We are doing something no one else is doing. We are developing the first and only liver-targeted treatment for advanced liver cancer. On the back of quite encouraging early-stage data, we're now right in the process of moving on to the next phase. Let me talk about the journey we're on, what we have shown, and what we are about to do. We have recently announced sort of a fully guaranteed rights issue that actually the subscription period actually opens on Monday. It is a good time to hopefully listen. The purpose of that is to launch a randomized comparative phase II study, 80 patients, and I'll go into detail to confirm sort of the benefit that we're seeing in the early-stage data.
What we also see, and I will touch upon, is that sort of the design and the kind of positioning of the compound and the patients we're targeting, sort of we continue to see confirmation that sort of we've chosen a good path. There's actually a path to become the first approved treatment option in this particular patient population. What I will not touch upon today in detail is that we also work to out-license our other existing assets. And we just sort of signed a deal for one of those assets, which is remetinostat. We'll touch upon that in a sort of panel later today, but sort of encouraging sort of additional potential value upside as that sort of drug moves along, which is actually a phase III ready asset. Let's talk about liver cancer. This we know.
The question is, what does this have to do with liver cancer? That is that obese patients have a tendency, or to a very large degree, they get fatty liver disease. This is increasing rapidly as we speak. The scary part is that if you have fatty liver disease, the risk of developing advanced liver cancer is tremendous. These numbers are just going to go up sort of as we look ahead. That means that if I look at sort of the commercial opportunity in the area where we are playing, which is sort of second-line advanced liver cancer, this is going to grow quite tremendously over the next few years.
We're estimating that sort of conservatively, that market will be worth around $3 billion annually, likely to be bigger, again, on the back of the increases we see in the West when it comes to fatty liver disease. The exciting part from a commercial perspective, maybe not from a patient perspective, is that if we look at the treatment algorithm in advanced liver cancer, we know that sort of in that sort of first line space, all of those patients will get an immunotherapy combination that will provide benefit. They will eventually progress, and they will need a second line treatment. In that space, in second line, which we are targeting, there are actually no approved treatment options today. There are no sort of funded options for patients.
What clinicians do is that they use tyrosine kinase inhibitors that are approved in first line, but they're not approved in second line. They find ways to use them for some patients, and that's what they want to use, but it's not approved. What we are doing, we're developing our compound, Fostrox, in combination with a kinase inhibitor to be the first approved combination in that population. Fostrox is a liver-targeted drug. Basically what we've done, if you look on the left, we've taken a traditional chemotherapy, a nucleoside analog, which is the orange part, and then we've combined it with a prodrug tail or prodrug solution, which we in Medivir had a long history of doing in hepatitis. What it does is that it allows us to administrate the drug orally rather than intravenously.
It stays inactive as it goes through the system, and it reaches the liver via first-pass metabolism. It is not activated until it gets to the liver, but it is rapidly activated in the liver, trapped in cells in the liver, and then it starts to sort of kill replicating cells. What you see on the right-hand side, and that is the other sort of quite sort of, I would say, intelligent part of the solution, is that on the panel on the left, you see a lot of brown staining, and that basically means cell death. It kills tumor cells because tumor cells in the liver replicate relatively frequently, whereas healthy liver cells on the right divide maybe once per year.
Basically, the drug, when it gets activated, it kills tumor cells, but it spares healthy liver cells, minimizing sort of impact with regards to sort of side effects, et cetera. What we've seen, we've run a first phase 1b or phase 1b/2a study across three countries in the East and in the West. That was concluded in the beginning of the year. We presented final data. The design of the study looks like many studies do in sort of this part. There was a dose escalation and then a dose expansion of the selected dose, one-arm study. What we've seen is that sort of two things to highlight. One, what you measure is sort of how is the tumor shrinking or growing.
What we see across the patient population is that more than 75% of patients have a tumor that is actually shrinking. This is a very difficult population to treat. Notably, on the left is that there are no primary refractory patients, no patients who have tumors that grow fast already at the first scan. It is an encouraging picture in terms of are patients' tumors shrinking or not. The other part is what you want to, I mean, maybe the key element is evaluating how long it takes until patients progress and you need to move on to the next treatment. What we've seen, the median time here in the study was 10.9 months, which if you do not know what to compare with, does not tell you a hell of a lot. 10.9 months is a very good number.
Just to sort of make a comparison, recently a prospective study, and this was in Korea, and I'm showing it because we had a lot of our patients in Korea, and it's the same group that we worked with as well. They showed in a prospective study looking at then LENVIMA alone, remember, we do Fostrox on top of LENVIMA. What we want to do is we want to be better than this. What we've seen from this study, if you take the number 10.9, that number that you compare with here is 5.4 months. If I put them next to each other, oh, there we go, next to each other, then the time to progression 10.9 in the combination, 5.4 with LENVIMA alone. The response rate is double.
If we look at sort of the median overall survival, how long patients sort of live, there's also an extension in the combination versus the LENVIMA monotherapy. The one-arm data is quite encouraging in terms of sort of showing a benefit. You won't know the true benefit until you do a comparative study. That's the next step. The rights issue that we are doing, and that's starting on Monday, the purpose is to run this, which is a randomized comparator study, 40 patients in each arm, where we then compare the combination of Fostrox plus LENVIMA versus LENVIMA alone. We will continue to work with the Korean group, one, because they're really good at running studies. Two, liver cancer is actually more common in the East than it is in the West. It's a good place to start.
The third part, and quite important, is that they are able to run the study with speed. We have a window to possibly get to the market first. We want to make sure that we take that window. By running this study, we're able to sort of initiate patients in the beginning of 2026, and we should see data by mid-2027, which will then enable us to sort of move forward and design sort of the registration program on the back of that. While we're moving fast, we also want to make sure that we extend sort of patent protection. One of the things that we are doing, sort of extending patent protection, is the combination patent of Fostrox and LENVIMA that has been approved previously in Europe. Now we have it approved in Japan, and we're anticipating approval across other major territories.
Usually a combination patent is not perhaps the most important element, but in this particular case, where liver cancer is the only tumor which we are developing Fostrox for, and we are doing it in one combination, this particular patent will be quite important and will be difficult to get around from a competitor perspective. This extends things quite nicely. To sum things up in terms of what we are doing and where we are, on the upper left, we have found a way to target tumor cells in the liver locally and minimize systemic side effects outside of the liver and also minimize negative impact on healthy liver cells. The data that we have generated in the first study, the one-arm study, is quite encouraging.
What we're doing now is sort of confirming that in a larger randomized comparative study to show the benefit before we move to a registrational program. If things go as we want it to go, if we're able to get there first, that market is worth north of $2.5 billion annually. With that, thank you.
Got a question here asking you to elaborate a little bit on the competitive landscape and how you view it.
I mean, one of the reasons I emphasize it, sort of the opportunity to get there first, is that sort of there's quite a lot of competition in first line. There are numerous immunotherapy combinations all trying to win in first line. When you come out of an immunotherapy treatment, you need to move to something else to overcome the resistance. You need to move to a different mechanism of action. The interesting part is that everyone is targeting first line. Everyone wants to win in first line. There is very little development going on in second line. We do see a few studies evaluating immunotherapy after immunotherapy, which we know from other tumor types, it just doesn't work.
With regards to coming with a different mode of action and a different combination attacking the tumor from a different angle, so that we are at the forefront.
Also a question asking you to sort of summarize the strategic focus for 2026, like you do the rights issue and then.
I mean, the rights issue and the whole purpose of the rights issue is primarily to run the study. We are sort of working away with the Korean group sort of quite rapidly to initiate patients in the early days of 2026. We are estimating a 12-month enrollment. We know from the Korean sort of group before that they are usually able to recruit faster than that, but sort of we've said 12 months. To sort of start seeing data since the primary endpoint is overall response rate, which we can read out quite quickly, we do anticipate sort of for the first data in sort of mid-2027. We continue to work with our other assets sort of as the one with remetinostat to find other ways forward.
Clearly the focus is to get the study up and running to be able to move it into registrational phase as the next step.
Because that was actually the final question here was about remetinostat study and how sort of branching into dermatology-oncology partnerships might potentially change your strategic focus for next year or not at all.
No, no, no.
Just that to one side.
For us, I mean, we made a conscious decision. This is what we do. We drive Fostrox in liver cancer. The other assets we find homes for. That is why, sort of, because we can see the benefit of remetinostat study, particularly in orphan disease basal cell carcinoma. But it is for someone else to drive it, someone else to do it, because we think that is the most effective way to get it done.
Thank you so much, Jens.
Thank you.