Welcome to Medivir press conference. 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 pound key five on their telephone keypad. Now, I will hand the conference over to CEO Jens Lindberg. Please go ahead.
Thank you. Good afternoon, and welcome everyone. My name is Jens Lindberg. I am the CEO of Medivir. I am joined for today's call by our Chief Medical Officer, Pia Baumann, as well as our Chief Scientific Officer, Fredrik Öberg, and Magnus Christensen, our CFO. Today's call, we will follow up on the events at last week, when we presented our first data for fostrox plus LENVIMA at a scientific congress at ASCO GI in San Francisco, and go through the data and also what that means, implications for our plans going forward. So we are now back in Sweden after a very energizing week, with a lot of interactions with global experts in the field of hepatocellular carcinoma. And in the call today, we will focus on three elements.
We'll start off with a bit of a sort of top-line takeaways that we are coming away with from the conference. Then we will spend most of the time going through the data that we presented for fostrox plus LENVIMA in the ongoing study that was presented by Dr. Maria Reig at the ASCO GI, plus some sort of additional sort of analysis and update that we have done, with regards to median time to progression. But we will come back to that, or Pia will come back to that in more detail. And as mentioned, we had extensive one-to-one interactions with global experts, sort of going through the data, the sort of fostrox program, and the plans going forward to gain input and feedback on our plans.
That will be incorporated as we are moving forward, and Pia will talk a bit about sort of those discussions and, and the reflections, and how that sort of helps influence our plans going forward. But before we then go into sort of more detail, the three things that we did as a team at ASCO GI was that sort of first data presentation at a scientific congress, a lot of expert engagement to gain advice regarding the fostrox development, and then, as I mentioned, insight sessions, both with the members of our scientific advisory council, but even more so reaching out to experts and potential investigators with regards to the upcoming phase II-B study. So engaging with experts across the different, sort of, different markets and regions in the world.
And top line, what we take away are a few things, and it's very clear that there has been a substantial development in the first line space with regards to advanced HCC. Whereas the second-line population is not at all in the same focus. And there has been, with regards to data, mainly sort of first-line data, both at the congress and at previous sort of events, different types of IO combinations together with new regimens in earlier stage HCC, whereas it continues to be quite limited second-line data presented. And the data that has been presented does confirm, so if we focus on implications for fostrox, the limited second-line data that has been presented does confirm previous efficacy benchmarks in terms of what you can expect to see in that population.
There continues to be a lack of development from other companies in second line, and feedback was very clear from the physicians we met with that sort of the plan fostrox LENVIMA study does fill a very clear research gap in second line. And there was for many of the physicians or the physicians that we met for the first time, that was exposed to fostrox, the compound and the sort of the data, et c., we got positive response both on the mechanism, but also in terms of the data and plans going forward with regards to study design, et c. So overall, a very good congress with a lot of fruitful, valuable interactions.
But as mentioned, we will focus today primarily on the data that was presented at the congress, and to do that, I hand over to Pia.
Thank you, Jens. And as Jens said, the first data from the phase I-B/II-B study with fostrox plus LENVIMA was presented at ASCO GI by Dr. Maria Reig. You can go to the next slide, please. So just a little bit of a background, and this was also something that was discussed there at ASCO GI, is that fostrox is a type of smart chemotherapy that is liver-directed. And this is really, really important because chemotherapy was, and is, still a major component of cancer treatment. Either as monotherapy, but these days, often as a backbone of different combination with, for example, targeted therapies or immuno-oncology. However, in some cancer forms, as HCC or primary liver cancer, it has been impossible to deliver doses that is high enough with standard chemotherapy to get an effective tumor-killing effect without causing intolerable side effects.
But with fostrox, doses that are high enough to be effective is possible due to that it is this liver-targeted mechanism. It is an oral formulation, it is a pill, but after you swallow it, it is stable in the GI tract, and it gets directly delivered to the liver. And there, in the liver, the drug is activated by enzymes. With this mechanism, the hundredfold higher liver exposure of the active drug is achieved, and this is compared to what standard intravenous chemo can do. So, the study presented here at ASCO GI had a dose-finding part and an expansion part with a combination of fostrox 30 mg. That was the selected phase II dose, for five days in a 21-day cycle. And LENVIMA was given at a standard daily dose that is approved for HCC.
It was 15 sites in the U.K., Spain, and South Korea that enrolled patients, and efficacy assessment was made both by CT scan and MRI every six weeks. Twenty patients were evaluated, with a mean age of 63 years, and the majority were men who all had liver function Child-Pugh A. When it comes to etiologies, 75% were virus, 70% had metastasis outside the liver, and 85% had a prior treatment of what is considered standard of care, meaning, TECENTRIQ-Avastin. The majority had one prior line of treatment, but 15% had actually two prior line of treatment, and all had progressed on that prior treatment. We can go to the next slide.
Is it worth a sort of question, Pia? It's 20 patients versus the total 21 in the study in terms of commenting sort of why it's 20 in the presentation here.
So, the 20 patients is because we could do a central review in September of 20 patients who had been assessed at the CT and MRI scan more than twice. So it's a confirmed efficacy event.
Then we move to the next slide.
So, the patients with HCC have often a relatively low tolerance for side effects because more than 80% of the patients have a relatively malfunctioning cirrhotic liver, and it is important therefore to control and reduce the tumor, particularly in the liver. This is to preserve as much liver function as possible. So, with that said, a tumor treatment for HCC cannot be toxic to the liver, and it needs also to be tolerable overall. So, we did the monotherapy study that was presented in 2021, and saw that fostrox was tolerable, and we did not report liver toxicity there. And the most common side effects were neutropenia or low blood white blood cell count or thrombocytopenia with low platelet count.
Why we saw this is that this is an effect of the fact that some, even if it's liver targeted, some of the drug is leaking out from the liver due to the fact that these patients have a cirrhotic liver. This means that the incidence and magnitude cannot be compared to the hematological effect that you see and you expect with standard chemo, because there the compound is given directly intravenously into the bloodstream. So, we did see that the patients in the combination also had non-febrile neutropenia and thrombocytopenia without any bleeding incidents in the combination trial. It was the most common side effect. And the fact that it was transient and temporary made it very manageable, with 70% of the patients keeping the dosing schedule that was for fostrox without any dose modification.
Only 5% actually discontinued fostrox due to side effects, and we didn't see any new unexpected safety effect when we combined it with LENVIMA. And this is really, really important, because LENVIMA, we shouldn't affect the, the efficacy of LENVIMA. So, what we could also see that the need for dose reduction of LENVIMA was not increased compared with what is seen with LENVIMA monotherapy, and the side effect with LENVIMA was as expected from monotherapy. Also important is that we didn't have any death or Grade 5 adverse event occurring. Can you go to the next slide? So, fostrox and LENVIMA showed really promising efficacy with the best response of 30%, with one complete response and five partial responses, with the centrally reviewed mRECIST, the modified RECIST, and that is the solid box that you see here.
This is confirmed, but with higher magnitude, with mRECIST, with what is seen with RECIST 1.1, which, which is the checkered bar here. We also looked at locally assessed RECIST 1.1, a response rate there were 25% with five partial responses. And just to make a note, in some patients with good response in the target lesion, you could see progression, progression elsewhere, which is the case with patient number 17, if you look to the right. This patient had an almost complete reduction of the target lesion, but progressed rapidly elsewhere, and was found later on to have a transformed HCC because they are more aggressive form, a sarcomatoid 4. So, even if it was a good response in the target lesion, it was progressing outside. That is why it looks like it looks.
Can we go to the next slide? So this waterfall plot with the locally reviewed efficacy data is showing again an encouraging clinical benefit. And we can see that the treatment in some patients have done that, they have been able to stay on treatment for a long period of time with sustained response, and that is the two patients on top here. And we still have more than 40% of the patients ongoing in the study. And currently, we have a median time to progression, and this is January second, where this data is from, and the time to progression at this time point is 5.1 months. Again, with an overall response rate of 25% and a disease control rate at 18 weeks of 61%.
And again, as visible with the patient on top there, the target lesion seems to be continuously to shrink over time. And when they have a response, it is sustained also with a longer follow-up, as long as we have today. We can go to the next slide. So the conclusion from the presentation at ASCO was that we saw an acceptable safety and tolerability profile, and we had an encouraging efficacy outcome in these patients. The disease control rate was high and durable in this patient population, with 61% still having clinical benefit at 18 weeks. And based on this result, as Jens already mentioned, we are planning to do a randomized phase II study to further evaluate the clinical benefit. We can go to the next slide.
We showed you this data that you have seen here, and it is clear that combination with fostrox, LENVIMA have, in this study, shown good tolerability, with that the patients actually are able to stay on the treatment little longer than actually we expected. And we have seen improved clinical benefit when we are analyzing the data, and this can be seen over time. If you look at this slide, you can see that from 17% response in October, we are now at 25% response in January, and we have an increase in time to progression from 4.5-5.1 months.
So I guess it's I mean, we are looking all the time that how does this efficacy data really compare with what is seen in second line after what is used in first line as a standard of care in immuno-oncology combination? And also why are we so encouraged by our data? So at ASCO GI, we can go to the next slide. There was an independent symposium summarizing the current evidence on using sequential treatments in HCC, and also what treatment regimens are used today. And this is important, right? Because it was not that long time ago, there were no treatments for second-line HCC because they had a very poor outcome. But now we see that this is increasing, but yet still unmet need. Can we go to the next slide?
So as previously said, IO combinations or TECENTRIQ-Avastin, it is the preferred treatment regimen in the first-line setting. And there is really no consensus in the best treatment in second line. Even if majority, and we have sort of had this confirmed also in the discussion at ASCO GI, several experts is to use LENVIMA due to the superior efficacy that has been seen in the first line setting. But this newly published lenvatinib data that you see here on this slide, where patients had progressed on TECENTRIQ-Avastin, shows a PFS of 3.7 months and an overall survival of 12.8 months, very much confirming our assumptions for our future clinical trials.
There are other alternatives, obviously, also in the second-line setting, as you can see, a cabozantinib, but has inferior outcome. We can go to the next slide. So, there are studies ongoing also with IO combination in the second-line setting, even if they get IO in the first-line setting. But so far, the progression-free survival of 2.2 months here and an overall survival of 7.4 months has been disappointing. So, but nevertheless, there are no strong evidence for what you should select post an IO combination treatment, and clinical studies here are really wanted, and that is also something that we learn in all our communications. So we can go to the next slide. So we have benchmarked, and I think we have shown something similar earlier, but now we have more information available.
We have benchmarked the data seen with fostrox plus LENVIMA in this ongoing phase I- B/II-B study, with what we see historically in second line and the limited clinical data set that is available. Our data compares favorably with those, with an overall response rate of 25%, disease control rate 79%, and a time to progression of 5.1 months. And this is again, the data that we have from 2nd of January. You can go to the next slide. So with three more weeks of follow-up, so from the 2nd January to the 22nd of January, in the same study, further improvements in TTP has actually been shown, and it is now 5.8 months.
We also wanted to understand if clinical benefit from a prior treatment influenced who would benefit from fostrox plus LENVIMA in the second line. So we did an analysis where we compared the duration of treatment in current study, that you see here to the right, with the duration of previous treatment. You can go to the next. And it showed no real correlation, and patients with short duration on prior treatment could have longer benefit with fostrox plus LENVIMA, as you can see, on the patients on top here. And this is really, really important because we shouldn't exclude patients that haven't responded bad on first-line treatment. They can have a benefit, and particularly, if you switch to a different mechanism of action, that might be the case here.
And again, a need for a study with a new treatment strategy, which is applied with fostrox, is really needed. So you can go to the next slide. So based on the high unmet need and the encouraging safety and efficacy data that we have seen, now we are about to finalize the planning for the next phase study. You can go to the next slide. So, this study is a randomized, double-blind, phase II-B study with fostrox plus LENVIMA versus LENVIMA plus placebo in patients in advanced HCC patients that have progressed on one prior IO combination. And we received really important and positive feedback from the global expert. You can maybe click on that at ASCO GI, and there was a strong support for the study design overall, and confirmation that LENVIMA was the preferred second-line option. Because that is important, right?
If we combine with something that's not going to be used in second line, then this study is not going to be successful. We received also confirmation of LENVIMA estimated efficacy data and what would be a meaningful clinical benefit and what endpoint that could be used to measure it. And as you can see here, we have used progression-free survival, and that seems to be a reasonable endpoint for this measure. So and overall, the patients, I can't see the slide. So and, it's really, really important to have this information because we are going into discussion with the FDA and to understand sort of what the experts are seeing about the clinical study design, it will help us to value, the most important question and also confirmation that our thinking has been correct.
Thank you, Pia. So in terms then of as we've communicated before, we are sort of in, we've accelerated our development program, sort of, as we have been encouraged by the data, and it was sort of really, well, really sort of positive interactions at ASCO GI, sort of confirming sort of our positive take on the data. So we've been sort of, kind of, reinforced in our belief in terms of moving forward with speed and, sort of aiming for a registrational study that could have accelerated approval intent. So we continue to accelerate the program, and what we're looking sort of here and now, and sort of in the short term moving forward, sort of acceleration activities are centered around three categories. There's the CMC or manufacturing elements.
We've communicated in Q4 last year that sort of we have an updated commercial formulation that is ready for production to be included in the pivotal phase II-B. That's a super important step to take. So if we are running a registrational study, it needs to be with the final commercial formulation that's in place. We also have a process development suitable for commercial manufacture, equally important, also announced in Q4 last year. And we have initiated sort of manufacture of a new GMP campaign, sort of as we are sizing up the study for registrational intent. So those were some of the critical elements within the CMC field.
Equally, moving forward with the clinical engagement, as Pia sort of mentioned, we do have our scientific advisory council, which we are meeting on a regular basis, engaged with ASCO GI, so that's ongoing, but in sort of here and now, it was very important to have extensive sort of interactions with new KOLs and potential new investigators at ASCO GI, and that will also happen at the EASL Liver Cancer Summit, which takes place in Rotterdam in February. And of course, planning for a registrational intent study, sort of that takes a little bit of time, so you need to start early. So the CRO selection process has also been initiated, and is also something that we've engaged with potential CROs sort of as we were traveling to San Francisco.
And then, finally, there's the regulatory category. We've communicated previously the FDA Type D Meeting that we had to confirm elements of the study design, positive feedback. But more importantly, we have initiated the process for an FDA Type C Meeting. So that will be an important sort of meeting and engagement to confirm the study design, and that's also why the interactions around the study design were so important with the KOL community. As part of the regulatory discussions with FDA, then we're looking to open an IND and apply for Fast Track Designation.
But sort of overall, with the acceleration activities, I think the key message is that we are well on track with all the activities that we have set out in order to move forward to initiate a pivotal study sort of as soon as possible. And the aim, as we've communicated previously, is an accelerated approval by end of 2027. And just to sort of sum things up, because the other element is that that is also equally important looking ahead, is what does the market look like? Have we assessed the market correctly? Have we assessed the potential correctly? And again, the ASCO GI interactions did reinforce our previous estimates. One element being there is not a lot of development going on in second line.
That opportunity to become first to market is clearly there, and we are getting very strong steer from the KOLs that there is a big need here, and they are urging us to move with as much speed as we possibly can. And by 2028, this market will be worth $2.5 billion annually, with potentially no competitor, no approved competitor in this space, for a significant opportunity from a fostrox perspective. So to sum things up before we open up for questions, fostrox is a, and that's as Pia alluded to earlier, super important. It is a smart chemotherapy. It's a targeted, a liver-targeted chemotherapy, that does have tumor selective, efficacy in the liver, with the potential for accelerated approval by sort of end of 2027.
We are seeing that the combination is showing clinical benefit, and that clinical benefit continues to improve as study matures, as Pia showed, sort of as patients are able to stay on treatment long term. And we are also seeing, when look at sort of historical benchmarks, efficacy benchmarks, that the combination does compare quite favorably versus what can be expected from LENVIMA alone. We continue accelerated development in second line, and our interactions did confirm the value and the sizable value of the market at the $2.5 billion annually by 2028. So with that, we stop there and we open up for questions.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Joe Pantginis from H.C. Wainwright. Please go ahead.
Hi, everybody. Good morning, good afternoon. Thank you for the very nice update, very encouraging data. Hopefully, I'm looking forward to the next steps here. So I have a few questions, if you don't mind. So first, you gave the impression coming out of ASCO GI with all of your discussions with clinicians, it seems there's a bit of continuum, as you mentioned, you know, people that are familiar with fostrox already and people that have been introduced. So I guess I wanted to sort of gauge, you know, where does it stand of the clinicians, understanding and the MOA of liver targeting fostrox resonate with the physicians and people that are newly introduced?
Joe, I do apologize. Probably something at our end from a technical perspective, so we lost a big chunk in the middle of your question. So could I bother you to ask it again?
No problem. No problem. I'll try.
I apologize.
That's fine. I, I guess I wanted to get a sense, like you said, you had, a continuum of people that, at our clinicians at ASCO GI, that were familiar with fostrox and also people that were newly introduced to the drug. How do you feel the mechanism of action with regard to liver targeting is resonating with the new introductions?
Well, thank you for that question, Joe, and I think that it is really important for us to explain it in a way so everyone understand the mechanism of action, because that comes back when talking about the efficacy. So, I think that the mechanism of action, when you understand that it is not a standard chemo, it is a chemo that is liver-directed, and is activated in the liver. When we explain it in a thorough and a little bit comparing way, when we also talk about how ADCs or antibody-drug conjugate works, which actually has a warhead with chemotherapy that is targeted to a receptor. This is targeted to the liver instead, and is activated.
I think that with that more in-depth explanation, there is also an interest, particularly since this is another mechanism of action, and that is needed in the second line setting.
I think it's fair to say, without going into specific KOLs, but that there were a few instances where sort of in the beginning, sort of if there was a perception that, okay, so this is a chemo, and there was maybe an assumption this is a standard chemo, the KOL was maybe leaning back and maybe not sort of as interested. But so the, when we got to the targeted point and the kind of the pin dropped on this being a quite different mechanism, then the interest switched immediately, and the person started leaning forward and started engaging much more. So the minute, as Pia said, you could kind of.
Mm.
You see it in the body language, and you see it in their eyes, that sort of moving from standard chemotherapy to ooh, targeted, and to when targeted to the liver, made a world of difference. So I think that one of the key elements for us is how can we, how can we communicate that in the simplest and clearest possible fashion?
No, that, that's very helpful. And I guess my next couple questions, if you don't mind, and thanks for bearing with me, is, are a forward-looking question. So with regard to the phase II-B, you know, pretty straightforward design here, wanted to, I guess, discuss your optionality in bringing the study to fruition, and I guess combination of potential business development, other non-dilutive support, say, from oncology groups versus cash on hand. How are you viewing the, you know, looking to complete the study right now?
I think what I mean, the one thing we have communicated sort of relatively, sort of clearly in the past is that we are an important element for us is to. We're looking to establish sort of industrial partnership with primary focus on Asia, but, but we are open to, to have alternative discussions as well, depending on partners. I think our, our preferred sort of option moving forward is to establish a partnership, i.e., to identify a development and commercialization partner, to have a. We will run the study, we will move it forward, but to have a partnership with someone coming on board in terms of both sort of, I don't know, technical support, but more importantly, financial support as well.
I think that's, that's our preferred option going forward with regards to kind of, from a, from a financial point of view.
And I can add also.
Got it.
With the consortium, obviously, always interesting, but again, we just started reaching out, and particularly in the U.S.
Okay. No, that's great. And then I'll just combine my two last questions because they're both logistics surrounding the study. So first, as you're going into your next FDA meeting to discuss the final design, how confident are you that the primary endpoint could be PFS? What other sort of discussions are you having? What do you think is like the most relevant, outstanding question? And secondly, obviously, you said you have the new formulation. Where do you stand in capacity now to be able to be ready for the study? Thank you.
So let's start with the PFS. So, PFS includes also patients who have a stable disease, which is considered more or less response or at least clinical benefits in HCC. The response rate in second line is really, really low. It's somewhere around 10%, some say 5% even. So which means that in order to have a study that really shows what clinical difference or clinical benefit differences is, we have selected PFS. PFS is a surrogate endpoint for overall survival, which we need to have in a confirmatory phase III, but overall response rate is often used. But again, in this case, I think that we are relatively, we need to talk to the FDA first, but, we are confident with PFS as an endpoint as it is right now.
It is. I can't stress that enough, that sort of everyone we speak with on this, especially in second line, they are very clear that don't underestimate the value for patients and us physicians, of course, but for patients, of just stable disease and being able to sort of break the cycle if someone has sort of progressed on previous treatment, and you stop that sort of tumor growing, and you have a stable, even shrinkage. So that is an important clinical benefit, and as Pia said, PFS captures that, whereas overall response rate doesn't. With regards to the CMC updated commercial, sort of, sort of has updated, formulation, et c. Here we are sort of well. Now, I'm looking for a word, sort of, we're sort of.
Well on the way.
We are well on track now. We are well placed. Sort of, we're not seeing any challenges with regards to ramping up, and having enough material ready by the time study is to initiate. And that is why these two elements, we're working with Lonza and Quotient, which we communicated in our press releases. That's why we, it was so important after our Q3 call, to start off with those activities directly, because they were on the kind of critical path. But since we were able to get those up and running so quickly, we are on that one, we're quite confident.
Great. Thank you so much for the details, and looking forward to the study start. Thanks a lot.
Thank you.
The next question comes from Klas Palin from Carnegie. Please go ahead. Klas Palin, Carnegie, your line is now unmuted. Please go ahead.
Hi there, thanks for taking my questions. My first question is related to the pivotal phase II- B trial and the primary endpoint. You have sort of indicated that the LENVIMA arm could have a sort of PFS of four months. It would be interesting to hear your thoughts about what you would be targeting in your design for the fostrox combination trial when it comes to PFS.
So thank you for that question, and this is a key question, really, and this is something that we have asked each and everyone to better understand if our assumption is valid or not. When it comes to sort of the use of LENVIMA as a second-line treatment, they all have experience, and they prefer to use LENVIMA, even if clinical trial is more needed. But they cannot really refer to any clinical data because they have none. So what they have talked about is more or less, more or less the reference we already have. It is this Japanese study with no clinical data on PFS 2.8-4.1 months. It is retrospective data that shows somewhere between 2.5-4 months.
I think that the assumption of four months has become more solid now than it was before.
Then he also asked, sort of, what's our assumption for benefit?
Oh, yeah. Our assumption for benefit is to have for it to be clinically interesting. We, this question we also ask, obviously, in two months, that would be interesting as a clinical benefit. But I must again say, when we talk with these experts, they have high expectation. They are often involved in first-line studies. In second line, I mean, coming back to this again, the benefit has not been that high with what is used in second line, which means that from four to six months, it is a reasonable jump, and I think that the majority, or I know that the majority think that that is enough for a clinical trial. Then it's up to the regulatory authorities, obviously, to see if this is relevant or not. So the study is actually.
It is.
Calculated on two-month difference.
It sort of, we didn't get, sort of, I mean, this one, we did push quite a bit in terms of really trying to tease out any.
Yes.
C lear objections on this, which we didn't get. So that was, that was a good outcome as well, with regards to kind of confirming our thinking, even though there is a lack of data in the space.
Okay, thank you. And just out of curiosity, when you have been speaking to physicians and key opinion leaders at ASCO GI, did you get any new insights about the possible design of the phase II-B trial?
So the insight, I would say the most important insight was the stratification factor in a trial like this, because this is a randomized trial where we really need to ensure that we have two arms that can be compared with each other, even if it's not so big, or I would say, because it's not so big, these factors are important. So one of the things that we saw, how much does, for example, macrovascular invasion and extrahepatic disease or etiology or a different liver function score, how much that influence actually your outcome, and how should that be stratified? So I think that was the main takeaway. The other was, yeah, they agreed with the study design, and most encouraging was that, they saw this study as exactly what they need in the second-line setting.
It was a high interest.
It's a little bit of a forgotten population.
Yeah.
Almost from a development perspective. And just to kind of build on what Pia said on the stratification factors, that's one of the reasons why we did the time to progression analysis, where we compared patient for patient in terms of the patients that responded on fostrox second line, and compared to how long it took for them to progress on first line, to see is there a correlation? Because there was a suggestion that maybe patients who progress quickly on first-line atezo/ bev should not be included because they are or that they don't respond to second line.
We can sort of in the data that we have, then we can clearly see that there are patients that do not respond well on atezo /bev, do have the opportunity to respond on second line, and some patients respond, have benefit for quite a long time.
Yeah, I could add to that, that this is what I have seen.
Okay.
With a treatment that has more or less the same mechanism of action.
Yeah.
You usually see that responding for the first TKI, you are not prone to respond to the next one. It was really, really encouraging to see that with the new mechanism of action, this didn't apply.
Okay, thank you so much.
Thank you.
The next question comes from Jason McCarthy from Maxim Group. Please go ahead.
Hey, guys. Sorry if I missed this earlier, but are you guys going forward with second-line for the phase II-B or potentially first-line?
So focus is on second line. So that's where. Because, well, with the fact that sort of that's where we have the current data, and that's where the big unmet need is and where the opportunity to be first to market is. So that will be our sort of planned entry point. We do see longer term, and that's also feedback we are getting from physicians, that a liver-targeted mechanism like fostrox has the potential to be combined with both TKI and IO, and then could definitely be generous, be valuable for patients in earlier lines. But sort of again, there is a clear lack of treatment options in second line, and that's where it makes the most sense to run a study with the LENVIMA combination. That's where we will sort of focus first.
Got it, thanks. And then I guess, could you just talk about the movement, as you just alluded to, of, of TECENTRIQ and Avastin to first line and, and what those responses look like?
So, TECENTRIQ-Avastin in first-line, is in first-line, and, the response rate there is, between 25% and 30%, in, in IMbrave150 study, that was the one that it was approved of. There is another approved, combination that is durvalumab and tremelimumab, the STRIDE regimen, and that is around 20%-25% in overall response rate. So that is what you see in the first-line setting. When it comes to, progression-free survival, the IMbrave had 6.8 months as a median progression-free survival. However, since there are, quite a few first-line studies ongoing, one is run by Roche. It's called MORPHEUS, where you add something to, TECENTRIQ-Avastin. There, they have not been able to come up to, to 6.8 months, actually.
The latest data we saw, the median progression for survival was more around 4.5 months. So, it is, I mean, with this in mind, this is the first-line treatment, and now the patients are going to the second line. Obviously, it is expected that the overall response rate should be a bit lower and also the median progression-free survival. But with a new mechanism of action, we don't really know, right? So there was a couple of data presented at ASCO GI as well, one with regorafenib, for example, after TECENTRIQ-Avastin, and they had a median progression-free survival of 3.5 months, if I remember. Or was it even lower? Yeah, I think it was 3.5 months, and a low overall response rate.
So this is, this is where we are, right? And again, second line, as Jens said, has been a little bit forgotten. So what is used there now is either they continue with an IO and add something like one of these TKI on top of it, or you use something that has been effective in the first line setting. So we are in a little bit in the data desert here.
And that's one of the, but as we are then seeing, now the data that we updated and presented at ASCO, when we are at sort of a 25% response rate, and now with the updated time to progression sort of this week, closing in almost on six months, they start to even look like sort of first line efficacy. And that's one of the reasons why we are encouraged sort of what, with what we are seeing in the second line space.
Got it, thanks. Then I guess lastly, you know, with the recent financing, are you guys sufficiently capitalized for the next study? And are there any ongoing partnering opportunities that could bring in non-dilutive funds?
The first question is no. So we're not funded for the full sort of phase II-B. The latest capital raise was done with the aim of ensuring that we could accelerate the development program and keep on track with regards to initiating a phase II-B by end of 2024 to generate that sort of accelerated approval by 2027. And a key aim going forward is to establish a partnership with the focus on Asia. That work is now that we intensified those efforts on the back of Q3 results when we communicated the intent to move into a pivotal sort of phase II-B.
We now feel that we have mature enough data to have those sort of partner discussions. So we are looking to bring in a partner, and one of the key aims with that is from a funding perspective, with regards to the phase II-B.
Got it. Thanks for taking the questions, guys.
As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
Thank you. And most importantly, thank you all for dialing in today to this call. We had a great week last week. Exciting to sort of present the data. Even more exciting with all the interactions, and engagement, and the feedback we got from the physicians, the clinicians, the KOLs, as we continue to accelerate. And of course, it's always sort of extra interesting sort of when you're able to go to a congress and present data, and that data is as encouraging as we believe that the fostrox data is.
We look forward to coming back with more data updates, but as Pia said before, we still have almost 50% of patients are still in the study, sort of with regards to and benefiting long-term, and the patient who has been longest on treatment is now at 17 months, and the one second longest has just passed 12 months as well. So patients are able to tolerate and benefit from treatment long term. So we look forward to come back with additional updates, and in the meantime, we will continue to accelerate the development program to, with the aim of, of making fostrox the first sort of approved treatment options after TECENTRIQ-Avastin, together with LENVIMA, of course. So with that, thank you all, and have a good rest of the day.