This call is being recorded. Welcome to the Medivir Q2 Report 2023. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now, I will hand the conference over to CEO Jens Lindberg. Please go ahead.
Thank you, welcome everyone, logging in or dialing into this webcast. A Friday afternoon webcast, not usually the day we run this, but sort of hopefully we can close out the week with a good session. We have had quite an eventful quarter at Medivir, and we are at a very exciting time for the company and for our lead program, Fostrox, in liver cancer, and we very much look forward to sharing more details in the webcast today. As we move forward, we were planning to be 4 today, we will be 3. We are missing our CMO, Pia, today. She has actually come down with a cold and a fever, and most importantly, she has lost her voice.
You are going to have to make do with us today, and unfortunately, that means you will need to hear a lot from me during the session today. Important information, I will not go through it in detail, it will be. You will find our presentation on the website as well after the after our session today. Let's move into what has happened and where are we on things. With regards to the last sort of three, four months, we are seeing quite a strong... Oops! Hang on. There we go. We're seeing quite a strong momentum in the lead program, Fostrox. We have a very strong interest in recruitment into the study that is ongoing, the Phase 2b. The interest from investigators, the interest from patients to participate is very high.
Most importantly, as we have sort of shared, in the press release earlier this week, we are seeing quite promising signs with regards to clinical benefit for the patients in the Fostrox Lenvima combination. We will share a bit more, sort of on that, sort of in the call today. In addition to that, in the past quarter, we have concluded the Phase 1b dose escalation of Fostrox plus Keytruda, and we do have a safe dose, but we have also said that we are not moving forward with that arm into the 2a part. That arm, and the data is still of high interest, but for other alternatives, and I will come back to that as well later in the call.
In addition, we have also communicated relatively recently that we have now formalized or established an Scientific Advisory Council with some of the world's leading liver cancer experts, participants from our study, but also physicians and clinicians that are not participating in the study. We've kicked that off, The purpose of that council is clearly then to intensify and go into the details of the next steps in the Fostrox development as we sort of start to flush that out. A clear signal that we truly believe we have a drug and a compound that provide benefit for patients, and we are moving ahead with as much speed as we can towards the next phase.
If we, sort of before we go into Fostrox, just as kind of comment, we do have our pipeline overview. Considering the events that have taken place over the last three, four months and where we are with Fostrox as our lead compound, we will focus on Fostrox for the call today, so we will not touch on the other assets. That doesn't mean we haven't seen progress. We are seeing progress across the partnering assets. We are very much looking forward to Phase I initiation, sort of in the coming period for both the USP1 program with Tango and the Metex program with INFEX Therapeutics. IGM continue to dose escalate the Rinapan compound together with their DR5 agonist.
That's moving along nicely as well, but we will not touch further on that today. We will focus completely on Fostrox today. With that said, before showing data, just to kind of take a step back and, and recap, where are we, sort of, where are we playing or where are we developing the drug? It is in HCC or primary liver cancer, where HCC is, is clearly the, the majority. Here's a simplified treatment algorithm, and there are a couple of elements that are important to keep in mind because we will touch on this in the presentation. That is, we are in development currently in the advanced stage in the second-line population.
What has happened as of late or in the last sort of 12 to 18 months, is in that first-line setting, we have a new standard of care, which basically almost every patient gets today, and that is Tecentriq Avastin. That's sort of the true standard of care in first-line. That has bumped the other alternatives to second-line, and it's equally clear that Lenvima is, I wouldn't say that all patients get Lenvima, but Lenvima is the preferred-... option in that setting of the monotherapy or the, the TKIs. That's something that has established itself quite firmly in the past 12 to 18 months. A couple of other comments is that sort of, I think we've said before, but sort of worth pointing out, is that intravenous chemotherapy is not used in HCC. Twofold the reasons.
1, systemic side effects, and 2, a lack of clinical benefit, and the lack of clinical benefit sort of mainly due to the inability to dose properly and get enough concentration into the liver. We do know that chemotherapy is the backbone treatment for most other cancers, but not here. Patients would benefit from it, so we will come back to that a bit as well. That clearly means that there is an opportunity for a liver-targeted treatment that could be combined with both the first-line options and the second-line options.
The program that we're running currently are sort of on, on this slide. As I mentioned, just sort of a recap, we are now in the Phase IIa combo Phase with Fostrox plus Lenvima at the recommended dose of 30 milligrams. As we communicated earlier this week, we've now included 15 patients into the study. If we dig into some details a bit more in terms of what we are seeing and a bit more information about the patient, first, with regards to patient characteristics, you can see on the left-hand side, and this is for the first 17 patients. The last 4 patients, they sort of... It doesn't sort of change the picture, but just in terms of the first patients, you see on the left-hand side a couple of things to note.
One is that, as I mentioned previously, Tecentriq Avastin has become the standard of care in first line, that also reflected in our study. 82% of the patients have received Tecentriq Avastin in their first-line treatment. Again, we're quite aligned from a study perspective, where the current standard of care treatment algorithm is taking us. Two, which is quite important, that is that all of the patients included in the study, they had tumor progression prior to treatment. They didn't come off first-line treatment because they had side effects or any other problems. They all progressed. They all had tumor growth, sort of before moving into second line.
I think that's an, an important element also to keep in mind with regards to when, when we start to look at what are the- what are we seeing from an efficacy point of view with, with Fostrox. Expected split, sort of East-West, virology, non-virology, non-viral etiology. The other part to sort of highlight here is that there is quite a high usage or previous usage of TACE or, or sort of local chemoembolization, indicating then the importance of sort of minimizing primary tumor burden in the liver. As you can, you can see here, that sort of 65% of the patients have had TACE. That's also a number to, to keep in mind, and we will touch on that sort of slightly later in the, in the presentation.
This is a slide that we've shown before, so it's an updated version. On the left-hand side, we have now, we communicated on Monday, included, that we have included 15 patients in Phase IIa. If we add the Phase Ib patients on top of that, we have now included 21 patients in total on the Fostrox plus Lenvima arm. We do have a couple of patients sort of still in screening that could still sort of make it into the study if they are, unless they are screen failures. There are slots that have been allocated.
On the right-hand side, we previously reported two sort of sample patients, and we just wanted to, first, before we go into the other patients, we wanted to give a bit of an update on, on these two, because we've, we've highlighted them in the past. One female Caucasian, and with a hepatitis C background, and this is the patient that has been the longest on treatment, and she is still on treatment. She progressed on Tecentriq Avastin after 5 months, but she has now, or I, I believe it's August 22, she has been on treatment for exactly 12 months. What we're also seeing with that patient is we're seeing sustained tumor shrinkage, i.e., more than 30%, when locally assessed by a local physician and local radiologist.
All sort of the, all data that we are sharing today is with, sort of preliminary results based on local reads. We will also do central reads, of course, and then when we present the study at, at, at a scientific congress, sort of the central read, data will, will clearly be, be part of that, as that is the primary, endpoint. Here we show the local reads. That's patient number 1 and continues to do well. Patient number 2, is a slightly different patient, so that's actually an, an, an additional patient on top of the 21, because this is a patient that is on Fostrox monotherapy. An Asian male who started...
Who weren't able to tolerate Lenvima, but they kept the patient on Fostrox mono, so it's not going to be part of the combination study, but still relevant to see. Progressed on Tecentriq Avastin after already 6 weeks in the before coming into the study. That patient is no longer on treatment, but he had stable disease for 7 months with Fostrox monotherapy before showing a 25% tumor growth at the final or the last scan. Remember that when the tumor grows, target lesions grow more than 20%, then they are considered progressive disease. The patient stayed stable for 7 months with Fostrox monotherapy. So some of these sort of 12 months, 7 months, keep those in mind because we will come back to some of those numbers later.
If we go forward, take, sort of another step. Earlier this week, we communicated that we sort of in the first 10 patients that have been in the study long enough to have two scans and two. Every scan is six weeks apart. That means that they've been on the study drug, or they've been on treatment potentially for three months. What we could see in that sort of those first 10 patients is that seven out of 10 patients were with sustained tumor control, sort of the second scan.
We wanted to share a bit more here because if we look at those patients, if we look at those seven patients, and six of them have now been on study sort of long enough to have a third scan, and that happens after 4.5 months. Of those seven patients, as I said, sort of one patient hasn't reached that sort of time yet. Of the six patients that have, four, again, continued with at least sort of, we call sort of sustained tumor control. That means at least stable disease or tumor shrinkage. Then we have two patients out of the six that where we saw progressive disease at 4.5 months.
Four of them continue to be on treatment, continue to benefit at the 4.5 months mark and, and are moving forward. Again, we'll come back to some of those sort of numbers or timelines from a month perspective, as we, we move forward. The other element is to sort of, look at sort of how is the combination, how are the patient able to tolerate the combination? First, we will focus on the Fostrox side of things, and we are seeing a consistently good safety and tolerability profile, sort of what we saw in Phase Ib continues for, for Phase IIa. One, we look at sort of the number of patients that are able to remain on the starting dose, i.e. the 30 mg, and a clear majority of the patients are. So that's a good first sign.
Perhaps even more importantly, is that we are continue to sort of not see, it's a bit of a weird statement, but we're not seeing any unexpected new safety events in the combination, which is super good. The adverse events are, are sort of manageable and, and transient, and, and as expected, the adverse events primarily that we would see would are, are hematological, as we saw in the Phase I mono as well. Importantly, is that there's only been 1 out of the 21 patients that have discontinued study treatment due to side effects related to Fostrox. With, with cytotoxic drugs like this, that are effective drugs that provide benefit, that is a very low number.
We're quite encouraged by the patient's ability to both stay on drug or stay on the treatment and also stay on the recommended dose. The other element of the safety, sort of tolerability question is the Lenvima part of the combination. If we turn to that, on the left-hand side is the percentage of patients that have required Lenvima dose reduction, and that's been 48% of the patients. That number in isolation isn't perhaps the most important one, but if we look on the right-hand side and we compare that number with what has been shown for Lenvima in previous studies, and that is in the Reflect study, i.e. the sort of Phase III monotherapy study, 62 patients -- 62% of the patients required either discontinuation or dose reduction in that study.
Similar number, when Lenvima was combined with Keytruda in the Phase Ib combination study, 66% of patients required dose reduction or discontinuation. That was an element that we came into the study. One of the things that we were perhaps the most curious about, how would the patients be able to tolerate the combination, knowing specifically that Lenvima can sometimes be a challenging drug and there's a high level of those reductions, and then adding a cytotoxic drug to it, was a question mark. As I said, sort of we're quite encouraged by the patient's ability to stay on recommended dose and stay on treatment. Let's put things a little bit into perspective in the sense that sort of some of the numbers I showed previously.
When we look at what has been shown previously in second line, we are seeing. This is data, on the left-hand side is Progression-Free Survival, on the right-hand side is Overall Response Rates, all from previous second-line studies in HCC. Sort of they do vary a little bit, but sort of relatively close to each other. If you look at the sort of the PFS numbers on average, somewhere along the lines of, of 3.5 months, with regards to Progression-Free Survival or time until sort of tumor starts growing again. Then that number is, is sort of, it's kind of drawn up a little bit by cabozantinib as well, as the 5.2 months is, is a bit of an outlier. That is what we've seen in the past.
Hence, coming back to, as I said, sort of we can see the, a chunk of patients that are able to sort of stay on fostrox + Lenvima for 4.5 months, sustain tumor control, and where we're also seeing tumor shrinkages across a number of the patients. That sort of is encouraging as we, we look at the benefit, in this study versus what has been shown in this quite difficult-to-treat population. Similarly, the Overall Response Rates are sort of on average, sort of single-digit numbers. Again, what we're seeing in the study thus far, from a clinical patient benefit, we are quite encouraged by. With that, I'll stop from a, from a patient data perspective.
Remember, I spoke a little bit before about the number of patients that have received TACE, that are indicating a signal that there, there seems to be a, a, a keen interest and an importance of, of, treating the primary tumor burden in the liver. That's also something that we are getting strong feedback from our advisory council and others, and we wanted to sort of touch a little bit on that. I'll, I'll leave it to Fredrik to go through that.
Thank you, Jens. So if you think about different cancers, you will appreciate that liver cancer or hepatocellular carcinoma is different in some respects. The first one being that the tumor actually arises in the background of underlying liver disease. Vast majority of the HCC patients will have liver cirrhosis. Irrespective if they have an a viral etiology, either hepatitis B or hepatitis C virus infection, or excessive alcohol abuse, diabetes, obesity, or metabolic syndrome, all these converge in liver injury and inflammation, then leading to liver cirrhosis and reduced liver function. In this context, the tumor grows, and this means that the patients will have actually two diseases in the liver: the tumor and the underlying liver disease.
This is, this is really, different from, from many other, cancer types. In contrast to, to many other cancer types where metastatic disease is, is really, one of the, the causes of, of death, in liver cancer, as you, see on the, the right side here, the tumor in the liver and, and the primary liver disease is the cause of death. As a consequence of this, treating the local liver, tumor is, is really, really, important. If we move to the next slide. As Jens pointed out, one of the, main treatments that are given to patients, in the intermediate stage, that is, patients who have not reached the advanced stage and, and are not treated systemically, is the local regional, treatment, with chemoembolization.
The graph here depicts the response at consecutive TACE treatments. There are several limitations of TACE. You obviously need to reach the tumor. You can treat one lesion at a time, but many patients will have several sequential TACE treatments. If you look at the graph here, which depicts the different response, complete, partial, and stable disease, they, you would have a initial response at the first TACE treatment, which is fairly good. It's usually not very durable, but still you have a response locally at the treated tumor. But as you see, that response diminishes with sequential TACE treatments, and you lose the ability to actually get a local regional control of the tumor.
In the end, you will not have a good response by increasing the number of TACE treatments. As a consequence of the TACE treatment, if we move to the next slide, there's also a consequence in terms of, of liver damage. The patients will have an injured liver by the course of the liver cirrhosis, loss of liver function, but also TACE will induce liver damage. In this slide, the graph depicts liver function or deterioration of liver function after the first TACE treatment.
This is, this is something that has become increasingly clear in the discussions with our, with our experts, that what they would really would like to see is local regional treatment to control the tumor in the liver, without having excessive risk of damaging liver function. If we move to the next slide, this is a slide that, that we've shown before, but just to highlight what, what we think are the important aspects of Fostrox, is that by an oral treatment, we do have a liver-directed, local regional effect on the tumor. It is very, very much linked to the proliferation, the growth of the tumor, and very selectively hits the tumor.
On the right side, the graph is from, from biopsies from, from patients, where we have looked at the result of, of fostrox treatment, that is the DNA damage that, that will kill the cells, both in, in the tumor tissue itself, but also in the adjacent nearby normal liver tissue. And as, as our preclinical work indicates, we, we do not have induction of, of a DNA damaging effect in the surrounding liver tissue, which means that, that I, I believe that this, this would be something that, that really would interest clinicians in, in the context of not damaging the normal liver function, but selectively inhibiting growth of the, the tumor in the liver. With that, I will move over to, to Jens's conclusion.
Thank you, Fredrik. As many of you know, but just to highlight that Medivir does have we do have a long history of developing drugs to target or reach the liver. We truly believe, and then we are unique from a mechanism of action in this field with regards to liver cancer, and we truly believe that we have found a way, which we are now encouraged by the, the clinical signs we're seeing, find a way of having patients benefit from a liver-targeted sort of cytotoxic drug, while minimizing the, any damage to, to liver function. As we then, sort of as we're seeing this, from a data perspective, of course, we look ahead. In terms of looking ahead, we have communicated that sort of, we have chosen Fostrox plus Lenvima as the arm for second line.
What we're looking to, from a, from a next step perspective with that arm, is clearly then to compare with, to do a randomized study. What we are, are working with our Scientific Advisory Council, is to sort of design the best possible way forward or program study in that sort of second line space, looking at Fostrox Lenvima versus Lenvima mono, as it's showing clinical promise and as it's sort of aligning super nicely with the treatment algorithm.
I as, as you may remember, sort of I did comment that sort of the Keytruda arm is still of importance, and having a dose, having the ability to combine with an immune therapy is still important, and we think there is a good rationale for doing so with Fostrox, just not with Keytruda in second line, because it's, it's not logical to use it after Tecentriq Avastin. However, combining with an immune therapy and possibly a TKI or VEGF inhibitor, could definitely be an interesting option as a triple combination in first line.
That's something that we are exploring, and we're looking at it with the advisory council and seeing what could be a potential way forward, would probably be a single-arm study design that would also then sort of align very nicely with the, the, the treatment algorithm first line. Those are the, the, the, the working, sort of what we are working towards. I referenced the treatment algorithm a couple of times, but just then to go back to, to this slide again, where we, we started it a little bit, that sort of clearly in that first line setting, a triple on top of Tecentriq Avastin would be logical.
Sort of as a first step to, to take the, the clinical benefits and, and the encouraging signs we're seeing in second-line in, in that second-line space and combining with Lenvima, in order to bring a liver-targeted drug to the market as fast as possible. I mentioned before, and we've communicated that sort of externally, the advisory council that we are working with to sort of shape the future development, Dr. Reig, Heo, and, and Evans are, are all three part of our current program, whereas Dr. Finn and, and Vogel are not, but they are sort of world-renowned experts in the field, and Dr. Finn have been the primary investigator on a number of the most important sort of landmark studies in HCC as of late.
With that said, before handing over to Magnus, if I just sort of sum things up, hopefully, we have shown that there is a significant unmet need, in general, but also specifically for a liver-targeted compound, to minimize the, the primary tumor burden in the liver. With that clearly comes a, a significant commercial potential. We do have a unique mechanism of action. We are the only liver-targeted compound that then selectively targets cancer in the liver. There is a strong potential for attractive combinations, and we're super encouraged by what we're seeing in the Phase IIa in combination with Lenvima as a start. With that, Magnus, financials?
Thank you, Jan. If you can move to page 26.
Yes.
Where you can see the financial summary for Q2, and year to date, to you.
which I will briefly comment on. From a financial viewpoint, Q2 was, according to our plan, with no, no really big surprises. The turnover for 2 months, SEK 2 million, which relates to royalty income for Xerclear which was higher than last year. Other expenses are higher as well compared to last year, and they almost relate to the costs for the ongoing combination study, which was a bit higher in this quarter. Year to date, we can see the costs are lower, and that's actually almost due to lower clinical costs, and especially for Q1. Personal costs are higher, and relates almost that we have more employees, at, at the time compared to last year, and the same applies to them to year to date, of course.
The operating loss for Q2 is minus SEK 27, which is higher than last year in the quarter, but if you look at year to date, it's below last year. It's in line with our current plans, no surprises. Year to date, the operating cash flow is minus SEK 34, which is much lower than last year. The quarter was in minus SEK 18 in the quarter, which was more or less in line with same level as last year. If I sum up the cash balance at the end of Q2 is around SEK 83 million. According to our current plan and with our current assumptions, the cash run rate is into Q2 2024, which is in line with what we have communicated before. No change there.
With that, I will hand back over to you.
Thank you, Magnus. Then final slide before we go into Q&A, just to sort of repeat back what we said at the beginning. There's three elements to... I would pull out today. One, there is a very strong momentum in the lead program with regards to moving forward. There's a continued very strong interest among investigators and patients to participate. Perhaps most importantly, we are seeing very promising signs of clinical benefit in the Fostrox Lenvima arm, as communicated earlier this week, and as we have highlighted in a bit more detail here today. Excited about where we are and the as we sort of plan ahead with the lead program Fostrox. With that said, we will stop, and we'll move to Q&A.
If you wish to ask a question, please dial star 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star 5 again on your telephone keypad. The next question comes from Richard Romanus from Redeye. Please go ahead.
Hi, hi, guys. Good afternoon. I'd like to start with some questions about financing. So you, you mentioned in the report that the board of management makes assessment that there are good conditions to carry out the financing within 12 months. I just, just wondered whether you're considering accessing the capital markets to just to finance continued operations, like, like a bridge financing, or if you as a first, first step, or would you do a financing also for the Phase II, 2B trial at the same, same time, or, or? Also, I guess you would, would, would want to wait for the readout from the Lenvima before to do, doing a financing.
Yeah. Thank you, Richard, for the question. Magnus here. Yes, I mean, we explore different alternatives for the financing and, and, and as we have not communicated this, we have not made a formal decision yet on, on when and, and how the financing will look like. As you said, of course, it would be nice to, to align it with the readout from the Lenvima arm. That's why we, we and as we have mentioned during this call, I mean, the patients are still on treatment, and, and we are gathering data all along, and, and we have included 15 patients now, but, but we, we have to wait and see when we get the data as well. No decision yet, but we are exploring different alternatives for the future.
And we will communicate it when we have decided on that. I hope that answers your question, Richard.
Yeah. Yeah, I had a related questions, because situations would be quite different if you find a partner, for example, an Asian partner, who could finance the Phase II trial.
Yes, you are definitely.
I guess, that will mean you would need to raise less money than if you would have to do a Phase II trial by yourself, or would you? I was also thinking whether it's even possible to finance a large Phase II trial in this, in current financial situation. Wouldn't you be dependent on finding at least one partner to do, let's say, take half the costs of an upcoming Phase II trial?
Yeah, I mean, definitely you are correct. If, if we could get financed with, with a partner, that would, of course, help us for the next financing. As I've said before, I mean, we're looking at different alternatives at the moment, and that one is, of course, something that we're exploring further on.
Okay. Last scientific question, first, when, when could we have... You think we could have figure a median progression-free survival? You also mentioned that scans are taking six weeks apart. Does that mean that you, you either, you either, or this number has to be multiple of six weeks, three months or four and a half months or eight, eight months? Or no, sorry, six months.
For each individual patient, normally, the scans will be, if they are according to the schedule, every six weeks. Of course.
Mm-hmm.
the median progression-free survival or time to progression, et cetera, in this study, would not have to be exactly in 6 weeks intervals, because of obviously it would be an average, over the patient population.
if it's patient number H, isn't that the median patient? That should be an even number.
Yes. But still, you would need to take a look at there are also going to be, most likely, and have been unscheduled, scans, in the study.
Okay.
That requires that, that everyone will be, exactly, just having scans, on the six-week, date.
Yeah. Okay, I got it. If we assume then, that the progression-free survival based on, on patients recruited, that thus far seems to be something like five months, perhaps four and a half months. Shouldn't that... Those patients would probably or you need to have a reader from all the, all patients, including the last 5, because that... If you would calculate forward four or five months, could that be in January then?
I wouldn't want to give you a, a specific date. Obviously, it's sort of a, a balance here, where, the better the, the, the treatment effect or the benefit is, the longer the study will be. We will see. I mean, the, the last patients in, they have not reached that number of, of scans yet. We'll have to let the data speak for itself.
Do you think... I'm sorry. Go, go ahead.
No. I, I couldn't give you an exact date.
This, this year or, or early next year, what do you think?
Yeah, it's difficult to say. I would assume that we would have data this year to be able to present the preliminary data in the beginning of next year. That said, it will be depending on how the study goes.
Yeah, of course, the, the longer, the later, the better.
I mean that, that's a little bit... If we sound a bit wobbly here, Richard, that's because the longer, the better, and, and clearly with regards to patient benefit in terms of sort of what the drug and the combination is, is doing, so the longer, the better. Then, then there's also the element of, of, well, data is important as we start to plan for the next Phase, et cetera. But, but with that said, difficult to give an, an estimate. And, again, and especially considering that we, we are quite encouraged by what we are seeing in the study as we speak, as we are, have, have hopefully been able to convey a little bit.
That encouraged data set is sort of clearly pointing to, okay, we're, we're not going to have the, the data matured tomorrow or, or in the, in the next months. It will, it will take slightly longer than that to mature just because of the benefits we're seeing in patients.
Yeah, I got it. Thanks, thanks for the, the answers.
Yeah. I think the other comment just to make, Richard, is that now we, we hone in on, on PFS or potentially Time to Progression. We are, sort of clearly, the Overall Response Rate is something that we will see, is something that we can read out quicker than that. We'll see data sort of earlier than that. There are different sort of end points as well.
Okay. Okay, thanks.
Thank you.
The next question comes from Klas Palin, from Erik Penser Bank. Please go ahead.
Yes, hello, and thanks for taking my questions. Nice to see promising data from the Phase II study so far. Just if you could... Help me out with to clarify. As the data you report about this female Caucasian, 56-year-old.
Yes.
With hepatitis C. You say that, you see a tumor shrinkage of 30%, but you still don't define it as a partial response. If you just could clarify?
Maybe we are being overly cautious on this, Klas. The primary readout of the study is central. From a local read perspective, it is more than 30% tumor shrinkage. As we say, sustained, so it's actually over more than one scan. This particular patient actually had sort of stable disease for the first three scans, and then we saw a response from scan four and onwards.
Mm-hmm.
From a local read perspective, it is a partial response.
Mm-hmm.
We just -- we're just being a bit cautious in not calling it a partial response on the, on the slide, because there will also be a central read. Maybe we are being overly cautious, but yes, it is a sustained shrinkage of more than 30%, and by definition then, yeah, that is a partial response.
Sounds good. Another question for clarification, perhaps. It's slide 15 where you are referring to second-line data. I guess this is second-line data after a TKI, like Nexavar or something like that.
Yes. Yes, it is.
Have you-
Say that again?
Have you seen any data, second line after Avastin and Avastin?
The short answer is also yes. So then now, Pia is listening in on the call. Now she's thinking, "Yeah, you should have been clearer on this slide." And I should have. Well, thank you for calling that out. I will actually take the opportunity of moving to slide 15 for the sake of the argument. What you're seeing on the left-hand side are 5 studies. 4 of them are post-TKI first-line, and that's with Stivarga, Cabometyx, Cyramza, and the combination at the bottom. That's an important element, as you say, 'cause there are very few studies where we actually know what happens after Tecentriq Avastin.
The only sort of data that we've been able, that we think is sort of good enough to, sort of represent, is actually the Lenvima data you see on this slide.
Mm-hmm.
The Lenvima data here, it's not a randomized prospective study. It's a retrospective data set from the U.S., I believe, where they have measured Progression-Free Survival. These patients, they got Lenvima monotherapy, second-line after Tecentriq Avastin. The interesting part is that median Progression-Free Survival in that data set aligns sort of with the others, i.e., it does signal it is a challenging patient group to treat sort of post Tecentriq Avastin as well. Clearly, it's a retrospective data set, so it's, it's not as sort of robust, but it, it aligns with the others. They did not measure Overall Response Rate in that population, and that's why it says not available on the right-hand side. It is, so Pia usually calls it a data desert when it comes to second-line population post Atezolbev.
we are kind of breaking new ground or trailblazing a bit with regards to sort of running this study and, and, and looking at sort of data or efficacy in this population.
sounds good. Then my last question would be about business development. Are you increasing your efforts to find a partner when you have this data, or the data are starting to mature?
There are two answers to that question. The short answer is yes. The slightly longer answer is clearly, sort of I mean, we've had sort of efforts ongoing or sort of we, we, we continue to speak with, and it's been super clear that sort of, let's start to generate clinical data, in, in that second line space. Now that we are, and since there's an open label study and we can follow the maturing of the data kind of continuously, that clearly opens the door for engaging sort of in more detailed discussions. Yes, it's definitely... I mean, that, that's the other exciting part about sort of generating the data, is that it, it does open the door for discussions, because that's what, what a potential partner wants to see.
Perfect. That was all for me for now. Thank you for taking my questions.
Thank you, Klas.
As a reminder, if you wish to ask a question, please dial star five on your telephone keypad. There are no more questions at this time, I hand the conference back to the speakers for any closing comments.
we will, in addition to leaving you with sort of the, the, sort of the, the, the excitement that we have hopefully been able to convey, regarding sort of where we are with the program and what we see looking forward, with some upcoming activities, going forward. we will have a number of presentations at sort of healthcare conferences in, in the coming sort of few weeks and a month. we will also be sharing some non-clinical data at the ILCA Congress in Amsterdam on September 7th through 9th. We'll share a bit more detail about that later.
Perhaps then, most importantly, what we're also planning to do, on the back of sort of encouraging sort of data we're seeing and as we are planning ahead, we are sort of planning to host an expert perspectives webcast together with KOL experts in our Scientific Advisory Council on the sort of current unmet medical need and the future treatment landscape in terms of the importance of liver-targeted sort of treatments in the field of HCC. That we're planning to hold. The current planning assumption is that we'll hold it at the webcast at the, the ILCA Congress, and, and, and sort of broadcast it out for, for everyone to attend wherever they are in the world.
We do have the council sort of gathered at the congress for other activities, so we will look to take advantage of that and maybe hold an hour session or so. More details on that, exactly when it happens and login details, we will of course, communicate in advance before that. With that, thank you all for dialing in and logging in on a Friday afternoon. Hopefully you share our excitement about where we are and where we're moving to. With that, thank you and have a great weekend.