Okay, it's 8:00 A.M. My name is Trung Huynh. I'm one of the therapeutics analysts here at UBS. It's my great pleasure to present to you guys Bristol- Myers Squibb. It's our first five slide session in our conference. Today we're talking about cell therapy for the next 45 minutes. And to the - we've got Lynelle Hoch, who is the head of cell therapy at BMY, and we've also got IR here, sat in the room. Welcome.
Thank you. Great to be here.
Well, it's you guys are one of the pioneers of cell therapy. When I first looked at cell therapy, I thought to myself, "My God, this is not going to work.
Yeah.
There were many challenges. Challenges around manufacturing, challenges around the vector, supply, reimbursement. You guys have made significant progress over the last five years to try to address all of these issues.
Yeah.
But perhaps can you talk about your progress today?
Yeah.
Where we are, and, you know, what else do you think there's needed to be done?
Yeah, let me double-click on that commentary you just said. We go back to when BMS was looking at the acquisition of Celgene, and one of the crown jewels of that acquisition was to go after cell therapy. Obviously, a company that had a keen understanding of the power of the immune system, and T cells was quite interested in getting access to that modality because we had spent our time mostly in the checkpoint inhibitors. And so clearly, cell therapy was something we were intrigued, but we had the same reservations, and we had our list of things saying, "Would these things make it over regulatory hurdles? Would they be reimbursed?" All the manufacturing complexities.
Would they be truly as deep and durable as we were seeing in early data sets?" And of course, as you kind of roll the clock forward to where we are today, well, it's not, you know, complex free. What I would say to you is that, the transformational nature and the deep, durable response we're seeing is real. I mean, you can see across multiple hematologic malignancies, and we're excited about the promise of what it can do in others areas in the autoimmune, and we'll talk about that a little later. But - a nd when it comes to some of the challenges we face on manufacturing and vector, yes, it took time. It was not as quick as some of the solutions we would typically apply in monoclonal antibodies or small molecules.
But once you build that capability, both in your kind of manufacturing as well as in your vector capabilities, this does afford you to be in a position so that we are today, to be able to accelerate, you know, our pipeline with know-how, because we have probably more manufacturing, translational, and clinical data than anyone else in the world in cell therapy. And it does afford us to be not only accelerating our own pipeline, but truly be a partner of choice, in cell therapy because of that knowledge base that we have.
You've certainly made a lot of that progress within the U.S. It feels like, you know, the awareness is there.
Mm-hmm.
Globally though, it does feel like perhaps you're a bit behind with that awareness. So perhaps can you give us sort of your view on where we are today in the U.S. versus where we are today globally and In Europe.
Yeah, we, we look at markets through two prisms. One, of course, we look at what is their infrastructure and know-how to deliver cell therapy? Because you can't deliver cell therapy unless you have qualified CAR T centers, and not every country has that infrastructure. So, so that's the first prism that we look through. And then, the second prism we look through is to understand the value they will put on these transformational results and on a CAR T, because these first generation autologous programs, as you can imagine, are complex, highly manual processes, which means they're expensive to actually, manufacture. And it's really, really important that we get value for the transformational results we're putting for patients. And so the second prism is, which countries really do value that innovation?
I think in the early days of autologous cell therapy, I think the first prism was that multiple people and multiple folks tried to go out broad. A lot of countries want to deliver CAR T, but don't have the infrastructure or the regulatory environment to be able to do so. And I think where we are today, I think we feel confident now that our footprint being in the United States, the main countries in Europe as well as Japan, that we can now build our capabilities and infrastructure from a manufacturing as well as scale out.
And then, of course, we'll be bringing in our second-gen assets, which we have, you know, much more optimized manufacturing process, and we feel like we can reach out into those broader countries. But there's no question the U.S. is a far more penetrated market for CAR T. And obviously, that's where we have the majority of our business today.
For 2024, in terms of capacity, where are we for the U.S. in particular, but do you have that - w here are we today with that capacity ex U.S. as well?
Yep. I can, I can speak, again, at a high level here on two prisms. One, listen, when we think about capacity, we think about it in two buckets. We think about it from a vector capacity. I mean, do we have the vector? And I think you all know that we actually have acquired a vector facility out in Chicago with the purpose of doing two things. One, to internalize vector. It's been fairly public that our many of our struggles, particularly on Breyanzi, was we were vector constrained.
We were dependent on third parties, and they were not able to keep up with the capacity. So we made the decision to internalize vector in part as a dual sourcing strategy, both internal and external, as well as accelerate to next-gen technologies. Because right now we're on adherent lentiviral vector. It's a low yield, high price process. Where we are moving towards is more of a suspension vector over time. We'll be there first with the Abecma. And that actually is a much higher yield, lower cost base. So that was goal number one, is to get our vector supply under control, and we're very confident that we're already there on Abecma, and we'll be in a much better position next year in 2024 for vector, and that's for supply around the world.
Yeah.
The second is, the second prism is drug product capacity. So as you know, we have, you know, three state-of-the-art facilities opened up now, one in Seattle, Washington, the other one in Summit, New Jersey, and our third just opened and got FDA approved for Breyanzi in Massachusetts, in Devens, Massachusetts. We will soon be opening up our fourth state-of-the-art facility in Devens. I'm sorry, in Leiden, in the Netherlands. So that'll be our first European facility. And we're also exploring facilities in Japan, 'cause right now we use third parties for our Asia presence.
So when it comes to capacity, to answer your questions, in the United States, we are completely unconstrained on Abecma from both vector as well as DP. And for Breyanzi, we are going to be in a great position next year for vector. DP capacity has not been a challenge for Breyanzi based on the fact that we opened up Devens, and now we have three facilities providing capacity, and that includes our ability to support our potential three additional launches going into additional populations in CLL, follicular, and MCL. So we feel very you know good about our capacity build in the United States.
Great. If we move on to the two products that you have on the market y ou guys are pioneers. You're the only company with two cell therapies that target two different targets. One of the things you can clearly see is you're making a big push to get these products used more.
Mm-hmm.
I think 20%-30% of eligible people for CAR T are using a CAR T.
Mm-hmm.
So you've shown many studies in the earlier stages.
Mm-hmm.
Perhaps for both of those products, can you summarize some of the data that you've seen and what makes you excited about pushing these products further up the treatment algorithm?
Yeah. Let's start with Breyanzi. I mean, it's our, our best-in-class CD19-targeted CAR T. Obviously, initially launching in third-line LBCL, we had through our TRANSCEND data, really deep, durable remissions. And, you know, as, as a lot of folks talk about, this is kind of where you set the ground, as it relates to cell therapy with the CD19-targeted agents. We then had the good fortune of moving vis-à-vis TRANSFORM up into second line with the broadest label 'cause we are across transplant-ineligible as well as transplant-eligible. So, and we're being recognized for that. So if you look at our business today, Our business is now split 60/40 across second and third line LBCL, and our fastest-growing segment is second line. I think that's recognition of two things.
One, the significant efficacy that they see in Breyanzi, and number two, and equally important, as you move into earlier lines, the safety profile matters more and more. I mean, these patients, they want to make sure they have the totality of those deep, durable remissions that they expect from a CAR T, but they also want a safety profile that they can be confident in. And so I do think this is where we're seeing some nice further separation and differentiation on the Breyanzi profile. And then, of course, this was a big year, for Breyanzi. We now have. We're the only company with many positive pivotal data, giving us the broadest array of B-cell malignancies with the data that was, presented between ASCO, ICML, and EHA, when we presented data on CLL, follicular, and MCL.
So we're quite excited about the promise of what Breyanzi can bring. Because if you think about CLL, for example, clearly, it is a small population that where we saw these deep responses and durable responses, but this is a high unmet need area where there is no options for these patients. I can tell you the community is excited to hear and get access to the potential of that. And interestingly enough, many companies tried. There are other CD19-targeted CAR Ts that studied in CLL, but were not able to find success. So again, I think showing the differentiation of the Breyanzi construct, so we're quite excited about that.
So yes, there's no question, when we think about Breyanzi, it is our flagship asset, where we have great runway today on our current in-line indications, and potential as we become unconstrained, because that is what's been holding us back, is constraint, not demand for the asset. And then as I think about adding on these, incremental opportunities for an LCM, we really have seen great promise, in Breyanzi in 2024 and beyond. When it comes to Abecma, you know, this is the first multiple myeloma BCMA-targeted CAR T. I think it's been on quite a journey. If I go back to when I first started this role, we were in the midst of a launch where it was really difficult discussions. Long wait lists, patients expiring, we were not able to meet the demands of the market.
Our CAR T was put on very, very sick patients, patients that were close to expiring. And so as I go from those days to where we are today, where we have a 94% manufacturing success rate and a very hard population to have that based on the patient quality of the patient material coming to you, and the fact that we now are unconstrained from a vector in DP. And I look at the asset, both from the KarMMa data, real-world data, as well as KarMMa-3, we've seen transformational results on the populations we've studied. But it's also, we've got to be transparent. It's a, it's a highly competitive multiple myeloma marketplace.
And I think that is what you saw and heard from us on our earnings call, the competitive nature of multiple myeloma, both first by the entrance of T-cell engagers took the bolus of patients out there. Nobody was on those wait lists anymore. Physicians had no need to wait for a CAR T because they had something at their disposal. So you saw the first bolus went away, and then you became competitive on an incumbent space. So now you're going, fighting kind of patient by patient. And I think this is where, you know, looking across, you know, the CAR Ts as well as the T-cell engagers, it's clear that we have work to do to ensure the competitive position for Abecma.
And that's the work that we're embarking on through multiple different levers, both insight expansion, a good clear understanding and articulation of our data. For example, at IMS, for those of you who don't know, it's a conference, it's held in different spots internationally. This year was in Greece in September, and there was data presented there that showed for KarMMa-3, when you use aggressive bridging, for Abecma, like you've seen for CARVYKTI as a standard protocol for them in all their trials. When you looked at the subpopulation of patients that were heavily bridged, you saw significant differences in the PFS. You're now more in the, that two-year range. And so there is a clear learning here on CAR Ts in multiple myeloma.
One, understanding the population that you are treating, and two, aggressive bridging therapy is really important, especially when you think about the time from an apheresis to ultimate infusion. Clearly some good learnings, and I think that will - t hose learnings will be something we'll have to make sure we continue to educate physicians on.
Yeah. I think sequencing is certainly one of the big questions that I get, given the fact that it's such a competitive market.
Mm-hmm.
So, are you seeing a shift in physicians in the U.S. in terms of how aggressive they treat multiple myeloma? Some of the data we've seen with Legend, and you're going to be releasing some data in the very early lines soon, in the next few years. You know, are physicians using CAR T as maybe an induction therapy or something to swap out for stem cell transplants?
Mm-hmm.
How's your view about sequencing of in the very early stages?
I think a couple of things about the U.S. I think it's one of the most aggressive markets, and it's a place where they introduce triplets, quads, and I do think folks are gonna want to use CAR Ts, and we know that, into earlier lines. It's a highly fragmented marketplace, where there's places, for CAR Ts in late lines, kind of mid-phase and into earlier lines. Now obviously, the data will have to play out into earlier lines, and replacing transplant is quite a journey as far as how much time it will take for data readouts in that space.
But what I can tell you, when I think about like, you know, KarMMa-3, t hat design of that study was one where we understood that there is a high unmet need in triple refractory exposed and dara-refractory patient population. We knew that unmet need was super high, and that is a place where CAR Ts can have a great benefit, and that's what we've heard from thought leaders, that this is an area where more and more patients getting exposed to dara earlier lines, that the heavy trend in the United States, having a drug that they can use in those patients, the refractory is super important. And then as far as early lines, obviously, we're you know, intrigued and excited about KarMMa-9, vis-à-vis our KarMMa-2 data, where we basically saw significant durable responses to patients who did not receive a CR from transplant.
And again, that is another area of high unmet need, where patients who do not respond to a transplant, where do they go? And it does seem, again, early days in the data, but from KarMMa-2, that these patients are responding to a CAR T cell, and obviously getting deep, durable responses. So I think you're right. I think the U.S. marketplace and how they potentially will sequence these is, it's super important and something that's still evolving. I can tell you in late line, it's almost to a TL.
They feel very strongly to use a CAR T before a T-cell engager, and that the reason they feel that way is the T-cell exhaustion and the quality of those T-cells. For you to get the optimal T-cell response from a CAR T, you really - h aving a T-cell engager prior is difficult for those patients to get. There's data that has been shown both at ASCO and further emerging, showing that you get a very different durability to a CAR T if it's sequenced before or after a BCMA-targeted T-cell engager. So, that sequence is really important. I think what needs to emerge is even earlier, what does that sequencing look like?
Yeah, yeah, that's really interesting. You know, we have a bispecific GPRC5D.
Mm-hmm.
You have a CAR T GPRC5D in development. Can you perhaps talk a little bit about what you've seen with that product and where we are, and what's the next steps we should look out for that?
Yeah. Hopefully, you have an opportunity to see our data that was presented for 65 patients, our GPRC5D asset at EHA. And, and the reason we were excited about this was two, two fronts. One is the understanding, and this was a target that people wanted to understand. If you can - i f you hit that target, what would be the tox profile? And people believed you were going to see efficacy. I don't think there was a question whether that target was relevant, in multiple myeloma, and whether you would get deep, durable responses.
I think the question was really on the safety profile, and I think this is the beauty of a CAR T. Because what our data show, which was really kind of the, you know, shock and awe at EHA, was this notion of on-target, off-tumor tox profile. When you're on an ongoing basis hitting that target you have a lot more off-tumor tox, and that's clearly what we're seeing when you look at the profile of T-cell engagers that are targeting GPRC5D versus CAR T. So we're quite excited to see that you get that deep, durable response by hitting that target once, but do not get that same level of off-target. I'm sorry, on-target, off-tumor side effects. So we're quite excited about that.
And equally, we're - yeah, obviously that program is moving very quickly. That's going into pivotal. The other program that will be going into clinic this year is our dual-targeting CAR.
Yeah.
So this is the notion of hitting BCMA and GPRC5D in one CAR. And again, the thought process here is you'll get a broader set of patients that you can make an impact with those deep, durable responses. And we really wanted to understand the tox profile first, the 5D, before we combined them, and now seeing what we've seen in early data, not only are we gonna accelerate the GPRC5D program, primarily focused on post-BCMA, by the way.
I know a lot of our TLs are pushing us in the BCMA-naïve, because if you saw the data from EHA, the drug looks equally as good in a BCMA-naïve as well as - b ut we feel by the time we launch this asset, there'll be a heavy BCMA penetration and exposure for patients, and there'll be a high unmet need in post-BCMAs, which is why we're primarily positioning GPRC5D as a post-BCMA. But clearly, our dual-targeting CAR will be looking in both populations.
Yeah, understood. And you're doing that with your NEX-T, next-generation program. Perhaps it's something that investors keep talking to me about. They're excited-
Mm-hmm.
On what you're gonna bring through next. Perhaps can you talk about, you know, this program as a whole, and what you hope to achieve from it in terms of manufacturing, engineering? What... Why is this pushing the envelope?
Yeah, so our CD19 NEX-T program is a program that we have accelerated into autoimmune. So we're quite excited about the promise of what a CAR T targeting CD19 can do. But I'll touch on the part you talked about first from a manufacturing process. We really feel we have the Goldilocks approach. You hear a lot about fast CARs, this notion of a 1-2-day manufacturing process, putting very naïve T cells and allow for in vivo T cell expansion for a patient. And what we have found in the work we did with our NEX-T BCMA program, and we applied it to our NEX-T CD19 program, was what you would have there was you'd had a hard time either hitting dose or a lot of out of spec when you have very short.
When you think about what customers want, they wanna make sure they have a fast product that's in spec. So what we feel we have found in our NEX-T program is a minimally expanded, ex vivo T cell process, where you basically shorten the manufacturing process down from these 7-10 day ex vivo T cell expansion down to three to give and then you infuse. So essentially, what this means for us is we're seeing high manufacturing success rates, along with what we think is a very fast manufacturing process. So we're quite excited about that, and this comes back to my point about when you're a company that has a ton of learnings and understandings and things, that we had the opportunities to get those learnings from our BCMA NEX-T program that we applied here.
But more than the manufacturing process, I have to tell you, the idea that we could potentially cure, you know, certain segments of B-cell autoimmune disorders is just extraordinary. Now, early days, and certainly with these profiles will further be understood in the next, you know, you know, few years. But I have to tell you, when you think about what we're seeing in the first 50 patients, and when I say 50 patients, if you look at all the proof of concept from Georg's data and other data sets, and you look at those in totality, what we're seeing is pretty impressive B-cell aplasia, which means that these patients off therapy are getting deep, durable remissions in diseases like lupus and other, you know, scleroderma, myositis.
From our standpoint, what that can tell you is that these patients who were going to deteriorate over time, you know, if you think about severe lupus, these are patients that would go on to have organ failure, high morbidity, mortality, and just a poor quality of life. So if you can go in with a CD19-targeted CAR T and be able to reset the immune system by hitting some of those early precursor pro-B cells, and ablate those, and ultimately reset the immune system, I, I think you're, you're gonna see a field where - and you already are seeing it. There's 16 companies racing into this space.
But I do think we feel very uniquely positioned for two reasons. One, the extraordinary learnings I spoke about. But two, the construct of our CD19 is Breyanzi. So you have an asset that we have a strong understanding of from its efficacy and safety profile.
Mm-hmm.
And safety is gonna matter quite a bit, as you can imagine, in these disease areas. But we put it into a single train. We no longer separate CD4s and CD8s, so we pulled that into a single train process for our CD19 program and put it on this optimized manufacturing process that we just discussed. So we feel quite excited, and this is why Georg Schett, who's the world-renowned thought leader in this space, he advises many companies, but he wanted to be a lead PI on one asset, and he chose our CD19 NEX-T. So I think that says a lot, when the world-renowned thought leader in this space has put his, you know, commitment, and his efforts behind this asset. So we're, we're quite excited. As you know, our first IND was in SLE.
We quickly moved and just recently announced our second green light on IND and IMS, or I'm sorry, in MS. And of course, as shared at our R&D date, we also are looking at myositis and scleroderma as our kind of first four B-cell-mediated autoimmune disorders that we'll go after.
Yeah, very, very exciting, and I think we saw some more data from a group, at an abstract in ASH, which is randomly presenting lupus data at ASH, but, you know.
Yes.
But yeah, it - t hat, that data showed the durability of this approach. Really interesting.
Yeah.
You know, you're talking about the diseases that you're going into, a lot of B-cell-mediated diseases. How about T-cell mediated diseases? What's your thoughts about using a CAR T to treat those?
Yeah. So there is clearly interplay between B-cell and T-cell mediation, and we are certainly watching it. I think our early thought process is all the proof of concept so far has been in B-cell mediated. And so the thought process for us is, let's focus in these areas where we know that there's high unmet medical needs, continue to understand the interplay between B-cell and T-cell mediated, but at this point, our feeling is where there is the strongest proof of concept is clearly in this notion of B-cell-mediated autoimmune disorders.
Okay. And have you spoken to rheumatologists, neurologists about using CAR T?
Yeah.
Oncologists always push the envelope. They're, you know, they adopt technology very quickly. Rheumatology and neurologists, they take a bit more time. Have you spoken to their appetite in using something like a CAR T therapy?
Yeah, and I actually also wanna make sure I come back to an interesting comment you said that it's interesting that at ASH there is going to be data in autoimmune because I will come back to that because it is interesting the amount of excitement for autoimmune, even in the hematology space. Because they understand they are going to be most likely the people infusing the CAR T, and therefore their partnership with rheumatologists and neurologists is gonna be super important. But to your point about rheumatologists and most, it's no question that they have a higher quote-unquote "expectation" around the overall profile and particularly around the safety. I mean, these are not patients that you're thinking about lymphodepleting in any regard, and would have to be doing that for a CAR T.
But I think the other thing that's becoming clearer and clearer, the excitement is growing. The idea for them, it's - as anything in life, when you say to someone, "Well, here's all the tox," and they're like: "Well, I'm never touching this." But then you show them the potential efficacy profile, and then all of a sudden, the risk-benefit tips and they start saying to themselves: "Okay, I'm thinking about these young women who have severe lupus, who have a lifetime of deterioration, potentially can't go on to have children, have other - b ecause of the drugs that they're on.
The idea that I could give them an off-treatment, deep, durable remission, they now potentially can have a family, and have a high degree - the field tips. And so then the conversation shifts into: "Okay, I do - I do wanna talk about how I can be a part of this. How do I partner? How do we pick the right patients?" And so, so patient selection. "How do we prepare those patients?" This is a very different conversation than when you're recruiting this population. They're younger, and they have big aspirations, but you also have to remind them that what you're gonna go through is something that they have to be a partner with the physician on. But I have to tell you, the growing excitement is palpable, with each one of those communities.
But really what will dictate, in my opinion, how penetrated this becomes and how much rheumatologists jump on board, or neurologists jump on board, is what the profiles emerge to be.
Because if you see profiles where you are seeing these very deep, durable remissions off therapy, with, you know, what we would consider a manageable tox profile, I think not only would they be excited, I think patients will also be wanting kind of an opportunity for that.
Yeah, yeah. And you mentioned the lupus stuff in ASH. What are your thoughts on that data?
So listen, I think it continues to corroborate what we saw in the early data from Georg Schett, that you're basically seeing this B-cell aplasia, these deep, durable remissions. Of course, we all wanna see this kind of in a broader set of patients, and that's what we'll, we'll continue ourselves and continue to accelerate to. But I have to tell you, I think it corroborates the theory that if you can go in and ablate these precursor B cells, you can potentially reset someone's immune system, which then, as I said, not only opens up the possibility in lupus, but any of these CD19 targeting, you know, other B-cell-mediated autoimmune disorders.
The next set of catalysts we should be aware of, when are these starting? Have they started? You know, when's the first data that we should see?
Yeah, so we're - we're not getting into details of when you'll see data. I can tell you we're recruiting, and you probably - I know you guys do a lot of discussions with different thought leaders. So we are aggressively recruiting for our trial. And so we, you know, hope that soon as we have a good set of data, we will make sure that that gets into the public domain, for obvious reasons. But yeah, so we - I can tell you we're quite aggressively moving here.
Okay. And then the final thing that we wanted to touch on was the non-viral delivery systems that you have on the horizon. What's BMS doing here? I mean, ever since we first started talking about cell therapy, there's been a discussion about allogeneic. So just-
Yeah.
What's BMS as pioneers in this space, where are you now?
Yep. So, a lot of extraordinary work going on, as you can imagine, in a couple phases. One, as you said, is how do we actually bring, you know, what was kind of all this living therapy, autologous cell therapy benefits, but also know some of the challenges into more of an off-the-shelf solution? So, we're looking at that from two ways. One is healthy donor-derived allo, so these. And also, we're looking at it from the iPSCs, through our partnerships with Century. So from our standpoint, what we really need to see here is we need to see not only responses, but durability and persistence, which is what has been evasive in the particularly the healthy donor-derived allo approaches. But we know that the field, and including us, are getting closer.
We are moving into clinic with our first HD allo program for lymphoma. And so we're quite excited to see that continue to progress. I think iPSCs are further out. I think that that has not progressed as quickly as a field as we would've liked, and so I do think the off-the-shelf solutions that will be first to market will be the HD allo programs.
Do you have a preference? What's the difference between a healthy donor approach versus an iPSC? What's the benefits you get from an iPSC?
Well, you can scale with an iPSC much greater. I mean you're talking from, you know, a healthy donor, you go from one to, you know, 100. There, you go to thousands. Like, it becomes more monoclonal antibody-like. I always say to people, like, "That's where you get to biologic, like, when you get to iPSCs." And I think that, like I said, so that would - i t's kind of scale, durability, and cost that are very different between the two, but clearly, where you are with autologous and where you are with HD allo, you still get an advantage of scale that you don't get with autologous.
What are your thoughts about the Holy Grail of moving into solid tumors with some of these new approaches?
Yeah.
It's what everyone hopes to come from the field. Where are we today?
Yeah. So listen, I think if you look at the field holistically, it's promising because we're starting to see responses in tumors that we would not have seen so late stage gastric and pancreatic, so you're seeing responses. I think the question is: Can we get durability to those responses? And as we know, the tumor microenvironment is far more difficult than in the hematologic, where you have a clean target, you can hit. So we are doing a lot with different technologies in gene editing to be able to help different logic gate approaches, all with the goal of not only getting to a target, but cleanly binding to that target, and then to get some durability to that.
So what I would say is I wish it was faster than it is today, but I actually feel we're gonna see great progress over this next decade in solid tumor, because many companies have multiple shots on goal. And as a matter of fact, if you take a step back and look at investments in cell therapy, almost 50% of it is in solid tumor, so there is no question that's where multiple people are pursuing. And I find when you have 50% of investments of very, you know, smart people across the ecosystem, of academia to industry, we will find kind of the what is the two or three things that are gonna work in solid tumor, and I do feel we're gonna see that progress further.
I want to take a step back and look at access and reimbursement and penetration. Ultimately, the goal is to get this product in as many people as possible.
Yeah.
You're developing it in various different areas and you're doing extremely well within cell therapy. Just where are we today with access and reimbursement?
Yeah, when someone sits there, and we look at the class penetration, and in multiple myeloma, it's almost you know, at 25%. In lymphoma, depending on line, it's, you know, you know, around ten to 20%. What holds us back is not market access. I think we all thought it was going to.
But I do think the value proposition we've been able to articulate under this notion of kind of these deep, durable responses that are treatment-free, is a very big benefit to payers, and they have been following the data. As you go into earlier lines, there'll be more duress on that, for sure. But again, I think the quality of the data will ultimately help preserve kind of unfettered access to CAR T, which is what we've enjoyed. I will say, I think the bigger rate limiter to penetration of class share sits in the community physicians who have these patients, who are not delivering CAR T.
Yeah.
Our ability to bring CAR T closer to the community will be the key. Our ability to bring CAR Ts, where community guys would maybe not have access to them, or at least not to an institution that they're affiliated with, is going to be the key. And I do think we're uniquely positioned, both with Breyanzi, we're the only one with actually a specific study, known as OUTREACH, to actually look at the drug in an outpatient setting, and also with Abecma's overall profile. These are CAR Ts that can be brought closer to home, and so I do think that is your bigger rate limiter, and I think that's where we're putting a significant amount of effort because it's not only the community physicians, I should add, it's the patient.
Like, patients don't always wanna travel two hours to, you know, commit a month of their life for not just getting the infusion, but actually being watched closely after their infusion. So I do think that will be the key of that next 5-10% of penetration, is how do you bring CAR T closer to home?
Yeah, that's really interesting. It's, it's funny, when I talk to investors, it's always who's got the better data, who's gonna win out here. Given the fact that there's many new players within cell therapies, like a rising tide lifts all boats and to get that awareness up actually will benefit everyone else.
Yeah.
So moving it into that outpatient setting, it, yeah, is key. And where are we today with outpatients versus inpatients? And that should alleviate concerns over capacity and space?
Yeah, so Breyanzi right now is about 20%, outpatient. Obviously, we're, you know, gonna be putting more effort there now that we're unconstrained, you know, moving into an unconstrained mode, I should say. Where we've been constrained, we have been very limited in our footprint, not just by country, but inside of a country. So we weren't able to push harder into the community. I think as we move into 2024 and become unconstrained, I think that will allow us to grow that number beyond that. And Abecma is a bit lower, it's about 15%, but again, this is a big area of effort, is to expand our footprint and bring it closer.
Yeah. Okay. We've got 5 minutes left. Is anyone in the audience got any questions? Right. Okay, so to finish up, sort of in the next 10 years, what do you hope to have achieved in your time at, you know at the head of cell therapy? Where can we be in 10 years' time?
Yeah, I think, you know, when I think back a decade, where autologous cell therapy was given to a handful of patients, and certainly the promise was extraordinary. And where we are today, where we're treating, you know, tens of thousands of patients collectively as an industry. We would love to see in 10 years that hundreds of thousands of patients are getting access to CAR Ts and are seeing transformational, life-changing results. And I'd love to see that in multiple disease areas, including ones that nobody would have ever thought there could be a possibility of a cure. And so for us, I mean, that to me, if I look back, I hope in 10 years, I can stand next to a lupus patient, you know, a young woman in her 30s, and have her story be told.
That she took a risk going onto a pretty, you know, probably scary trial as far as she's concerned, and had her life completely changed. Like, so, so that's what I hope for.
Well, excellent. Well, thank you very much for your time. It's very inspiring what you guys are achieving at the moment. And we hope you have a rest of the - a good rest of the meeting.
Thank you so much, really.
Excellent. Thank you.