Good evening, everyone. Welcome to our ASCO Investor Relations event and key opinion leader panel. I'm Sarah Pellegrino, Head of Investor Relations at Iovance, and just want to remind everyone before we start that the presentation will be including forward-looking statements which are outlined on this slide. We have a fun agenda for everybody today. We're going to have our Chief Commercial Officer, Dan Kirby, provide an introduction that will include an overview of the five-year data analysis that we're presenting at the ASCO conference this week. And then we will have our KOL panel discussion with our panelists. So there will be a Q&A session afterwards, where everybody will have an opportunity to ask questions of the panelists, as well as our executive leadership team that are all here in the front today. So with all that introduction, I would like to welcome Dan Kirby, Chief Commercial Officer.
Thank you, Sarah, and thank you everyone for coming out tonight. So at Iovance, we have two products, Proleukin and Amtagvi. And with Amtagvi and Amtagvi's launch last year, we've treated 300 patients since launch. We treated over 1,000 patients, commercial and clinical. We have over 80 treatment centers up in the United States, and the most important number here is 70,000+ patients that are suffering from metastatic melanoma that we can help. Payer coverage since launch has been extremely strong. We have 3 pending approvals, ex-US, in the U.K., EU, and Canada. We currently have 11 clinical trials, 3 Fast Track designations, 1 Breakthrough Designation, and 1 RMAT designation. As Sarah mentioned, our 5-year data will be presented on Monday. Here's a high level.
About 20% of the patients from the entire study are alive at 5 years, and that is remarkable, considering this is a one-time cell therapy treatment. It is the only one-time cell therapy treatment in the metastatic melanoma space. Our overall response rate of 31.4%, and our median duration of response has been met at 36.5 months. Again, all from a one-time treatment. A third of the responders had ongoing responses at 5 years. This leads to a meaningful overall survival benefit. Deepening responses observed were observed over time, and no new or late-onset adverse events. And again, one-time treatment, no long-term adverse events. That is extremely unique in the oncology space. As we think about how immuno-oncology and cell therapy have advanced, in the 1980s, you had stem cell transplant.
For the first time, taking an immune system of a healthy patient, a healthy donor, and replacing that—putting it into a diseased patient and changing the course of therapy. This was limited, though, long term, to liquid tumors. Cytokine therapy was introduced, monoclonal antibodies, therapeutic cancer vaccines into checkpoint inhibitors, and finally into the first commercial cell therapies with the CAR-Ts. Again, they were in the liquid space. In 2024, that narrative changed with the approval of Amtagvi, the first solid tumor cell therapy with a one-time administration. So with this, I'm going to start the panel introductions. I will mention, one of the pioneers of TIL is up here, Dr. Peter Prieto, with Iovance, was actually in Dr. Rosenberg's lab at the National Cancer Institute and has over 20 years of TIL experience. The rest of the panelists are Dan Olson, Dr.
Dan Olson from University of Chicago, Dr. Geoffrey Gibney from Georgetown University, and Dr. Bruce Brockstein from Endeavor Health in North Shore. So now I'll hand it back to Sarah and Peter to start the Q&A, start the panel. Thank you.
Great. Thank you so much. So for all of the panelists, after seeing the five-year data that we're presenting here at ASCO, what are your initial thoughts on these results? Dr. Olson, do you want to go?
Sorry. Yeah. So, I mean, it's wonderful to see long-term responses in patients. I think that's what we have been fortunate to experience with patients in the frontline setting who respond to immunotherapy that, you know, we can have durable responses. I think we know from experience, and especially in the last 10 years, we've seen those advances, and we know roughly half of patients are not going to get a long-term response from checkpoint inhibitor therapy, and we've had limited options for those folks. And so, yeah, it's phenomenal that we can get some of those patients back to those long-term responses and controlled. So, we know the field has been really limited in what we can offer patients and what's out there, so, the ability to have that has been, you know, fantastic.
So we've been really happy to at least have that option and then, you know, ultimately now experience it with some of our patients.
Yeah. So just to complement what Dan has said, I think 20% five-year survival in this population is pretty impressive. And we don't really have other studies that have shown it to date. So, you know, I think once we can digest the data as it's presented, I think this is very exciting, and knowing that a third of patients seem to have a durable response, you know, this is all new for us at this stage of their disease course. There aren't other studies showing this type of benefit in patients, so I personally am very excited.
Right, and I would agree, I guess, a couple of points. Number one, that's. It's 20%, which is, you know, not 50% or 80%, but starting out from the first time point, about half of our patients are cured with checkpoint inhibitors, so then you've got 20% of the remaining 50. So we could say that from the beginning, we could have long-term benefit or cure in close to 60% of patients who are eligible for Amtagvi.
... so that, that's really inspiring. Number two is just, you know, as someone who's been treating melanoma patients for almost 30 years, and initially we had very little, and then, you know, there was the hope of checkpoint inhibitors, which came to fruition, and then, there's always kind of that hope, you know, that question of what's out there and what's next, and this is kind of what's next. So it's great to see, and it's great to be able to kind of witness the fruition of all these things.
Durability, I think.
Yeah.
You know, for immunotherapies, it doesn't matter if it's TIL therapy or, or another class, we want to see durable off-treatment response. That's our, that's our goal. So the fact that it looks like we are seeing that in the, at least the abstract that's been presented to us, that, that's exciting to see. That, that's our goal.
Great. And for Doctors Gibney and Dr. Olson, for your advanced melanoma patients, what are the benefits of early treatment with Amtagvi?
Yeah. You know, as a patient goes along through their treatment, you know, melanoma gets harder, it progresses, and we know the patients, as they advance, it can be harder to get them to any therapy. And that's one of our lessons from this, is that, you know, we have a certain timeline for manufacturing, we have a certain timeline for fitness or how patients are going to do overall, and it's really important to try and start the process early, get patients educated about this, but then also think about introducing Amtagvi when, you know, we have the chance to do so. So we know it's a limited window. We know there become complicating factors in terms of prior treatments, how they might impact subsequent response.
So, you know, I would say my experience having gone through this, having treated, you know, a number of patients, we think we're up to 25 patients at this point, that, you know, those patients who we do meet sooner, who we get in the process, it goes much easier, but we're also seeing that it tends to work better. So I think it is really important to get those patients identified earlier, get them to treatment earlier, and certainly talk to them about it early in the process, especially if we're starting to see that we're not getting a good response to our first-line treatments.
I, I would agree with that. I think the identification of patients early in the process, even before they would be eligible for the treatment, to start the discussion and planning, I, I think is very important. Because the timeline is, is key here, that you have to be able to strategize with the patient when it is appropriate to do the, the tumor harvest and move on. Sometimes patients technically meet criteria, but their disease pace isn't quite the right tempo. Other times, it lines up perfect. So trying to figure out the right patient that you can move forward with, I... with the TIL therapy, I think is-
Mm-hmm
... become sort of the nuance, the science of figuring out the right patient for the treatment, which as long as you start earlier, you can capture quite a larger range of patients.
Great. Thank you. And Dr. Brockstein, what has been your experience with referring patients and some of the benefits of having earlier referrals?
Right. So, you know, the complexity from, you know, patient identification to eligibility to actually getting infusion of the product, and you want to kind of decrease that complexity and that timeline, so you have to be thinking ahead. For me, it's establishing a relationship, which is with Dr. Olson. We've, you know, been colleagues for a long time, so that was helpful. And I think for people who may not have that collegiality, making sure they kinda know who that person is. But for us, trying to streamline the issues related to timing of treatment, insurance approval, selecting a tumor to become the product, and making sure that there's the appropriate surgeon who's kinda seen or met that patient, or at least thought about that patient.
So I think once all those things are in place, then when the patient is ready for treatment, 'cause I try to refer my patients prior to their even their eligibility for treatment, but when you kinda can see it on the horizon, then in a sense, you can kind of make that call, hit the button, and everything starts flowing very quickly. And that's been our experience, I think.
Great. Dr. Olson, how does T-VEC intratumoral therapy fit within the landscape now that Amtagvi is approved?
So T-VEC, we think of, you know, initially was studied, this is an oncolytic virus, so it's a therapy you inject into melanoma. But, you know, predominantly was studied in earlier phases of disease. You know, it was being developed around the time the checkpoints were coming into play. So, a lot of its benefits were best described in earlier lines of treatment, are less relevant right now when we think about, you know, our PD-1 refractory, so patients who have progressed on first-line treatments. So, you know, for T-VEC, we really use it, you know, really in select situations. So, we know from some of the previous trial data, it looks like it doesn't generate responses in faraway tumors.
So if you have, you know, patients with disease that's kind of come up their leg, we call it in-transit disease, sometimes it's useful in those circumstances when, you know, that's your only option in the moment, that we would sometimes use it in those situations. And every now and then we see a response, but it's not as good as what we would see if they had not been exposed to prior checkpoint therapy. So, it's useful in some circumstances. I think it's a different patient population than what we would consider for TIL therapy. You know, those are patients really with more limited sites of disease, not so much someone who, you know, is progressing or has larger volumes of tumor, things that we would make TIL therapy from.
I think overall, more limited role for T-VEC in a different patient population.
Dr. Gibney, what's your perspective?
So, just like Dr. Olson, when the data came out, originally, it was when PD-1 drugs were just becoming really more available and used, and the data, it doesn't really... I would say it's not as relevant now that we have other drugs. So the systemic response with T-VEC has been fairly limited. So by the time patients get to the point you may be using T-VEC, they already have disease throughout their body. So, there's the exceptional patient that has maybe in-transit disease in an extremity, and you might try to inject a few sites and then continue to inject, but it hasn't really been-
... a primary treatment option that we've offered patients once they have widespread disease. It's really been an option when we don't have anything else to offer. In terms of, in relation to, like, a TIL therapy option, we don't look at them the same. So if the patient's appropriate for TIL therapy, you know, the T-VEC discussion doesn't really come into play.
Great, thank you. So given the success of your ATCs, the tremendous success over the last, over a year, we'd like to maybe pivot now to the expanding and perhaps earlier access of Amtagvi to your patients, and especially within their care plan. So Dr. Olson, can you, can you speak to the, to your ATC at the University of Chicago and how you've accelerated timelines for things such as financial clearance, tumor tissue procurement, scheduling? How is that continually improving throughout the last 15 months?
Yeah. So it's, there's a learning curve. When you begin TIL therapy in the process, it requires, you know, a real culture change in terms of your workflows, how are you seeing patients, how are you getting them to see surgeons. It used to be when patients had advanced melanoma, they were really only in the world of the medical oncologist. So, you know, now we have to go back to the surgeon and say, "Hey, we need you again. You know, we need your help with this patient." So, getting your surgical team to be on board is crucial, and we're very fortunate that we have, you know, dedicated melanoma surgeons who are very excited to be back in the picture and treating these patients and being able to help offer them, you know, something bigger than what we had before.
So I think that's the first, you know, key step, is having a, you know, a surgical collaborator. And then in terms of the other processes, you know, we had to do some patients and get experience with this 'cause it's very different from how we treat patients previously, where we, you know, prescribe a drug, get insurance approved, and then start the drug within a week or two.
So, you know, our process has been to, you know, use our cell therapy program, the same people who do transplants and CAR T cells and have a lot of experience with cell therapies, and then they also have financial specialists who are, you know, familiar with dealing with payers and have different relationships, and essentially set up a process that as soon as we start a patient, or we're even thinking about TIL therapy, you know, I'm writing an insurance letter at the end of my encounter, we're starting the process so that, you know, when the surgeon says, "I have a spot in the OR next week," we can hopefully get the, you know, the patient approved by then.
Sometimes the timelines are different based on surgical surgeon availability and OR times, but the goal is to try and get approval as soon as possible. So that's just now become part of our workflow to, you know, build that in so that we work on that right away. And there's, you know, different relationships with different payers. Like our Medicare patients, we know we can pretty much start right away. It's gonna be very straightforward. You know, some of the different payers that are very common in the Chicagoland area, we know exactly what our timelines are gonna be, and it's worked out.
One thing that's been interesting is that, you know, when you become a TIL center, you know, certainly in the early days, too, we were the only one doing it in Chicago, so we were getting people coming far and wide and places that are not part of our referral network. So we were having to reach out to different centers and different payers from out of state, and that required a lot of work, but that process had happened with the CAR T experience before. So fortunately, we had people who were, you know, able to do that. So, I didn't know that that was so important when we started this, but, you know, you do it, you figure it out, you realize it is really important, and then you get your cell therapy team, which has already been through it with the CAR T experience.
They certainly had a lot to contribute, and it made it a lot easier for us. And then on the, you know, the logistical side, too, is that, and thinking about referral patterns, you wanna have good relationships with your referring doctors so that they know to send the patient to you, hopefully before they absolutely need to start the process, because you wanna be able to control the timelines. You know, if you have a sense that a patient's gonna be progressing or you know they're gonna have a scan at a certain date, you wanna be ready for it.
So that's been part of the back and forth, is, as we get more referrals, I meet new doctors who had never sent me patients before, but because we're an approved treatment center that's now established and I get to know them, we do our first patient together, and so when the subsequent patients come, I'm hopefully meeting them earlier, and then when we're ready to go, it happens, you know, much faster.
Thank you. Dr. Brockstein, as a leader, really, of a large community oncology practice and really serving as a model for what good looks like from getting patients into Dr. Olson at the University of Chicago, have you given any thought to becoming an ATC yourself?
Yes, and it's my sincere hope that we could become an ATC soon. So just as background, for the audience, I'm at Evanston Hospital, which is part of a nine-hospital system now called Endeavor Health, a conglomerate of three or four smaller health systems now for the last year. So we have one medical group with 2,700 doctors, one medical record. So big referral base and big referral pattern. We're still a community hospital, but academically minded and have the academic component or an academic community hospital. So while I've had actually a great experience referring my patients to Dr. Olson at the University of Chicago, it's my goal to be an ATC for, you know, my patients, my hospital's patients, but also for our hospital system.
And so we've got the, you know, we've got the infrastructure. We do CAR-T therapy already, so we have that component with the cell therapy coordinators, the financial clearance. And for us, you know, it's really kind of just plugging in two things. One is the surgery piece of it, which, you know, I've already talked to some of my surgeons to kind of alert them to that, and I think that component will be relatively straightforward. And then kind of reinvigorating the IL-2 part. We were an IL-2 center before checkpoint inhibitors, so that part you kind of have to have in place, so that's just gonna be plugging that back in. So, it's my hope that we can do that soon.
We've got a good patient population and then kind of the referral base internally and hopefully externally.
Great.
...Dr. Olson, you have a really successful early large volume ATC. Can you speak to any Iovance initiatives or, or team encounters that helped you kind of master the learning curve there?
Yeah. So as we mentioned, the learning curve was steep, but there was a lot that we had to pick up as we started, and there were things that, you know, when you begin, you don't know what you don't know. And so I think as we did our first patients, we realized the scheduling piece to have the courier there at the right time, to have this, you know, set expectations with the surgeons to where, you know, they're not thinking necessarily about the timelines of progressive melanoma. This is not part of their day-to-day practice, and so establishing the urgency, I think that was really important initially.
And then, yeah, I think once we built that into place, you know, making sure that everyone understood what was, you know, necessary to get one patient through treatment, that was really important. And I think, you know, in terms of being a high-volume center, it's been, you know, working with a really functional cell therapy group. And so I'm fortunate that, you know, I take care of seeing the patient, saying, "Who's the patient that's going to move forward with TIL?" Work very closely with the surgeons, and then when we get them through their surgery, you know, we check in on them, we talk about any, you know, bridging therapy or what needs to happen in the meantime.
But when it comes time to treat them, I hand them over to my cell therapy colleagues, and these are, you know, team members who treat, you know, all kinds of blood cancers. They do our studies for cell therapies. They're all very familiar with IL-2, but they kind of take over. And so that's, you know, great in terms of workflow, because once, you know, patients are on their service, I have full trust that they're going to handle them. I'm still involved if they call, if there's questions, but really, they, they do the bulk of the actual treatment, and that, you know, allows me to work on the, the other patients who are coming through and, you know, making sure we're setting up more patients for it. So I think that division of labor has been really helpful.
And then, you know, a big piece of this, and I think the part that I think about the most in terms of, you know, creating a center and creating, being able to offer this to more patients, is the communication with the referral doctors. So as I mentioned, you know, this was a you build it, they will come. So I didn't know where all these patients were initially. And as, you know, some patients come in, I get a relationship with a doctor who maybe is in the community, maybe is downstate, and, you know, they don't know so much about TIL, but then we share a couple of patients, you know, especially when things go well, you know, they start referring more patients. We start talking on the phone more often.
You know, we kind of establish this relationship, and that allows more patients to come in. So I think the ability to create those relationships, and we've had some help with the Iovance team, especially in reaching out to some of them and talking to them about the process, that's been really helpful. And then the surgical procurement piece is also, you know, every bit as important to educating the new surgeons as they come on. So we have a primary melanoma surgeon, but she does mostly surgeries that are, you know, skin, soft tissue, lymph nodes, but then we have tumors that are in unusual places. So it's going to be, you know, thoracic surgeries. We're going to have head and neck tumors. We had a...
We needed a neurosurgeon for one tumor to get something close to the spine, and, you know, they've never heard about TIL. They don't think about melanoma. So when they have surgical questions, they talk to our surgeon, but they talk to Iovance, and I think that's been one of the more important pieces, is the just availability to be able to pick up the phone and call anyone. So when we have an issue with, you know, courier scheduling, questions about surgical procurement, timelines, the availability to, you know, talk to our teams at Iovance and say, "Here's the, the new person. Can you talk to them about this?" If we have a question, we can talk to them, and that's very different for TIL therapy than any other therapy we do in melanoma.
I don't know people at the companies, really, for most of the other therapies. You know, I don't troubleshoot anything with them, but this is hands-on and, you know, the team's been hands-on, and that's certainly made it successful. I don't think we could do it if it wasn't that easy, where I can just, you know, have someone's cell phone number and call them and say, "Hey, help us get through this.
Great. So I think that's a good segue to our next topic around the patient experiences and future growth. How are Chicago and Georgetown working to build more awareness that can drive more referrals into your centers?
Sure, happy to start. So we have a large network within our MedStar system, so that's where we've had a lot of the patients coming in, as well as from other larger hospital systems in the area, from Maryland, Virginia. What we've been trying to reach more is the community doctors, most recently. So the more academic-focused melanoma providers in our community have known about it, been very aware, and actually sending a lot of patients to us without any effort. So we've been very fortunate with that. The key is reaching out to the community doctors, where this is maybe not on their radar or they're not aware of the timing, as we've been talking about getting the patient in earlier.
Our institution has a large outreach program and promotional programs where we're providing educational materials and trying to put the connections in place with the community doctors, and it's been a work in progress with different ways we're reaching them, direct email communications, using different mailers and so forth. But we're now building those connections for the referrals, so we're creating a network as you were describing earlier, where the patients hopefully will be seen for a consultation earlier in their disease course, may never really need my services, but if they do not respond well to their immune checkpoint inhibitor or whatever therapy they're about to get, that they're already plugged into our system, and we can move forward with the screening process pretty efficiently.
So this is, I guess, a work in progress, but we have systems in place. We also have a nurse outreach manager who literally goes to practices and provides some information on what we offer at Georgetown, and this is one of the key pieces for Georgetown.
Excellent. And, as Dan's been talking a lot about, Iovance has a lot of initiatives, out in the community to help drive more referrals to our, current centers and new centers. So, Dr. Olson, will you want to add anything?
... Yeah, I think that's been really interesting, is how this has allowed us to, you know, see more patients, and that's been. It's been helpful to be able to talk with folks at Iovance who are willing to go to some of these different centers. And, you know, many community oncologists are going to have a handful of patients with melanoma, and a subset of them are, would be, you know, eligible for TIL or need it. And so it's really hard to, you know, broadly educate a huge population of people across multiple states. Like, we see people from, you know, many of the surrounding states, so that's, it's a huge network of people. So you'd spread yourself thin trying to tell everyone about TIL.
But the key piece we've kind of realized is that there are groups out there where it's a big enough practice, where among community oncologists, there's someone who's going to have a melanoma focus, someone who's going to be, you know, thinking more about what's coming up, what's... You know, what do I do for my patients after our standard therapies don't work? And so it's really been finding those people. It's sort of the middle person who's the person in a practice who a larger group would say, "That's the melanoma doctor." Even though they might still treat multiple cancer types, they're going to have, you know, a greater awareness of what are the new therapies, what's coming up, and so finding those people and then connecting with them, that's hugely important.
When I look at where our referrals come from, it's really a select group of people in those types of practices who it's the melanoma doctor from, you know, XYZ geographic distribution, and being able to connect with them. We've recently been able to coordinate with some of the team members from Iovance and some of our sort of physician liaison folks who try and get more referrals to come in to actually be in those practices. And so I'll join, you know, their tumor boards or their conference just to talk about the process, you know, get them to know me. The biggest part, though, is really just like: how does that person know that they can call me and talk to about it? Because as things come up, you don't want this to go through multiple layers.
You just want it to be direct, and they can call me, text me, figure things out on the fly. So that's, that's been the most important piece, to build a program, is to identify those people who would be interested and then make the personal connection, and all the details and other things that go with it can flow from there, but that connection has to happen.
Good. Dr. Olson, having treated several patients who now have some longer-term follow-up, what have been your observations on durability with patients in the real world?
Yeah. So we, you know, we're now roughly at a year where I was able to look back, and it's been a busy year. We treated 25 patients at this point, and we've had... You know, we've seen really good activity. We've had a 40% response rate, looking back at those patients treated in the last year. And, you know, some of them are recently treated, so we're waiting to see the durability, but we've had some that have been really impressive, and we have had, you know, a few patients who've gone to a complete response, and they've stayed there. So that's been amazing. So I think, from what we're seeing, it's active. You know, the patients that we were treating initially, especially when TIL was approved initially, we had people who were waiting for therapy, people who were progressing.
It was really hard, and we were wondering, you know: Is this going to be possible? Are they going to be able to hang on? And so, we definitely treated sicker patients than what would be... You know, we'd consider clinical trial patients. They had other things going on. And so we've seen that the response has been, you know, it's been excellent. It's been every bit as good in the trial, and so the fact that the activity is staying there, even though the patient selection, just based on the nature of where we are and where patients come from, is maybe not always ideal, has been encouraging, and so we've had, you know, some really good experiences.
Dr. Brockstein and I have shared some of these patients, and even, you know, some of the earlier patients we treated have done great and have stayed that way. So it's been really encouraging.
That's great. Before we open up to Q&A, we would love it if each of you could comment on a patient success story, from your experience.
I'd be happy to go first.
Great.
Might be stealing one from Dan, but— So a young woman, early fifties by the time she was treated with TIL therapy last year, who'd been my patient for about 15 years. She had a extremity melanoma, and over 15 years, she kind of relapsed about every year to a year and a half, mostly localized to her leg initially. So she had surgery, surgery, had multiple tumors, had a limb perfusion, had radiation to an area of multiple tumors, had T-VEC. And that was kind of all able to kind of bridge her along a little bit. We had the conversation over and over about, like, you know, there may be still something better coming. I think she may have had a clinical trial or two. Your disease has grown slowly.
Hopefully, something will come along, and then cell therapy may be coming. And I think she had already been referred to Dr. Olson, and was kind of teed up to go when she developed her first tumor outside of her leg, which was a pancreatic metastasis, and she was acutely hospitalized in very bad shape, couldn't eat, had pancreatitis. I think she had obstruction of her biliary tract. So that's where the communication came in. We basically had to try to stabilize her, which I didn't think we would, and then as soon as she was stabilized, she really needed to get right to Dan because there wasn't going to be a window beyond a very short period of time. Her cancer was then growing very quickly.
So we got her out of the hospital, and I can't remember how many days, but very quickly got her back to Dan. And she had a complete response. It's been over a year. She's back to her normal lifestyle. She felt great about two or three weeks after. And you know, that, for me, has been, as an oncologist, that's about as gratifying a story as you can have, and in particular, with someone who you've built a relationship with over 15 years. So I'm very thankful for the drug and all the work that kind of went into it and the availability of nearby quick treatment. So...
Yeah. So, you know, I think the most memorable one for me is probably the first commercial patient we treated. Just as Dr. Olson was alluding to, the logistics, sometimes you don't recognize what you don't know until you go through it. And going through that with the first patient for us, we had already been doing this on trials, but commercial treatment, the logistics, some of just the systems that get put in place, the timelines, everything is a little bit of a learning experience, and now we feel very confident with it. But at the beginning, you know, we were trying to figure out some of the things, and, you know, the patient-
... was very aware, this was a new treatment, and that we were doing the journey together, in essence. Not that we couldn't offer successfully the treatment, but figuring out the logistics with, like, the insurance and scheduling the tumor harvest. The patient, at the very beginning, there was a little bit of timeline getting them set up for treatment, and we had to use bridging therapy with chemotherapy. While a lot of times we're not very excited about chemotherapy, it actually gave us the window that we could then offer it to the patient, and everything lined up quite well.
Surgery went well, and moving forward with the treatment, I personally take care of the patients in the hospital, so I'm very close with them, and it's a lot of trust that the patients put on you and you with them-
Mm
- and the communication, and you really bond with them and, helping them go through the experience, and, you know, it's a lot to go through. We talk about a sort of a roller coaster, and, you know, they have to have faith in the team. And, things went as smoothly as we could expect. Patient was extremely grateful and, and doing really well so far. So it's been exciting, and that was our first patient, and we've seen a success with other patients as well.
Yes, I shared the patient that Dr. Brockstein mentioned, so that was, you know, was wonderful to see. We've had some other, you know, really excellent success stories. I think thinking about which one to highlight, there was one patient who was 84 when we decided to do this, and I remember he came in and, you know, he's like: "I'm interested." And I looked at the trial, I looked at other TIL trials, and I looked at the upper range on table 1 of the trial and said: "How old-- What's the oldest patient that's been treated in these studies?" And he was, you know, about 10 years older than those patients, so... But he was adamant, and we-- I had some other doctors talk to him who did sort of functional assessments, and the guy was really fit.
And so, you know, we talked to him about it and said: "Here's, you know, you're at this level. This is very different than what we've done before, but we're going to try." He responded, and he did really well. He got all 6 doses of IL-2. You know, it really led us to believe that we know we can treat some patients who are, you know... The age is not the issue, it's more the functional status, how they're doing. So I think it made us feel much more reassured that, you know, if we select patients based on physically how well they're doing, that we can treat some older patients, and then to see it work so well for him.
He really cruised through it and was back to being on his bicycle and doing his things within three weeks. So that was an amazing experience.
That's great. Thank you all so much, and we really appreciate you being here on the panel. So now we have our Interim President and CEO, Dr. Fred Vogt, will help lead the executive leadership team in answering the Q&A portion of our event, and our panelists are also up here and will be available for questions.
Hey, great. Salim Syed with Mizuho.
Thanks for all the color today, and congrats on the five-year data. I guess a little bit of a longer-term question here, maybe for the doctors on the panel. I don't know who's most appropriate to answer this. So you have-- we have five-year survival data now with Amtagvi, but we're also getting additional data from... We got some data from Immatics today, right? And, you know, they were pushing uveal. I think the OS data was similar to what Amtagvi had in the cutaneous.
But, you know, in the interim readout that we're going to be getting, I think probably in the first half of 2026 for their phase III, is there anything that you guys are particularly looking at that can sort of, you know, make your thinking a little bit more granular, where you might treat with Amtagvi versus their product, the Immatics product, and just other things you're looking at as we get further data in those readouts? Thank you.
Go ahead.
So, I have not been personally involved in this study, but the understanding that I have is it's... I believe it's HLA restricted.
Mm-hmm.
So that's HLA-A2 positive patients. Only half the Caucasian population is HLA-A2 negative, and if you're not Caucasian, the probability is even lower than 50/50. So right off the bat, there's that distinction between what would be potentially a decision where you'd have to pick one or the other if they were equivalent. I think the data, you know, ultimately speaks for itself, though. If one product's better than the other, you know, we, as clinicians, would want to offer the best product, and I don't think we know yet. I mean, the data is still early for Immatics, even though it looks exciting, but it's really hard to know how they would stack up head-to-head. And, you know, obviously, there's big differences. One, Immatics is going after one antigen specifically, whereas TIL is bulk going after multiple antigens. There's pros and cons to that.
You know, I think it's really hard to know which one, if they were put head-to-head, would actually play out stronger at this point.
So I think there is Amtagvi in the comparator arm. I don't know if there's anything that's included.
Yeah. So I think in the randomized phase III study, it looks like it'll be investigator's choice, and so some portion of those patients would be patients who get TIL therapy. So you'd have some signal. It's not. I don't think it will be a direct comparison because it'll be investigator's choice, and not everyone's going to have TIL, so we'll have to see what that comparison looks like. At the end of the day, you know, the data is going to speak for itself, and, you know, we'll look at some of the sort of key landmarks that you see with that. I think the response rate, you know, we think about that a lot, as being important, and then the duration of response will be key. So, we don't know right now.
I think that, you know, we've looked at some of the TCR T-cell trials, and even the phase I studies, you'll see duration of response is sometimes around 12 months, or sometimes they're reaching it, you know, not years later. They're- you're seeing it just at 1 or 2 years into the study. So I think that gets to the point that we have this mechanistic idea about, you know, personalized immunotherapy with TIL, where you're technically targeting, you know, multiple personal antigens, and you don't have to restrict to HLA. You, you think mechanistically that might work better, whereas when you have a single antigen and targeting, you know, one loss in an antigen or, you know, presentation of those antigens can, you know, undermine the whole response.
And so I think if you were to say, based on mechanistic thinking, there's some advantages to TIL, but at the end of the day, we have to see what those landmarks are when it comes out, because ultimately, that, that tells us.
Okay, and just to follow up, the importance of actually having absolute 5-year landmark OS data, does that have any impact on your thinking as we kind of get the less mature data out of the way?
So, big picture for melanoma, we reference those types of data points for our decisions, even with immune checkpoint inhibitors. So it is important for us to see those long-term survival outcomes. So 5-year data, I think it's exciting to see, and it helps support the use of the drug. We don't have that for other agents at this time point for a patient's journey, so I think that's pretty unique. So I would say it's helpful. I'm not sure, you know, it helps differentiate anything, because right now, I don't think there's a true comparator or alternative at the moment that you could stack it up against. Even the Immatics data that they've presented, I think, is still not quite that mature, and other data sets are not that mature in melanoma.
Yeah. Great.
Thank you. Pete Lawson from Barclays. So I guess for both company and also the clinicians on the panel, just the biggest operational bottlenecks you're kind of seeing, whether, you know, with the biopsy stage or the infusion stage, over the last, you know, three to six months, how you've seen that change? And then the other question is just around, if RP1 gets approved or oncolytic virus, how you'd kind of think about triaging patients between TIL versus oncolytic? Thank you.
You want to start? Sure. Yeah, so I can make a comment. I think, you know, in terms of bottlenecks in manufacturing, that's something that's unique to TILs, that we're procuring tumor, it's not from peripheral blood. And that was part of the big learning curve that we went through, was, you know, we'd had some experience with TIL studies before and, you know, what were the guidelines around how much tumor to take? And some of the selections were based on the trial experience, and so when we started, you know, we did have some trouble with manufacturing, but as we've gone through it, we've had, you know, active feedback, talking with, you know, essentially surgeon to surgeon.
You know, our surgeons can call and talk about that and talk about, you know, where to get tumor from, but essentially how much has been a big play. And so we've had, you know, a very good experience with manufacturing, especially in the last six months, where, you know, nearly all of our patients are being able to move forward. So that's been helpful. I think to the second question around with RP1 and, like, how that fits in, you know, to some extent, there's going to be separate patients that we look at. I think, you know, there are certainly people who will come in who are PD-1 refractory, who you're worried about giving any therapy to, and those are probably not the patients that we would have selected for TIL.
You know, people who, you know, you're really worried about that, and can you take the time to manufacture? Some of those patients, you might be able to offer RP1 to, that you couldn't previously, but that's, you know, might be a separate group. And then certainly the patients who, we would have thought about, like the T-VEC patients, the in-transit disease, disease that's not amenable to take for TIL manufacturing, that's certainly a group that I think, you know, new oncolytic virus would or RP1 would be able to treat those patients. When we get to the question of, like, if you have, you know, the choice between the two and, you know, you think it's reasonable to offer both, I think there's going to be varying opinions on that.
You know, my approach to that is thinking about it sort of pragmatically is, you know, with each therapy, you have a certain probability of response, and so, you know, if we have 40%, let's say, based on experience with TIL, and then we have 30% with RP1, you want to think about how am I going to give my patients two shots on goal? Because the probabilities are what they are, and so you're going to have to be thinking about subsequent therapies for a lot of your patients.
If your patient's coming to you, and they're, you know, in a fit state, and I have the ability to offer them TIL, if they're coming in, I think they're reasonable for TIL, we have a lot of experience with that, and we have the chance to offer it to them at that point. I think it's reasonable to do that, and if they don't respond, you can be treating them with an off-the-shelf product pretty quickly. I think in my mind, that increases the likelihood of doing, you know, that sequence because you get more likely to have two shots on goal.
I think if you do the opposite, you're going to be treating patients for, you know, potentially months on treatment, you see how things go, but if you're refractory to a subsequent therapy, you know, the ability to then take a patient through procurement until, you know, might be challenging. So, you know, that's sort of a pragmatic way to think about it, but at the end of the day, you know, that's... we don't know. There's no direct comparison, and so I think some of those factors will come in and, you know, what's your familiarity with each therapy? What's your institutional ability to offer each therapy? And then what's your geographic where you practice? Those things are going to matter a lot.
Yeah. Yeah. I would agree with Dr. Olson, and, you know, one of the keys is, are they truly comparable?
We don't really know the data with RP1. Response rate is in a similar ballpark to what we've seen here, but we don't have longer-term follow-up. Patients remain on treatment, so we don't really know the long-term outcome for RP1-treated patients at the moment. So if you have someone that has the time for tumor harvest cell manufacturing, we have experience and good data for TIL therapy, and, you know, I think that's still my preference currently with what we have for data.
... that may evolve as we have more things come out, but currently, this, it's hard to really even compare the two in a patient that could equally choose either one.
And I guess I'd add a couple things. I mean, A, the more treatments, the better, right? I mean, we had, you know, checkpoint inhibitors, and then we have targeted therapy for half of our patients, and that's great. That extends the possibilities for them. They're not mutually exclusive by any means. And, you know, I think Geof had talked about a patient needing bridging therapy with chemotherapy.
Mm-hmm.
This is another opportunity for bridging therapy for those people who may need something. So, from that standpoint, it could be a bridge onto that, and I think Dan talked about the probability, kind of calculation.
Yeah.
I had kind of alluded to the fact that, yeah, you know, we have, you know, almost half the people who can get long-term response or cure to checkpoint inhibitors, and then we add on, you know, another 20% of the remaining 50%, and hopefully, we could use the RP1 drug to, you know, either after TIL therapy or before TIL therapy to take that total number to a better number.
Mm-hmm.
I think even though it's an off-the-shelf product, it's still going to be more complex than most patients, people are going to use in the community. In my center, you know, we did T-VEC, IL-2, but we're a little bit of an anomaly in that way. So I think these patients would still see their ways to a tertiary center that does that overlaps with centers that do cell therapy and TIL therapy, and so it'll get them to a point to be able to do that true assessment and, you know, hopefully to both if they need both. So I guess I just view it as potentially another opportunity, but not a substitute.
So maybe I can add a comment here as well, I think, and it's consistent with what you've said. I think right now we, if we're talking about RP1 and TILVANCE, we just don't have data that allow us to compare them. The data that have been generated are generated in very different populations of patients. The TIL, TILVANCE patients, the lifileucel patients are much more pretreated. All of them were treated in the metastatic setting, while the data that we know currently about RP1 is in a much less pretreated population, and just not comparable with the data that we have for lifileucel, and I think that adds to the complexity of making choices here.
Yeah. And I think just to dovetail on that, we historically have a lot of TIL data from other institutions before Iovance developed lifileucel. But, you know, for the oncolytic viruses, it's still at uncharted territory where we have T-VEC, which was a success that it got approved, but the uptake was mixed, and we currently don't use a lot of it. So RP1, if it's successful, that's great, but it's coming from a different background, I would say, than, like, TIL therapy currently, where we've, we have a lot of historical data. Andrew?
Andrew from Jefferies. Thanks for taking my question. So for the doctors, how many high-quality referrals do you get on average per month? And high quality meaning, you know, community docs referring pretty early to you guys. And how do you foresee that number to change by year-end, and when do you think you reach that steady state number? Thank you.
It's a good question. I mean, some of this is unknown. I think I've been asked that question before. We're... You know, where do we think this is going to shake out? And I don't know, like, as I mentioned, a lot of these patients came from places that I didn't work with previously, and so it's kind of an evolving landscape, and there's things that are out of our control that we don't appreciate. So which centers pick it up? You know, which referring doctors, you know, learn about TIL and decide to refer for that? I think we found that there's been a certain population, but we know there's other people out there. So I think there's some unknowns to that. And, you know, I think about my personal experience and how many patients am I going to treat.
Obviously, that affects my, like, day-to-day life and how busy I am. So you always wonder about that. But there's, you know, things in the landscape that change, like there's other centers in Chicago who are going to offer it, and so maybe that decreases some, but then I have relationships with certain people who tend to refer to us, and so it could be that we see, you know, sometimes less or, you know, it changes, but our trend in the year has been that we've seen more patients, and it's been based on those new relationships with outside referral, you know, places that didn't refer previously.
So, you know, that's been our trend, but again, there's things that are happening in the world that we don't have control over, especially if there's other centers that come on that could affect it. In terms of the quality, that's gotten better as, you know, I develop those relationships and people understand what's important about selecting the patients early for TIL and, you know, having just a key group of people who refer, that really helps. But it still happens that you'd get patients who you meet and say, "You know, this is maybe not the best option if it...
You know, we think your melanoma is progressing and your probability of responding is low," you know, that we have to have that conversation, talk about, you know, doing something different or seeing if we can buy our time with another therapy and make it so TIL has a higher chance of working. But, I think the trend has been we see more and that the ones who do come are, especially the ones we have relationships with, they're people who are truly likely to be candidates for it, so the majority, I would say.
Yeah, I would agree. I'm getting, I don't know, anywhere from 1-3 referrals a week usually. Not everyone needs it immediately, so it's more establishing the relationship. I have 1 or 2 patients I'm seeing this upcoming week. I have 3 that I just got an email for over the weekend. I think at the beginning, when the FDA approval came, there was an influx of wer in ATC that people that were aware of the data, they didn't really know-
... where it was appropriate, but they had a melanoma patient, they progressed on immune checkpoint therapy, they sent them to us, and, you know, we had to implement sort of a pre-check screen with our intake nurse to make sure it's appropriate, they're at the right time point, sound like they're fit enough to actually go through it. So we've implemented actually a screening list of questions that our intake nurse will go through, and it's helped streamline it, and I think it's also helped the centers that are referring to recognize what an appropriate patient is and what would not be an appropriate patient. So there has been that learning curve, but even with that learning curve, you'd think we'd see fewer patients, but I think we're seeing more referrals coming in that are more appropriate.
Thanks, Yanyan Zhu, Wells Fargo. Dr. Olson, I think you mentioned you have treated 25 patients with Amtagvi. It sounds like you had good experience having, you know, being able to pick the right patient and resect the right tumor and had great outcomes. I was wondering what proportion would that 25 patient represent of all the post-PD-1 patient flow through your center? Is there any movement towards less pretreated and less severe patients as you, you know, progress either till now or as you look into the future? And ultimately, what proportion you think would be put on Amtagvi?
Yeah, my sort of rule of thumb has been I think it's, you know, if you have 100 patients who start out, you know, with metastatic melanoma, we're going to get 50% of patients to good responses to where we don't have to consider a subsequent line of therapy. And then, you know, of those patients, which ones are going to be eligible for TIL? You know, there's some that just aren't going to have tumors in the right place, or, you know, they've, you know, the procurement question based on where the tumor is, how big it is, or they have, you know, they're just a patient whose melanoma is in a state where they're too sick or they have other medical complications, you know, that might preclude another 25% of those patients.
So we're looking for this subset of, you know, fit patients post-PD-1. So, you know, I think it's not all of our post-PD-1 patients. That's just... It's not possible to make, you know, to feasibly treat them or get, you know, manufacturing successfully for those patients. So I think, again, in thinking about the patients who are coming in, it's refined to more of those post-PD-1 patients that I'm seeing are coming directed for TIL from people who've thought about it, so that's a higher percentage.
But you still do get the ones that are, you know, just coming after they've seen everything under the sun, and it's time to do anything, and sometimes they just get sent, and I think that's a challenge because I think there's different incentives working in different centers, and sometimes you, you know, if you have checkpoint inhibitor therapy, if you have BRAF/MEK inhibitors for patients who have BRAF mutations, you know, you want it... Those are active therapies, and that, you know, you oftentimes want to treat patients to maximum benefit, and, you know, ideally, we want to see those patients earlier and talk to them about it and think about how we're going to finesse the time of procurement.
But you don't have control over all those referrals, and sometimes you just have to see patients with where they're at, and the question is, can you get them on? And so there's going to be a population that you can't. So it's hard to give you the exact numbers. As I was mentioning before, so much of this is changing, and so much of this is just totally new system and new pattern of referrals that it's very hard to predict it. So I can't give you the exact number, but you know, I think that relationship building and then identifying your referrers and letting them know about, you know, the expectations and what it looks like, helps you get, you know, a higher percentage of patients who are really going to go forward with it.
Great. Thanks for the color. If I may have a quick follow-up, it sounds like you have great experience picking the right patient, right tumor. How much is that art versus a science, and where do you think, you know, is that a more broad, broadly teachable technique in your, in your opinion? Thanks.
Yeah. So, you know, some of this has just been mechanistic and practical thinking to sort of say, you know, what, what do we know about a patient's prior therapy? You know, we know the patients who are refractory to targeted therapy, those 50% of patients who are BRAF mutated. It's really hard to get those patients to any therapy if they're truly refractory because the melanoma kind of changes behavior. It metastasizes to the brain, it goes to places where it's hard to get tumor, or they just get sick really quickly. And so I think education around that has been really important for patients who have been on that therapy and we're expecting them to progress. We watch them really closely, and so that's been, you know, really important.
I think some of the other factors about how do we optimize this, it's a question for the group, where there are black boxes in our knowledge about patient factors that impact success. You know, you can do everything right, and sometimes things don't work for a patient, and we want to know, you know, what's the optimal site to get tumor from, and we have some ideas, you know, about, you know, selecting a certain size. We do things like use PET scans to pick, you know, find tumors that are active, that are new, that are not necrotic and falling apart.
So those are all things you can sort of logically think through and say, "You know, it makes sense that that would have a higher volume of T cells in it to make the product." And so we, we do those things right now, and we try to emphasize that as much as possible. But one of our larger goals is to, you know, work with the other centers who treat a lot of patients with commercial TIL to start answering some of those questions because we're all in our separate institutions, and, you know, I can speak for my anecdote of 25 patients, but we want to get the more collective experience. And so, you know, the goal is to create a consortium and actually start answering some of those questions and pooling the data.
But I think some of the key questions that we all wonder about are, what's the impact of prior therapy, you know, a patient's outcome, and then, you know, how well we can get tumor for them or procure, you know, product for them. And we all have suspicions that, like, you know, some therapies might, you know, work, work against us. Patients who have to be on steroids for an indication, patients who are refractory to those targeted therapies, you know, we want to know those questions so that we can really think about that because it's hard to say that we should be stopping a certain treatment or, you know, modifying certain treatments when we don't really know those answers yet.
So those are questions that we can answer in the next year, so that, you know, when we're treating patients years down the road, we have a better idea. But those are, you know, really important questions for groups of people who do see a lot of this and do a lot of it to try and answer. So we're gonna try and figure that out.
Yeah.
David Vogt from UBS. For the KOLs, I'm just wondering, for the smaller ATCs that technically do not have infrastructure or have limited infrastructure for TIL therapy, what do you think are some of the key barriers for them to start treating first patient? And then what are some of the timeline gonna look like for them to start treating the patients? And, and then maybe specifically for Dr. Brockstein, just in terms of your, your, your ATC, say you want to become an ATC, what are some barriers for you to, to, you know, to start becoming an ATC there?
Thanks. I mean, I guess, as far as the second part, the barriers would be internal, external. External is communications with Iovance and, you know, kind of deciding on when is the timing for expansion of the ATC pool. So it's not a barrier, it's just an issue of timing, and, hopefully, that'll be relatively short. Internal barriers, I would say if we didn't already have a cell therapy program in place for hematological malignancies, that would be a big barrier. There's, there's a lot of things that you've got to navigate through, and, you know, in some ways it may be easier to navigate that through, you know, if you've-- well, it's definitely easier if you've already done the CAR T and cell therapies. Not sure which is gonna be easier to start if you're starting fresh.
So for us, it'll be, you know, educating our cell therapy coordinator on this drug and this indication. I don't think that'll be a big thing, getting the surgeons in place. And again, that's gonna be our melanoma surgeons for, you know, 50%-75%, and the other 25%-30% is gonna be those, you know, kinda, you know, one-off indications. And, you know, we're, we're located in one institution, in one hospital. Everybody's a subspecialized surgeon. It's gonna be both straightforward from that standpoint and interesting, I think, to the surgeons 'cause it's something new.
There's gonna be the financial piece, and again, we've got the platform in place already for cell therapy for CAR-T approval, so this is gonna be the same people who are gonna be doing the prior authorization. And then the IL-2 part, I think is a little shock to the system. You know, we haven't done IL-2 for a number of years, but we had that in place. This is, I think, a somewhat easier version of the IL-2. It's 6 doses versus 14. It's... People have already gone through lymphodepletion, so they don't, you know, my understanding is they don't really get as bad of the IL-2 toxicities as they did in years past or as... So, so I think it's, you know, gonna be kind of aligning all those people together.
What we did when we started CAR-T therapy about 18 months ago was really kind of getting everybody in the room, identifying the workflows, kind of looking at it as a project management thing and getting the pieces in place. So it's a hurdle, but it's, you know, we've done it before, and so it's just kinda taking that same template. If you're an ATC who, you know, again, who hasn't done any kind of cell therapy, that's gonna take a little bit more, I think, hand-holding and guidance from Iovance, which I'm sure that they do, either way, and it may take a little bit longer.
Yeah. I, I think that's a good point, that you can really model bringing TIL therapy to your center if you have CAR T. You need the team for the initial intake, the screening. If you don't have it, you have to set it up. Usually, you'll have your financial officer start looking at the finances to make sure it's compatible. If you haven't done that before, that might be new for the team. If you don't have a cell manufacturer or cell facility, you have to set that up because someone has to help send the tissue and has to receive it, keep it cryopreserved until it's ready to go, and help thaw it. So if you have been doing CAR T or other cell products, this is bread and butter. This is easy.
Institutions might have a P&T committee that it has to go through. You know, ours meets frequently, others may not. But I think if, if you're talking about starting from scratch, it's, it can be a little bit of time, but if you have the infrastructure, it's, it's really not that big of a deal. The, the infrastructure for the inpatient is a little bit nuanced. You know, institutions like ours, and I'm sure Dr. Olson's, there's already a preexisting bone marrow transplant service. There's already people around the clock. They're already dealing with sick patients, so you can build off that. You can either use them or i-, bring in more staff like we did. Otherwise, you have to train and, and have the oversight for it, so it's a little more complicated.
All those pieces have to be put in place, which might take a little more time for some centers, but it's all very doable.
I'll note, we're not an ATC, but we just put the drug through our pre-P&T committee on Tuesday, so went through that hurdle.
All right.
Yeah, one comment I'd make on that, too, is that when you think about centers who are gonna pick this up and go, you know, move forward, it's a, you know, it's a lot of work. It's logistically complicated, and so, you know, the incentives have to align for the person who's gonna take it on, too. And so it's hard to do as, like, a, you know, a couple patients. You wanna have it be something that's part of your identity, and so I think a lot of people who are excited about doing this, you know, really see cell therapy as the first cell therapy. We know there's other things coming up, and it's a different skill set.
It's, again, a different structure and workflow, and so I think some of the motivation to do this is that we think it's going to create a different, you know, subspecialty within oncology to do this, especially as someone who doesn't treat blood cancers and doesn't do CAR T-cell therapy. You know, we believe there's other things coming too, and so, you know, it's. There's an advantage to jumping on this and getting used to it and building that program, is that you can do that with other things. And I think it also, you know, helps to allow you to really focus on things you're hopefully really interested in. I think that was my experience, is that, you know, by taking this on, it created a kind of a new identity, and it built a new program that didn't exist before.
So, I think finding people who see this as an opportunity to, create something new within their institution, a new specialty, you know, a new field of expertise, I think that's, advantageous. And again, I think it has to happen because, you know, it's not something you can do intermittently here and there. You have to have a team that works around you, and so if you're one-off doing this every now and then, it actually gets harder to pick up the pieces when you wanna do it again six months later. You wanna be doing it regularly and have it be part of a bigger program.
Yeah. I think, Dan, that's a good point, that maybe at the beginning, not everyone was super motivated to start building cell therapy programs and taking it on. But now a lot of our colleagues, everyone is jumping on board building these programs, and it's not just for TIL therapy, but it's getting your protocol for CAR T or the T-cell engager that has cytokine release syndrome that use overlapping services. So for us, this created a whole new group within our institution, a new position. You know, Director of Solid Tumor Cell Therapy is one of my titles. So it's created a, like, a whole new branch within solid tumor oncology, which is very exciting, and I think as this evolves, it's not just for the highly skilled academic centers. Other centers will figure out how to do it.
Mm-hmm.
Thanks. Thanks, Jim. Reni Benjamin from Citizens JMP. I guess just a couple of questions. How many lines of therapies the typical patient that's being referred to, right, for Amtagvi, how many lines of therapy have they gone through? What would be the ideal number of lines of therapy that you want these patients to go through, right? 'Cause at the end of the day, you, you wanna maximize the number of patients that are getting Amtagvi, and we have a certain dropout rate that's occurring. So I'd love to, to get some sense from that. The other thing is, Dr. Olson, you mentioned you treated 25 patients. Is that to date or since launch? 'Cause that's... It varies between, you know, two a month versus five a month.
Related to that, what do you think is the maximum number of patients you think you can treat at your ATC a month?
Mm-hmm.
You know, given the facilities you have? And kind of related to that, to Dr. Brockstein, even though you don't have the ATC yet, how many are you referring, you know, per month out of all the patients that you see? Thanks.
Yes, we've treated 25 to date, and you know, we onboarded pretty relatively closely after approval, but didn't really start to get busy until about April, May last year. So yeah, we're typically seeing you know, initially it was one or two a month. Some months were busier than others. There was fluctuation. As I mentioned, the referrals have been coming more often now. So I think thinking about like an upper limit, as I mentioned, it's busy, and so you can't treating 10 patients a month for one person is hard. You'd have to really change your system to do that. But you know, we've had months where we've had four patients come through, and we're able to do that, and I think you know. So certainly, we can treat more patients.
The upper number, I don't know for sure, but I think there are some as you have more, as you treat more patients with IL-2, that puts certain demands on, like, the nursing infrastructure. Sometimes the ratios of, like, how many nurses to a patient is different when we're doing IL-2, just because you need to be more hands-on with the patient. So there's some considerations like that that come up, and if we have busier months when the other indications, like CAR T-cell therapy or transplants, are busier, we have to start thinking about how many patients we want to have on a service at a time.
And so we have to make some decisions about how many people are gonna come on and, you know, we have based on all the different indications we think about, we can adjust that, but it that hasn't honestly come up very often, so getting to four or five per month would be doable. But that's based on getting the patients in the door to come through and know about it. So, that's you know, I think we have the capacity to do that. If we ever got to a situation where, you know, solid tumor cell therapy is totally different, then we have to really think about a broad restructuring and, you know, who's gonna cover the inpatient services.
So if we're all rotating on for, you know, 2 weeks a year to cover some service, and if you create a whole new solid tumor cell therapy service, you need 52 weeks of coverage, and so, that's a big ask for a lot of people, especially when we're used to working so much time inpatient. So, you know, that would be dependent on other therapies coming up and changing, but there's room to go, at least for us. And yeah, so I think that's possible, but if it got bigger, we'd have to really restructure and think about it. But we've done that before with transplant. We've done hard things if the therapies work, so we'd make it happen.
But there's no real upper limit. I think the hardest thing that we've had, and it's true for CAR-T, is the fluctuation in volumes.
Mm-hmm.
So how do you hire your staff and keep a consistent program if you don't have the same number of patients going through? You know, there's adjustments that you have to take. So as long as the volumes are consistent, you can appropriately plan to treat, you know, 5 a month or 20 a month. I think a lot of our institutions would figure out if we're able to do. At least I know our institution is modeling, you know, trying to figure out what we need for this number of patients versus, you know, increasing incrementally. I don't think there's a-
... a true upper capacity, at least as, as far as I would see it. I don't know.
Yeah, I can speak to an individual capacity, but-
Yeah.
As an institution, it could certainly be different. You hire more people, and more people get comfortable doing it. Yeah.
Paul?
Uh-
Oh, go ahead.
Oh, I think the question was how many have I been referring and trying to get a sense maybe of what community ATC would do? But, so I think since launch, I've probably referred 7-10. I think 3 or 4 have been treated. There's a couple more that are kind of on the launching pad for sometime soon, and some who just weren't eligible or didn't make it to the point of treatment. My patient population probably represents a third within our health system, a third of the melanoma patients within our health system. So, you know, if they all ended up coming to my institution, you know, you could kinda triple that number. So that may end up being, you know, in the range of 1 a month.
I don't— You know, and again, that's assuming only internal referrals. You know, I wouldn't see with just this drug and others, if cell therapy was limited to melanoma and just this drug, it might be one a month. If there's expansion to other tumor types, which is what we, you know, would foresee at some point in the future, then we'd have the infrastructure for doing more than that, but I think in that range.
Just the number of lines of therapy?
Oh, yeah.
Yeah. So it's variable, so I think only about maybe 20% of the patients going through are, like, my patients from, you know, initial diagnosis through, where I sort of control the sequence, and most of them are coming from outside. And so I don't have control over, you know, how we sequence the therapy per se. So there are circumstances where people develop a really significant toxicity to prior checkpoint inhibitor, and so that limits their prior exposure, but most patients are over three for sure.
Well, I would like to thank Dr. Olson, Dr. Gibney, and Dr. Brockstein for being with us today. And for everybody who is here in person, thank you so much for coming, and if you're continuing to stay at ASCO and follow the meeting, be sure to check out our five-year oral data presentation on Monday, June second. So thank you!