. What does your research suggest about prescriber willingness to use third-line agents in second line, such as Polivy or CAR T? Is this an indication where off-label use is frequently being observed, or you think it will be observed? If I could just squeeze in one other quick follow-up, which would also be, you had really strong OS data in L-MIND, which could be a differentiator. Not a big surprise that that's not on the label right now, are there any plans to explore trying to get that added at some point in the future?
Roland will address the first part of the question, and Malte the second part.
Yes, James, given the very high unmet need for these patients once they relapse after their first-line treatment, and the fact there was no other treatment available, indeed there is a range of different treatments that are used by physicians and many of them off-label. This now changes, of course, with the approval that we've just seen for MONJUVI and for lenalidomide, where we now for the first time do have an FDA-approved second-line options for these patients in high need. Regarding the overall survival data, absolutely, that's a very compelling data point. Perhaps I ask Malte to quickly comment on how this will be used and disseminated in medical education.
Yeah. Thanks, Roland. Indeed, we are very pleased with the long median overall survival we are observing in our recent cutoff that we presented this year at ASCO and EHA. Median overall survival, to remind you, is close to three years. We are not sure if the overall survival will make it into a potentially updated label because, as you know, FDA prefers to see randomized studies to include time-dependent endpoints. We would be interested in discussing with FDA potentially to include our updated longer duration of response in an updated label. If you remember, the median duration of response is also close to three years in the updated data set. This is something that we will certainly entertain, but we have not yet had a chance to discuss this with the agency.
Thank you. Our next question today is coming from Vikram Purohit from Morgan Stanley. Your line is now live.
Hi. Thanks for taking my question. First, quick one on timelines. Just wanted to clarify when we could see some initial data from the frontMIND study. Secondly, just wanted to see if you could talk a bit more about the design of the intended first-line study that you mentioned is going to start early next year. I know you mentioned that you expect completion here in 2025, just wanted to see if you could also comment on kind of the data point at which we could start to see some initial data here as well.
Malte, do you want to take that one?
Yeah, sure. On the BEAMIND, we expect to be at the tail end of the study around 2023, 2024, depending on how enrollment goes. Enrollment for BEAMIND also goes quite well. With respect to the frontline study that we will start at the beginning of next year, I can only speculate at this moment. Yeah, I can say that we were positively surprised by the enrollment curve that we have observed for the firstMIND study of our phase I-B/II study. Despite the corona situation, we are ahead of the enrollment forecast. In my interpretation, this shows how great and high the interest is of the scientific community in testing MONJUVI in combination with lenalidomide in the frontline setting.
It's impossible for me to look five years into the future, but today we have seen much greater support by the hospitals and physicians than I would have expected.
Thank you. Our next question-
Go ahead. Next question.
Certainly. Our next question is coming from Etzer Darout from Barclays. Your line is now live.
Hi, everyone. This is Paul on for Etzer. Thanks for taking the questions and congrats on the approval. Just a quick one from us. I was wondering if you'd comment on the dialogue you've been having with physicians on diagnosis of patients during the COVID-19 pandemic, and whether or not it has changed, if it has, and how you're planning to manage physician interactions during the early days of launch. Thank you.
Roland will answer your question.
Go ahead.
Yes, Roland.
Paul, this is Roland. Our teams are very close to how our customers are interacting with patients. What we see in the U.S. is that this differs across the country depending on the local situation. Our teams are making sure that we have the range of options available virtually to make sure that no matter where a healthcare professional is, that we can appropriately interact and meet the needs of the healthcare professionals for the information they need to actually make the right prescription choice for their patients. Regarding the interaction with healthcare professionals, I actually would like to invite Barry to comment, because beyond the preparation that we've been doing on the MorphoSys side for our launch, which is starting end of this week, Barry and team of course, have been out there every month and been very successful in their interactions for their other portfolio.
Yeah, Paul, just going back to our JAKAFI experience, just to see how we've been performing during the COVID period. We do know that cancer patients in general, the new patient visits dropped off for all drugs in April and May and started to come back in June. Our interactions have been very successful for JAKAFI, because we have such deep experience with these offices and hospitals that we're able to virtually get in, provide educational material and so forth, for all of these physicians. Our experience with PEMAZYRE is very relatable to the launch of MONJUVI because we know that oncologists, hematologists want to hear about new drugs, and they really wanted to hear about PEMAZYRE, and that allowed us to reach them virtually, video conferences, speaker programs and so forth.
I know that will occur as well with MONJUVI as we get out there and start talking to them.
Got it. Thanks.
Thank you. Our next question is coming from Evan Seigerman from Credit Suisse. Your line is now live.
Hi, all. Thank you so much for taking my question and really congrats on the rapid approval. One housekeeping question. With this approval, I assume there is a milestone payment from Incyte to MorphoSys. Can you provide any color on the size of that? Higher level, with no real consensus for kind of guidelines for the second line setting, how important is it for MONJUVI to get on the guidelines or to really kind of establish these guidelines, either in the U.S. or Europe to help solidify the launch? Thank you so much.
Christiana?
Well, I'll answer the second question first. Just in terms of guidelines, actually, the most important one in the U.S. is NCCN guidelines. MorphoSys, together with Incyte, has already submitted a request to be added to the guidelines for treatment of patients with diffuse large B-cell lymphoma. Other compendia will be updated as well. The NCCN is already in. We think that there'll be a rapid addition to the guidelines for diffuse large B-cell lymphoma as other drugs have been added very quickly that have been approved recently.
Okay.
In terms of your first question on the milestones, in general, we have not disclosed the breakdown of the milestones. Regarding this particular event, given that the FDA decision was expected to come soon after the signing of the deal, we had incorporated this event in the upfront payment, so there won't be an additional milestone.
Okay. Thank you for the color there. Appreciate it.
Thank you. Our next question today is coming from Daniel Wendorff from Commerzbank. Your line is now live.
Yes. Good afternoon, thanks for taking my questions. My main question would really be, can you remind me on the key marketing message for MONJUVI again? In particular, can you use the shown PFS and OS benefits as well as the BEAMIND data to market the drug? Also a housekeeping item, just to see whether I got this right. The confirmatory trial for the approval, will this be the first-line trial you have on the way which will begin in early next year? Thank you.
Daniel, thanks for your question. This is Jean-Paul. I'll quickly answer the second part, and Roland will address your messaging question. The confirmatory trial will be the pivotal first-line trial to start early next year.
Roland, for the messaging.
Yes, Jean-Paul. Our messaging is straightforward. For second-line patients with relapse refractory DLBCL that are not eligible for autologous stem cell transplant, MONJUVI label might provide the deep response and the durable response that you have been looking for, all with a safety profile that is sound and tolerability that is sound, and an accessibility that lets you use this targeted CD19 therapy in your practice, no matter whether in academic setting or in a community setting.
All right. Thank you.
Thank you. Our next question today is coming from Michael Schmidt from Guggenheim. Your line is now live.
Hey guys, thanks for taking my questions and congrats on the approval. Two questions from me. Around the phase I-B study in frontline DLBCL, I was just wondering how we should think about the efficacy bar in first-line patients and what type of result in the phase I-B study would increase your confidence in the outcome of the planned first-line phase III trial. The second question for the Incyte team was just on the U.S. profit share calculation. I was wondering if you could help us with some additional guidance on the marketing SG&A allocation to the joint venture. I think you mentioned 150 sales reps in total. Just wondering if I think about this correctly and what added marketing expense might be allocated to that JV. Thank you.
Hey, Malte, can you take the first part of the question, the safety and efficacy of frontMIND, and Christiana, the second piece. Thanks.
Yep. The frontMIND study was not designed to look at the efficacy comparison between standard of care R-CHOP versus R-CHOP plus MONJUVI lenalidomide. It is a safety study with a total of 60 patients. As I said, I think this week or so, we expect completion of enrollment and we have, of course, monitored very closely the safety signals and are very happy and content to say that so far, nothing unexpected emerged in this study. We believe that we have a high chance to start our pivotal frontline study as planned. That's maybe all I can say at this moment.
Hi, Michael, it's Christiana. Regarding your second question, this is a 50/50 profit share, so everything is split 50/50 between the two companies. In terms of the SG&A or sales and marketing costs, both FTE-related costs as well as external costs, marketing support and other, will be split 50/50 between the two companies.
Just to clarify, Michael, it's not 150 sales reps total between the two companies. It's about 150 field-based people, and that includes medical affairs, our MSLs, our oncology clinical nurse educators, and market access people.
Understood. Thanks so much.
Thank you. Our next question today is coming from Suzanne van Voorthuizen from Kempen. Your line is now live.
Hi, guys. Congrats with the approval and thanks for taking my question. Just one with regards to the development in first line. You plan to start the Phase III early next year. That plan has been there for longer. I was just wondering if there's anything that you've seen so far in terms of signals from the frontMIND trial, whether that fed into the decision to start that study and design, like sample size and such. Basically, what should we expect for a Q4 data release from the phase I study? Will it be on all patients? What type of data will you report?
First of all, again, we are extremely encouraged by the fast enrollment and recruitment in this study. If you see something like this, it's typically a sign that the investigator community is really excited about a treatment or potential new opportunity here. Again, the study was not designed to make any preliminary conclusions regarding efficacy. We designed the study to generate a robust safety signal in order to ensure that the bigger frontline study, that will be the pivotal study, will be conducted in a safe manner and will be predictable in terms of safety signals. Again, so far, we have not observed any unexpected safety signal, which is really encouraging for us. That's all.
Maybe just to follow up, because for the Q4 data release on the phase I study, what should we expect there?
I'm not sure when we will be able to share the data. It depends a little bit on how fast we are with the analysis phase. I doubt it will be in Q4. We are doing the best we can to analyze the data as quickly as possible. We'll share the data as soon as we have a robust data set.
All right. Thanks a lot.
Thank you. Our next question today is coming from Mara Goldstein from Mizuho. Your line is now live.
Thank you for taking that question. Thanks for discussing the competitive landscape. I'm just curious as to what or rather which treatment do you think will pose the most significant challenge to displace as you begin to roll out MONJUVI? Secondarily, you mentioned that MONJUVI will launch shortly. Can you discuss what are the rate-limiting steps that need to occur ahead of product availability? Thank you.
The most significant challenge we know, this is Barry, sorry, from Incyte, is the most used in the second-line setting is Rituxan and various chemotherapy combinations, even though there's no approval there. That's used. The data from these various studies in the second-line setting with these chemo combinations, like Rituxan and GemOx, for example, is variable. In fact, it looks like the duration of response where MONJUVI does really well, the duration of response for these Rituxan chemotherapy combinations looks to be much less. That's where our advantage is.
Okay.
Roland might be able to give more information, but I think the MONJUVI will be available by the end of this week.
Oh, okay. Thank you.
That is correct, Barry. Yes.
That's correct.
Our next question today is coming from Matt Phipps from William Blair. Your line is now live.
Hi, thanks for taking my question. Congrats on the broad label. I was wondering if you could provide your latest thoughts for the first-line trial around either enrollment criteria or maybe endpoint hierarchy, specifically thinking about cell of origin or risk status given the results of the robust trial with lenalidomide. Also, are you considering using baseline NK cells as a biomarker in this trial?
Roland, can you take that one?
With respect to the enrollment criteria, we use, of course, standard enrollment criteria with respect to the definition of untreated DLBCL patients. We have focused on those patients with a bad prognosis in terms of IPI score. We want to enroll those patients that have an IPI score of 3, 4, or 5. We believe that based on the data that emerged last year with respect to the robust study, the ECOG 1412 study, the potential efficacy for the combination of MONJUVI and lenalidomide in this patient population may be quite significant. Of course, we will continue to enroll the same patient population in our pivotal study compared to the ones that are currently being enrolled in our frontline study.
Thank you. Ladies and gentlemen, we have time for one more question, and that is coming from the line of Stephen Willey from Stifel. Your line is now live.
Good morning. Thanks for taking the questions, and congrats on the approval. Just a quick question. I noticed that there's a bit of a discrepancy just between the updated EHA data set and the label data set. It looks like the label excludes around nine patients, I think seven of those patients were CR patients. Is this just a byproduct of FDA requiring a centralized DLBCL diagnosis? I guess how, if at all, do you know this might impact the updated DOR data that was presented at EHA? Thank you.
Yeah. Hi, Stephen. It's Steven from Incyte. You're exactly right. The FDA included the centrally confirmed diffuse large B-cell lymphoma population in terms of labeling, and that's how they ended up with their patient number compared to what's been presented in prior presentations. It's as simple as that.
Got it. Very helpful. Thank you.
Okay. Thanks.
Thank you. We've reached the end of our question-and-answer session. I'd like to turn the floor back over to Anja for any further or closing comments.
Thank you. Ladies and gentlemen, this concludes today's conference call. The Investor Relation teams of both Incyte and MorphoSys, we will be available for additional questions. For now, we thank you for joining the call. Have a good day, and bye-bye.
Thank you. That does conclude today's teleconference. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.