Oncopeptides AB (publ) (ONCO) Earnings Call Transcript & Summary

Hello, and welcome to the Oncopeptides Post-ASH Webcast Conference Call. [Operator Instructions] Today, I'm pleased to present CEO, Marty Duvall. Please go ahead with your meeting.

Thank you very much, and good morning and good afternoon to everyone. Really excited to provide some details coming out of the very exciting ASH meeting and specifically focused on our program and our excitement around melflufen, its continued development and our pending launch of the product. I am joined today by Dr. Klaas Bakker, who is our Chief Medical Officer, and he'll be providing perspectives; along with Jakob Lindberg, our Chief Scientific Officer. So moving to the next slide. Just as a disclaimer, we will be making some forward-looking statements today based on our interpretation of data and ask everyone to look deeper into our risks and filings to understand the balance. So next slide, please. So just thinking about the overall picture here, a lot of exciting updates. Multiple myeloma continues to be an area where the science is moving quickly; very exciting landscape in terms of new products launching; new combination therapies that we believe will advance patient care as we move into the next decade. And certainly, as we look at that treatment landscape and the development plan of melflufen and the data that were generated, we're really excited about the continued prospects for melflufen as a foundational treatment in the landscape of multiple myeloma. Moving to the next slide, which provides an overview of the ASH meeting for us, so Slide 4. So very successful meeting for us, highlighted by 8 clinical presentations -- or 7 clinical presentations, and 1 being an oral presentation. So we'll hear from Dr. Bakker on the ANCHOR trial. Again, this is a very important part of our clinical development program, as we see the data in combination with daratumumab and the early combination data with bortezomib, showing that our drug is combinable with some of the other workhorse agents in the treatment of multiple myeloma. So we'll provide you some details on that as well as how that data fits into the overall landscape and looking at some of the trials that have historically been communicated and those that were updated at the ASH meeting. On the poster presentations in the HORIZON, and obviously, HORIZON sits at the pivotal point for us. This is our registrational trial under review, active review at the FDA. One of the questions we always get from key opinion leaders is the effectiveness and the differentiation of melflufen in the space of patients who are refractory to alkylator. So one of the major data cuts of the HORIZON data looks specifically at patients with prior alkylator therapy. And Jakob is going to go to a lot of detail to explain that data and position it accordingly. And you see a list of other patients with various high-risk extramedullary disease that was presented in poster format. So really pleased with the HORIZON data and certainly look forward to beginning to promote melflufen in markets around the world based on that pivotal trial. We also, on the preclinical side, obviously, as we work to remain and build ourselves as a foundational treatment going forward, can't ignore the preclinical data that continues to differentiate melflufen. Here, we showed efficacy and subsets of various highly resistant cell lines. So looking forward to that translating into the clinic. And also, an interesting preclinical poster that may speak to some of the quality of life benefits that we see in future clinical studies and some of the anecdotal things we hear from the clinic now around bone pain. So again, our overall perspective is that the ASH meeting was a very exciting one and supports the current development plan and data that we're generating that we think will make melflufen foundational. So with that, I'm going to turn it over to Dr. Bakker to go through some of the ANCHOR data. So take it away, Klaas.

Yes. Thank you, Marty, and hello, everybody. So we can go to the next slide. We had a very exciting presentation on ANCHOR, which shows the data of both the ANCHOR data sets, one on daratumumab and one on bortezomib. And we can go to the next slide to start with the daratumumab data. But first, we will have a look at the design of the study. So important to note that this is a Phase I/II study, a so-called basket study, where we separately enroll patients in combinations with melflufen with either bortezomib and daratumumab, 2 of the most widely used drugs in the multiple myeloma space as of today. So the primary efficacy parameter was progression-free survival, and we will speak to that in a minute. But we also, of course, will look at overall response rate and overall survival, and that's an important. This data has provided us with the necessary insight when it comes to the adverse events and the overall profile of these combinations. And more to that on the next slide. So if we look at the daratumumab data, it's important to note that across both those regimens we have very encouraging overall response rates. On average, it's 73%, but both hold up very well and are in the same ballpark. I'm encouraged by this for our LIGHTHOUSE trial, which is about to enroll patients around year-end, hopefully before year-end but maybe early next year. We're still waiting for that. But it shows that we are very well combinable with 33 patients. And if we look to some of the more specifics, and we can go to the next slide, please. We look -- on the left hand, we look at the swimmer lanes of these patients of both the 30-milligram and 40-milligram cohorts. And as you can see, we still have a lot of ongoing responses. So this is a very exciting signal that patients are able to stay on treatment that long. And with a median duration of response of 12.6 months, we have still 5 of the 33 patients ongoing at the time of the data cutoff. Important, this was a really recent data cutoff, so this data cutoff was made in October. And encouragingly, the median progression-free survival was close to 13 months, which is very encouraging in these patients that are generally refractory to either an IMiD or a PI or even both. OS data are still immature, which is, I think, a good sign given the long median follow-up of 18.4 months. If we speak to the adverse events, and that's not shown on this slide, but I just want to reemphasize that there were no new signals identified, no worrisome signals. So we are really confident that the combination of daratumumab and melflufen will make an impact in the clinic in the future. If we then go to the next slide which speaks about the combination data with bortezomib. This is not as mature yet as the daratumumab data set. But the overall response rate of 62% -- and please note, these are only 13 patients, but this response rate holds up pretty well if we look at competitors, and we'll go to that in a minute. The median treatment duration was 8.7 months, which actually made us not being able to calculate the PFS yet. So of course, we will provide that in the future. But from an efficacy perspective, we see a decent to good signal in terms of overall response rate, and this actually also encourage us to think about future combination trials with bortezomib, where this seems to be a good platform for us to expand further on. Safety, also here, no new signals, no things that puts a question mark there. So also here, the way is free, so to speak, to further build on the combinability of melflufen. Now if we take a look at the next slide, Slide #10, I believe. We see -- on the upper half, we see the ANCHOR data represented. On the left side, the daratumumab data; and on the right side, the bortezomib data. And if you look at the blue arrow going from the left to your right, this represents the refractory stages, with the more refractory the patient is, the more to the right the box is presented. So on the far right hand, you have heavily refractory patients, typically double refractory; whereas on the very left side, you have patients that may not be refractory but also relapsed. And only a small percentage of patients are then included at our refractory. So we've tried to actually line out the magnitude of refractoriness of the patient population that we look at. And if we then look at where we position ANCHOR, we compare really well with the data that have just been presented, being the APOLLO data with the new subcutaneous daratumumab formulation, and our data are very much in line. It's not somewhat better than the APOLLO data. And important to note is that also the APOLLO data set included some patients that were not refractory to previous lines of treatment. And so for the daratumumab arm, very encouraging. If we look then at the bortezomib data, we actually only have an overall response yet to report. So some disclaimers there on the maturity of the data. But overall, if we look at other combinations with bortezomib, we feel encouraged by this data, given the overall response rate reported earlier. But as you can see, both in the OPTIMISMM trial, CASTOR and CANDOR trial, patients were way less refractory than they are in our ANCHOR trial. So we feel that we hold up really well there. And taken together, this actually solidifies our position, we feel, in terms of combinability with major drugs in multiple myeloma. And with that, I'd like to hand over to Jakob Lindberg, our Chief Scientific Officer, to talk more about the HORIZON data and some of the competitor data.

Thank you very much, Klaas, and hello, everyone. This is Jakob Lindberg. I think you can go straight to Slide #12. Thank you. When a trial becomes pivotal such as HORIZON, it's extremely important to see a consistent level of consistency in the activity level you measure across various subgroups. It's also important to measure parameters that might support utilization or show how the drugs would be utilized in the clinic. And all the posters that came from the HORIZON data set at ASH this year are represented on this slide, and they all speak to this. So we had a poster talking about the activity of melflufen plus dexamethasone in those patients with high-risk cytogenetics in HORIZON. We talked about the activity of melflufen plus dexamethasone in elderly patients that is sometimes a very tricky population to treat because of they get an increased amount of so-called comorbidities, and they are also scoring higher on various frailty indices, making it harder to treat because you get adverse events more easily. We also looked at patients with extramedullary disease. And as you know, we presented this already at the [ MWD ] meeting in 2019, but we continue to see a very encouraging signal in these extremely hard-to-treat patients. And we feel extremely encouraged actually by the activity signal we have. And we will, of course, continue to explore that going forward. We also looked specifically at patients that were alkylator-exposed and refractory. And since melflufen is a drug that has a dual nature, it is both an alkylator and a peptide-drug conjugate, it is important to show that the drug actually has a differentiated mode of action. So this data set is a data set that I will spend some time on, on the next few slides, but not yet, to show you all how this drug actually is highly differentiated compared to the standard alkylator class. We also provided 2 additional data sets, and one was about quality of life where we believe that we have a very strong signal that this drug benefits patients, not only from a tumor burden reduction point of view, but also from a quality of life point of view. That when you talk about the cancer that is incurable is an enormously important parameter. And then finally, we have a supporting data set for reimbursement discussions or pricing discussions, which is about the adverse events and how they link to hospitalization and hospitalization rates. You can see the poster numbers here. And since this presentation will be available on our website, it makes it easier for you to also find the relevant data sets. Next slide, please. When it comes to alkylator refractoriness, I understand that this is a busy slide. And you should first note that we did not only include HORIZON patients in this analysis. We also included our patients from O-12-M1, and that is why you see that there are 202 patients completely represented in this analysis. And the second thing is that this is complex. And the reason for this is that in the modern treatment paradigm, alkylator therapy is very much used as the ultimate salvage therapy. So when a patient has failed on everything else, you throw together alkylator cocktails or alkylator-based cocktails to try to see if you can fight the disease. And this means that, when you measure alkylator refractory status, you're not yet measuring alkylator refractory status from a biologic point of view. You also get an inherent bias for more and more ill patients with more and more severe disease, that is, of course, harder and harder to treat. And that makes this analysis tricky. The best way to single out these patients that actually are more or less end of life, unfortunately, is to look at the column to the far right of this picture, which is exposed and refractory to alkylator in 2 or more lines of therapy. That is they are alkylator refractory in line after line after line. This more or less means that they are on ultimate salvage. And at this stage, you don't really just measure alkylator refractory anymore from a biological point of view but also these other parameters. And I will show you how this matters. If we look to the next slide, please. On this slide, you see the various response rates and across these different categories. And to make it simplistic, you have, from the left, patients with no prior even exposure to alkylators, all the way to the right in this picture, where you see patients that are exposed and refractory to alkylators in 2 or more lines of therapy, many of them 3, 4 times. And as you can see, the response rates hold up really, really well, until you get to the last category with 33 patients. Otherwise, the response rate is 50%, 27%, 34%, 23%, 35%. And as we all know, if you have no single-agent activity plus/minus steroid between 20% and 30%, you're in a very good spot. That is where all major drugs in myeloma land. But in the rightmost category here, our strong belief, and I'm going to come to that, is that we are not measuring alkylator refractoriness anymore. We are measuring patients with inherently a very bad prognosis because they have been through everything, including ultimate salvage and failed on that salvage therapy, unfortunately, or the therapy has failed them is a better expression. And the single best line to understand this is if we go to the next slide, please. On this slide, we have shown various alkylator-based regimens that the patient is refractory to and then what the response rate are to the far right. The most important line here is high-dose alkylator therapy outside of stem cell transplant, the first line. This means that you give -- you pulse the patient with very high doses of alkylator therapy in an attempt to try to fight the disease. And these patients have progressed on these type of therapies that are very, very tough on the patient. And despite this, we achieved 24% response rate. So they are basically refractory to high-dose alkylator-based therapy, and we still get a normal response rate in these patients for being late stage. And to us, it just speaks to the differentiated mode of action and the fact that we actually show activity here. Basically, what does the peptide-drug conjugate adds, and that number shows that. On the next slide, we are trying to summarize ASH from a multiple myeloma point of view. And it is a very large meeting, so this is not easy. But simplistically, there were new -- there were no major, major news at ASH with regards to multiple myeloma, but there were plenty of updates. And if you look at the main areas of interest for us, I would argue that daratumumab, that Klaas went through before, we combine very well with, continues to impress, including the subcutaneous formulation FASPRO, which shows equivalent data to the intravenous one, which is very important because the administration schedule of that one has been tricky for a lot of clinics to manage due to the times required. When it comes to selinexor, they continue to provide plenty of updates across several clinical trials, but it basically shows the activity pattern we have seen before and with non-hematologic toxicities continuing to be a challenge in line with the REMS program that selinexor got. Belantamab is very much the same where several studies are ongoing, and they provided updates on those, including, of course, the long-term follow-up of DREAMM-2, which I personally find -- found very interesting. But once again, it was in line with previous data and no new major updates or news, I would argue. And the same pattern holds that keratopathy continues to be a challenge with this drug. It needs management. On -- in the CAR T field, I would argue that the activity signal seen with -- or the efficacy signal seen with anti-BCMA CAR Ts continues to be very impressive, but all the practical challenges remain. And since the practical challenges is the key hurdle for these drugs or for these cells to be used, the little tidbit of news from the J&J platform that they seemingly get less cytokine release syndrome than the other CAR Ts, I think, is the most interesting piece of news because that could potentially allow for outpatient utilization. We have to see that. But that, I think, was the most interesting piece from the anti-BCMA CAR T field. When it comes to the bispecifics, anti-CD3, anti-BCMA, they continue to impress. And when we talk to KOLs, I think most KOLs expect, but that the proof is in the pudding. We have to look at more data -- continues to expect a bispecific construct to sort of take the BCMA field at the end of the day. Obviously, more clinical data is needed, but that is more or less the general consensus out there if you talk to KOLs. Pfizer has a strong data set that actually wasn't presented at ASH, and that is because they presented this at an Investor Relations meeting. But personally, that is the data set that interests me the most in the bispecific field. And we will, of course continue to monitor this. We feel that there's a very strong rationale to combine melflufen with an anti-BCMA agent, but we need to see which one we should combine with under the assumption that we get approval. I think back to Marty and the Q&A session now. I believe we have a slide saying Q&A. And then the operator will guide you through how those questions and answers will be handled.

Thank you, Jakob, and thank you, Klaas. If we forward to our news flow slide, maybe in summary, just putting a bow on the 62nd Annual ASH Meeting. We're really excited about ASH, what we put forward with respect to HORIZON. Preclinically, on the differentiation side, obviously, all the cuts of our pivotal product through the HORIZON trial, and importantly, that walk through that Jakob provided on alkylator refractoriness that we feel emphasizes the translation of the preclinical research that we are indeed a different drug, a differentiated mechanism of action and that the peptide-drug conjugate, melflufen, can be a fundamental player here in the management of multiple myeloma. The ANCHOR data put into perspective shows that important combinability as we see the way these products are used in the commercial landscape today and being able to do that successfully from not only a safety perspective, but also seeing a very encouraging activity that we've seen with the melflufen combinations is truly exciting. So looking at our news flow and value drivers, we see the green now are everything that's happened. So 2020 is nearly behind us. There's one more milestone in 2020, the publication of the HORIZON trial in the Journal of Clinical Oncology. Stay tuned. We believe that, that will occur this week. So really excited, very timely to, of course, have our pivotal publication as we look to move into the commercialization phase. As we turn the page on 2021, it will obviously be a transformational year for Oncopeptides with the launch of melflufen, with the potential accelerated approval in the U.S., the commercial launch. As Klaas was alluding to, the first patient in, in the Phase III trial, very important -- or first patient into a Phase III combination trial, I should say, with the daratumumab combination and the LIGHTHOUSE study, expecting that to occur soon. And one thing we don't want to get lost in the mix here is the fact that our peptide-drug conjugate platform is delivering more than just one drug. As you know, we have a sister analog to melflufen that we put forward an IND-approved and anticipate a first patient in, in a stem cell transplant. So this new formulation provides the opportunity for hydro, our sister analog, and new formulation provides the opportunity to deliver high-dose product to patients with high unmet need undergoing a second transplant. So very exciting from the overall portfolio perspective. And of course, as we step back and think about the big picture for Oncopeptides in 2021, the OCEAN trial. And that direct comparison to pomalidomide will be very important for us. Still projecting that we would have top line results of that trial at OCEAN, and we'll continue to provide updates as we look to expand our footprint and commercialize in Europe. So very exciting times. With that, I will stop, and I'll turn it back over to the operator for any questions regarding ASH, our take on ASH and Oncopeptides in general. So thank you very much.

[Operator Instructions] Our first question comes from Viktor Sundberg from ABG.

So first one on ANCHOR. You have quite a lot of right censored patients that are due to ongoing response. Is that due to COVID-19? And what, if any, are the implications of this on your results since some of these patients are on the left side of your median PFS? And also, would you be able to go back to these patients? Or are they lost to follow-up?

Thank you, Viktor. And I'll turn that over to Klaas for his perspective.

Yes. And thank you for the question. It's an important question. For ANCHOR, we don't feel that COVID-19 has had an impact there. These patients are definitely not lost to follow-up. I think it is also the result of the fact that we had a very late data cut in order to present the update with PFS, that we don't have all the events on the individual patients in yet. But taken altogether, we had seen no impact of COVID-19 on the ANCHOR trial specifically.

And Viktor, this is Jakob. Just to add, we have had this discussion before. As you know, bad news travel fast in clinical trials. And good news travels slow. The moment the patient progresses on the disease and needs to have an end of treatment scheduled, it goes really fast and enters the system. So when you see these things that data hasn't been updated, it's mostly due to late data cut. And if the news are bad, it travels fast. So the best assumption is to assume that they are disease-free, of course, but we can't make that assumption unless we have an additional data point in the system, of course.

Okay. And then how should we think about these results and the read across maybe to your future LIGHTHOUSE trial? I note that in the 30-milligram group, but it seems that the better response might be driven, but -- by that this group is a bit healthier, maybe a bit younger. I note that none of the patients, for example, were refractory to an IMiD approach to some inhibitor. And also, could you comment on the most common dose reduction in the study? I mean, you show here a 40-milligram dose group, for example. Maybe if you have had dose reductions, it might be a 30-milligram dose group, maybe.

Happy to comment on that. I think I heard you say that were not refractory to a PI or IMiD. In ANCHOR, they were actually refractory to PI and IMiD or even double refractory. If we look at...

No, no, I mean, in a 30-milligram dose group only.

In the 30-milligram dose, we had 3 patients [ by head ] that were alkylator -- or not alkylator, but refractory to either an IMiD or PI. So you're right that not all patients were refractory in the 30-milligram cohort. Whether that impacts outcome, it's difficult to say, given the small numbers. But important to note is that we feel that in both those cohorts, we see kind of similar efficacy. We have made the decision for LIGHTHOUSE to go with the 30-milligram dose as an important one, but that is primarily driven by the fact that the adverse event profile seems to be somewhat better with the 30-milligram cohort without losing efficacy. So that is the main driver to go for the 30-milligram dose in the LIGHTHOUSE study. If I go back and just put it in front of me, if the 30-milligram, 3 patients were IMiD refractory. And you're right, they were not PI or double refractory. But I think given the very low numbers, we cannot speculate whether this plays a role in the efficacy. But it is the fact that we will move forward with a 30-milligram dose in the LIGHTHOUSE study.

And this is Jakob. Please note that the patients there that are not IMiD refractory are PI-intolerant, so that is -- or to an IMiD. I don't have those numbers in front of me, how many that have peripheral neuropathy. But as you know, an inclusion criteria in the trial was that you had to be refractory or intolerant to at least an IMiD or PI or both.

[Operator Instructions] Our next question comes from Boris Peaker from Cowen.

Great. I just wanted to focus on this strong alkylator refractory data we just talked about, particularly in these late-stage patients. Just curious, do you think that any of this is going to be mentioned in the label somehow? And if not, what is your strategy of using it as a marketing tool?

Jakob, do you want to start with that one?

I can start with the data with a small reference to label, and then you can discuss the marketing piece, Marty. Is that okay?

Yes, that's fine.

Yes. So Boris, so of course, I don't want to comment on the ongoing label negotiations with the FDA. But obviously, we would like to have something around alkylator refractory status, and then we'll see where that lands. I -- we did not sit on this data set in this -- at this level at the submission where we had broken it down per treatment category. I believe just -- I think you implicitly stated that, and we have talked to several KOLs, the fact that we sustain response rates in patients that has been on mostly then the regimens called DCEP and VTD-PACE because it's not just high-dose alkylator, it's high-dose chemotherapy with a lot of other components to it, is remarkable, actually. And I think we should use that as much as we can in trying to promote the platform. But Marty, please comment on that.

Yes. No, it's a good point. And Boris, thanks for the question. I think as we step back and look at the situation and think about the U.S. market, this is an accelerated approval. HORIZON data set, we know and we've characterized the nature of these patients, and in particular, the 119 that are triple-class refractory. So I think the encouraging thing as we dig into the HORIZON data is that in these subsets, high-risk cytogenetics, prior alkylator exposure, EMD patients, what we see is a consistent level of response activity, benefit/risk profile that demonstrates that melflufen can make a difference for these patients. So I don't want to comment, as Jakob said, on the specifics of a label negotiation and where that might ultimately reside. I think we all feel comfort in knowing that seeing results and results that are consistent across these various lines provides us the opportunity based on guidance from the FDA to talk specifically about the patients that benefited from treatment in the way that the universal population did in the HORIZON trial. So as we get a final label and work through our strategy, we'll be sure to come back on this one. But I really appreciate the question.

Our next question comes from Bertrand Delsuc from Biotellytics.

Yes. Just to start about ANCHOR, do you have data about the MRD status of your responders? And secondly, if I remember well, the 30-milligram was, let's say, already envisaged to be the dose for LIGHTHOUSE a few months ago, but perhaps I'm mistaken. And so I'm a bit surprised that the latest patients have seemingly been all enrolled at 40 milligrams and not 30 milligrams. If you could comment the dynamics of the enrollment in between the arms.

So thank you for the question. And I first would like to add to the part on the MRD status. Now this is gaining interest across the field. At the time of the design of the study, this was not taken into account, so unfortunately, we are not able to provide you with any data points on the MRD status. With regards to the dose that we picked for 30 milligrams, and you're very right to point out that, that was a couple of months ago, the latest patients were actually enrolled before that decision. So while we give an updated number of the patients, the actual enrollment took place before the decision was made on the right dose. So I hope that does answer your question.

Yes. But wouldn't it be, let's say, what if you are about to start the LIGHTHOUSE? So I mean, that now perhaps too late, but it has been interesting to perhaps to consolidate, let's say, the data you have at 30 milligrams. And second one -- or follow-up, sorry. On LIGHTHOUSE, could you comment the choice of the control arm, which is the daratumumab monotherapy?

Yes, sure. And I can start with the second question regarding the control arm of LIGHTHOUSE. So daratumumab is a monotherapy therapy, so to say, so it is not used in conjunction with steroids. So that's basically the reason for taking daratumumab as the control arm for the melflufen/daratumumab combination. If we go back to the question on the 30-milligram...

I can add here. It's Jakob. So basically, we saw no unexpected toxicities, and hematologic suppression is a continuum. And then you get a number, which is called dose intensity, and you get the efficacy numbers, right? And it was just that we get slightly more talks with the combination of 40-milligram plus daratumumab than with 30. And we didn't get an increase in dose intensity due to dose toxicities and similar levels of efficacy. So it was a very simple decision. But to your point, maybe one could have increased the 30-milligram cohort to consolidate the data set, but we felt that we had some solid ground under our feet that it was not a risk or a problem to make the decision with 30-milligram and start the design of the LIGHTHOUSE trial.

And rather that we had multiple cycles in there to make a proper assessment on the dose intensity across cycles. So that's why we're very confident there.

And just as a final point, we have plenty of 30-milligram cycles in the 40-milligram cohort because they needed to dose reduce, right? And of course, those cycles are also part of the final analysis.

Yes, that's what I thought as well. So to resume also on the thrombocytopenia at 30 milligrams versus 40 milligrams, it's lower.

Yes, it's somewhat lower, the thrombocytopenia, on the 30-milligram. So you actually see less need for dose modifications being it either dose delays or reductions. And in the end, it plays out being the same dose intensity between the 40- and 30-milligram, hence, the choice to move forward with the 30-milligram dose for our pivotal LIGHTHOUSE study.

And please note, it's Jakob here, when you look at those tables, when you take weekly measurements of blood draws, you get all the measurements through the nadir values of the myelosuppression. So it means that you don't really catch how many patients that bounce back appropriately and not. Those numbers do not show that. And that is the biggest difference between 30 and 40. It's not how much myelosuppression you have day 14. It's where your myelosuppression is on day 28 when you should give the next dose. And that -- there, the delta is much bigger than the numbers that you see in the table, which is based on the weekly measurements.

Okay. And finally, the last one is about the benchmark data, especially with the data from daratumumab in APOLLO, which was also presented at ASH. And what is interesting is that, indeed, the ORR and the median PFS in ANCHOR are really similar. However, there is one particular point, which is of interest, I think. It is that the APOLLO data in mPFS shows a plateau around 38% in mPFS past 22 months; whereas it doesn't seem -- okay [indiscernible] data [ allowance ] with censoring, okay. But it doesn't seem there is some sort of plateau that's appearing in ANCHOR. I checked a bit the populations. And okay, there are some discrepancies, but could you discuss a bit why we wouldn't see a kind of plateau in ANCHOR?

Yes. Thank you. And this is a very interesting question about a plateau. I think we need to be careful here of interpreting the data. We talk about the cohort of 33 patients when compared to the cohort of over 300 patients. And we have simply not have had the appropriate follow-up time to see if there's a real plateau with ANCHOR. So I feel it's too early to judge whether that's the difference between the 2 treatment regimens. And that's primarily in the numbers and the length of follow-up in the patients that have been enrolled at the second part of the ANCHOR study in time.

Our next question comes from Viktor Sundberg from ABG.

Yes. Just a question on HORIZON also. You show that both patients with high-risk cytogenetics and those without have quite similar data on melflufen and also that patients above the age of 75 had better response than younger patients. Could you maybe comment on these results? And they, of course, seem very good, but I guess a bit counterintuitive as well.

I don't think they are counterintuitive when it comes to high-risk cytogenetics because we have consistently preclinically seen actually that the relative advantage of the drug increases with mutational burden and refractory status preclinically. I think it's too early to state whether that fully translates into the clinical setting or not, but I think this is in line with actually what we see when we do preclinical experiments. The elderly patients is a bit trickier, actually. And I -- it's always tricky when you look at subgroups. It's a very positive signal, and we need to look at it even further. But that's a bit more counterintuitive actually because they should perform worse, and they don't. But we need to look at this much more because we need more patients to actually draw any conclusion from that. But the signal is very good.

Okay. And a final question from me on OCEAN, also the implication for OCEAN, I guess. I guess, the risk with a head-to-head study is that the standard of care is changing as you're doing the study. Do you think there is a risk that daratumumab combos will be used when patients become refractory to REVLIMID instead of just pomalidomide as might have been more of the case when you started OCEAN?

No. No, I think daratumumab will move to the front line. So I basically think that, in that sense, a PI combination makes more sense. You will have patients on quadruplets, of course, with both the PI and IMiD and daratumumab. But I think you're going to see an enormous amount of use of daratumumab plus an IMiD in the frontline setting, which means that the daratumumab/pom combination makes the least sense actually of all these combinations. While you might want to re-treat with daratumumab, you would rather then change at least the combination partner.

Okay. So more patients in the frontline mean that there are more patients that are refractory to daratumumab than when you go back in the [indiscernible], yes?

Or at the minimum, they will be IMiD refractory and daratumumab-exposed, and then you don't want to go with an IMiD plus daratumumab again. That is not the combination you would choose at that point. You would -- maybe you dare to re-treat with daratumumab, but would you -- you would rather then do it with a focus on inhibitor that the patient has not received or, for example, melflufen.

Okay, yes, and congratulations on your results from ASH.

Thank you very much.

Thank you, Viktor.

There appears to be no further questions, so I will hand back to the speakers for any other remarks.

Super. Well, we thank everyone for their participation in this post-ASH webcast. Again, we're really excited about our progress as a company and look forward to a transformational event and 2021. So take care, and we'll talk to you soon. Bye now.

Thank you. This now concludes our conference call. Thank you for attending. You may now disconnect your lines.