BMYMP - Bristol-Myers Squibb Company (BMY) Management Presents at 2023 UBS BioPharma Conference (Transcript)
2023-11-12 06:47:05 ET
Bristol-Myers Squibb Company (BMY)
2023 UBS BioPharma Conference Transcript
November 8, 2023, 8:00 AM ET
Executives
Lynelle Hoch - Head, Cell Therapy
Analysts
Trung Huynh - UBS
Presentation
Trung Huynh
Okay. It’s 8 a.m. My name is Trung Huynh. I am one of the Therapeutics Analyst here at UBS. It’s my great pleasure to present to you guys, Bristol-Myers Squibb, for our first fireside session and conference. Today, we are talking about cell therapy for the next 45 minutes and for that we have got Lynelle Hoch, who is the Head of Cell Therapy at BMY and we have also got IR here in the room. Welcome.
Lynelle Hoch
Thank you. Great to be here.
Question-and-Answer Session
Q - Trung Huynh
It’s -- you guys are one of the pioneers of cell therapy.
Lynelle Hoch
Okay.
Trung Huynh
When I first looked at cell therapy, I thought to myself, oh my god, this is not going to work.
Lynelle Hoch
Yeah.
Trung Huynh
And there were many challenges, challenges around manufacturing, challenges around vector, supply, reimbursement. You guys have made significant progress over the last five years to try to address all of these issues. But perhaps can you talk about your progress today, where we are and what else do you think there needed to be done?
Lynelle Hoch
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 in T cells, with quite interested in getting access to that modality, because we had spent our time mostly in checkpoint inhibitor.
And so, clearly, cell therapy is something we are intrigued, but we have the same reservations and we had our list of things, you are saying. Will these things make it over regulatory hurdles, would they be reimbursed, all the manufacturing capacity, would they be truly as deep and durable as we were seeing in early datasets, and of course, as you kind of roll the clock forward to where we are today, well, it’s not complex free.
What, I would say to you is that, the transformational nature and the deep durable response we are seeing is real. I mean, you can see across multiple hematologic malignancies and we are excited about the promise of what it can do and other areas in the autoimmune, we will talk about that a little later.
But -- and when it comes to some of the challenges we faced 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 and 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, that we are today to be able to accelerate our pipeline with knowhow.
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 accelerate in our own pipeline, but truly be a partner of choice in cell therapy, because of that knowledge base that we have.
Trung Huynh
And you have certainly made a lot of that progress within the U.S. It feels like the awareness is there. Globally, though it does feel like perhaps you are bit behind, is 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…
Lynelle Hoch
Yeah.
Trung Huynh
… and in Europe?
Lynelle Hoch
Yeah. We look at market through two prisms. One, of course, we look at what is their infrastructure and knowhow 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 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 our CAR-T, because these first generation autologous programs, as you can imagine are complex, highly manual processes, which means they are expensive to actually manufacturer and it’s really, really important that we get value for the transformational result we are putting for patients.
And so the second prism, which country is really do value, that innovation and so I think in the early days of autologous cell therapy, I think, the first prism was multiple people and multiple folks who tried to go abroad and lot of countries want to delivery 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 the United States and 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 of course, we will be bring in our second-gen assets, which we have much more optimized manufacturing process and we feel we can reach our into those broader countries, but there is no question, the U.S. is a far more penetrated market for CAR-T and obviously that’s where we have majority of our business today.
Trung Huynh
And 2024 in terms of capacity, where are we for the U.S., in particularly, but do you have that. Where are we today with the capacity actual as well?
Lynelle Hoch
Yeah. I can speak again at a high level here on two prisms. One, listen, when we think about capacity, we think about in two buckets. We think about it from a vector capacity, I mean, do we have the vector, I think, you all know that we actually have acquired a vector facility out in Chicago with purpose of doing two things.
One, to internalize vector. It’s been fairly public that our -- many of our struggles particularly Breyanzi was we were vector constraint. 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 technology, because right now we are on adherent went to Biovector, it’s a low yield high up price process, where we moving towards is more of a suspension vector over time, we will be there first with Abecma and that actually is a much high yield lower cost base.
So that’s -- that was goal number one, is to get our vector supply under control and we are very confident that we are already there on Abecma, and we will be in a much better position next year in 2024 for vector and that’s for supply around the world.
Trung Huynh
Yeah.
Lynelle Hoch
The second is -- the second prism is drug product capacity. So as you know, we have 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 approval for Breyanzi in Massachusetts -- in Devens, Massachusetts.
We will soon be opening up our fourth state of the art facility in Devens, I am sorry, in Leiden in the Netherlands. So that will be our first European facility and we are also exploring facilities in Japan, because right now, we use third-party 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 share 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 and CLL, follicular and MCL. So we feel very good about our capacity built in the United States.
Trung Huynh
Great. And if we move on to the two products that you have on the market. You guys are pioneers, you are the only company with two cell therapies that target two different targets. One of the things, you can clearly see, you are making a big push to get these products used more. I think 20% to 30% of eligible people for CAR-T are using CAR-T. So you have got -- shown in many studies in the earlier stages. So perhaps for both of those products, can you summarize some of the data that you have seen and what makes you excited about pushing these products further up the treatment algorithm?
Lynelle Hoch
Yeah. Let’s start with Breyanzi. I mean, it’s our best-in-class CD19 targeted CAR-T. Obviously, initially launching in third line LBCL. We had through our transcend data, a really deep, durable remissions in United States, allowed us 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 a broadest label because we are across transplant ineligible, as well transplant eligible. So and we are being recognized for that. So, if you look at our business today the -- our business is now split 60-40 across second- and third-line LBCL and our fastest growing segment in 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 mattered more and more.
I mean, these patients they want to make sure they have the totality of the 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, as you think this is where we are 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 are the only company with many positive pivotal data, giving us a broad 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 are 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 this deep responses and durable responses. But this is a high unmet need area, where there is no option 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 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 are 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, 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, we -- long waitlists, patients expiring, we were not able to meet the demands of the market. We are -- 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 patients -- quality of the patient material coming to you and the fact that we now are unconstrained from a vector and DP. And I look at the asset both from the KarMMa data, real world data, as well as KarMMa-3, we have seen transformational results on the populations we have studied.
But it’s also -- we have got to be transparent. 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 by first, the entrance of T cell engagers took the bolus of patient, there nobody was on those waitlists 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 incident space, so now you were going fighting pain kind of patient-by-patient. And I think this is where, looking across the CAR-T’s, 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 are embarking on through multiple different levers, both in site expansion, a good clear understanding and articulation of our data. For example, at IMS, for those of you don’t know, it’s a conference, it’s held in different spots internationally, this year was in Greece in September.
And there were data presented there, that showed for KarMMa-3, when you use aggressive bridging for Abecma, like you have seen for Carvykti as a standard protocol for them in all their trials, when you looked at the sub-population of patients that were heavily bridged, you saw significant differences in the PFS. You are now more in that two-year range.
And so there is a clear learning here on CAR-T’s in multiple myeloma. One, understanding the population that you are treating. And number two, aggressive bridging therapy is really important, especially when you think about the time from an apheresis for ultimate infusion. So clearly some good learnings and I think that will -- those learnings will be something we will have to make sure we continue to educate physicians on.
Trung Huynh
Yeah. I think sequencing is certainly one of the big questions that I get, given the fact that it’s such a competitive market. 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 have seen with Legend and you are going to be releasing some data in the very early lines soon, in the next few years. All physicians using CAR-T as, maybe an induction therapy, something to swap out the stem cell transplant. How is your view about sequencing of…
Lynelle Hoch
Yeah.
Trung Huynh
… in the very early stages?
Lynelle Hoch
I think, couple of things about the U.S. I think it’s one of the most aggressive markets and it’s a place where they introduced triplet clause [ph]. And I do think folks are going to want to use CAR-T and we know that into earlier lines.
It’s a highly fragmented marketplace where there’s places for CAR-T’s in late lines, kind of mid-space and into earlier lines, 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, KarMMa-3, we -- the that design of that study was one where we understood that there is a high unmet need in triplet refractory exposed and DARE refractory for patient populations.
We knew that unmet need was super high and that is a place where CAR-T’s can have a great benefit and that’s what we have heard from thought leaders, that this is an area where more and more patients getting exposed to DERA earlier lines. It’s a 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 earlier lines, obviously, we are 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 are right. I think the U.S. marketplace and how they potentially will sequence these is 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 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 -- having a T cell engager prior is difficult for those patients to get and their 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 BCMA targeted T cell engager. So that sequence is really important. I think what needs to emergence is even earlier, what does that sequencing look like.
Trung Huynh
Yeah. Yeah. That’s really interesting. And we have a bispecific GPRC5D. You have a CAR-T GPRC5D in development. Can you perhaps talk a little bit about what you have seen with that product and…
Lynelle Hoch
Yeah.
Trung Huynh
… where we are and the next steps we should look out for?
Lynelle Hoch
Yeah. Hopefully. You have an opportunity to see our data that was presented for 65 patients on our GPRC5D asset at EHA. And the reason, we were excited about this was two fronts. One is the understanding and this was a target that people wanted to understand. If you can -- if you hit that target, what would be the tox profile? I think people believed you were going to see efficacy. I don’t think there was a question…
Trung Huynh
Yeah.
Lynelle Hoch
… 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 the -- our data shows, which was really kind of the shock and awe at EHA was this notion of on target, off-tumor, tox profile. When you are on an ongoing basis hitting that target, you have a lot more off-tumor tox.
And that’s clearly what we are seeing when you look at the profile T cell engagers that are targeting GPRC5D versus CAR-T. So we are 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 am sorry, on target, off-tumor side effects. So we are quite excited about that and equally 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. So this is the notion of hitting BCMA and GPRC5D in one CAR. And again, the thought process here is, you will get a broader set of patients that you can make an impact to 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 have seen in early data, not only are we going to 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 NAIVE, because if you saw the data from EHA, the drug looked equally as good in a BCMA Naïve, as well as -- but we feel by the time we launch this asset.
There will be a heavy BCMA penetration and exposure for patients and there will be a high unmet need in post-BCMA, which is why we are primarily positioning the GPRC5D as a post-BCMA. But, clearly, our dual targeting CAR will be looking in both populations.
Trung Huynh
Yeah. Understood. And you are doing that with your NEX T -- NEX T generation program, perhaps, it’s something that investors keep talking to me about. They are excited on what you are going to bring through next. Perhaps, can you talk about this program as a whole and what you hope to achieve from it in terms of manufacturing, engineering? What’s -- why this pushing the envelope?
Lynelle Hoch
Yeah. So our CD19 NEX T program is a program that we have accelerated into autoimmune. So we are quite excited about the promise of what a CAR-T targeting CD19 can do and but I will touch on that part, you talked about first, from a manufacturing process.
We really feel, we have a Goldilocks approach. You hear a lot about fast CARs, this notion of one-day to two-day manufacturing process. I am putting very naive T cells and allow for in Ex-Vivo T cell expansion for patients.
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 had a hard time either hitting dose or a lot of added spec, when you have very short and when you think about what customers want, they want to make sure they have a fast product that’s in spec.
And so what we feel we have found at our NEX T program is a minimally expanded Ex-Vivo T cell process where you basically shorten the manufacturing process, down from the seven-day to 10-day Ex-Vivo T cell expansion down to three-day to five-day and then you -- so, essentially, what this means for us is we are seeing high manufacturing success rates, along with what we think is a very fast manufacturing process.
So we are quite excited about that and this comes back to my point about when you are a company that has a ton of learnings and understandings and 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 certain segments of B cell, autoimmune disorders is just extraordinary. Now, early days, and certainly, these profiles will further be understood in the next few years.
But I have to tell you, when you think about what we are seeing in the first 50 patients, and when I say 50 patients, if you look at all the proof of concepts from Georgette’s data and other data sets, and you look at those in totality, what we are seeing is pretty impressive B cell Aplasia, which means that these patients off therapy are getting deep, durable remissions in diseases like lupus and scleroderma, myositis.
And from our standpoint, what that can tell you is that, these patients who were going to deteriorate over time, 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 their immune system by hitting some of those early precursor pro B cells and ablate those, and ultimately, reset the immune system. I think you are going to see a field where -- and you already are seeing it, there’s 16 companies racing into the space.
But I do think we feel very uniquely positioned for two reasons. One, the extraordinary learning, 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 and safety is going to 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 Georgette, 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. I think that says a lot, when the world renowned thought leader in this space has put his commitment and his efforts behind this asset.
So we are quite excited. As you know, we have our first R&D was in SLE. We have quickly moved and just recently announced our second green lights on R&D in IMF, I am sorry, in MS. And of course, as shared at our R&D Day, we also are looking at myositis and scleroderma as our first four B cell mediated autoimmune disorders that we will go after.
Trung Huynh
Yeah. Very, very exciting. And I think, we saw some more data from a group an abstract in ASH, which is randomly presenting lupus data at ASH.
Lynelle Hoch
Yeah.
Trung Huynh
But -- yeah, that data shows the durability of this approach. Really interesting.
Lynelle Hoch
Yeah.
Trung Huynh
And you are talking about the diseases that you are going to, 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?
Lynelle Hoch
Yeah. So there was 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.
Trung Huynh
Okay. And have you spoken to rheumatologists, neurologists about using CAR-T.
Lynelle Hoch
Yeah.
Trung Huynh
… oncologists always push the envelope. They are very -- they adopt technology very quickly. But rheumatology and neurologists that take a bit more time. So have you spoken to that appetite in using something like a CAR-T therapy?
Lynelle Hoch
Yeah. And I actually also want to make sure I come back to the 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 super important.
But to your point about rheumatologists, 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 are thinking about lymphodepleting in any regard. I mean would have to be doing that for a CAR-T.
But I think the other thing that’s becoming clearer and clear, the excitement is growing. The idea for them, as anything in life, when you say to someone, here’s all the talks, and they are like, well, I am 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 am 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 -- because of the drugs that they are on.
The idea that I could give them, an off-treatment, deep, durable remission. They now potentially can have a family and have a highly -- the skill tips. And so then the conversation shifts into, okay, I do want to talk about how I can be a part of this. How do I partner? How do we pick the right patients, as a patient selection, how do we prepare those patients?
Because it’s a very different conversation when you are recruiting the population. They are younger and they have big aspirations. But you also have to remind them that what you are going to go through is something that they have to be a partner with the position 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 what we would consider a manageable tox profile, I think not only will they be excited, I think patients will also be wanting kind of an opportunity for that.
Trung Huynh
Yeah. Yeah. And you mentioned the lupus stuff and ASH, what are your thoughts on that data?
Lynelle Hoch
So, listen, I think, it continues to corroborate what we saw in the early data from Georgette that you are basically seeing this B cell Aplasia, these deep, durable remissions. Of course, we all want to see this kind of in a broader set of patients and that’s what we will ourselves 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 other B cells…
Trung Huynh
Yeah. Okay.
Lynelle Hoch
…be it our new source.
Trung Huynh
And the next set of catalysts, we should be aware of, when are these starting, have they started, when is the best data that we should see?
Lynelle Hoch
Yeah. So we are not getting into details of when you will see that. I can tell you we are recruiting and you guys do a lot of discussions with different thought leaders. So we are aggressively recruiting for our trials and so we hope as 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 I can tell you we are quite aggressively moving here.
Trung Huynh
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 allergenic. So just…
Lynelle Hoch
Yeah.
Trung Huynh
… what’s BMS, as pioneers in this space, where are you now?
Lynelle Hoch
Yeah. So a lot of extraordinary work going on, as you can imagine, in a couple spaces. One, as you said, is how do we actually bring, was kind of all this living therapy, autologous cell therapy benefits, but also know some of the challenges into more of off the shelf solution? So we are looking at that from two ways, one is healthy donor derive allo and also we are looking at it from the IP/SCs, who are partnership with Century.
And 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, 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 HC allo program for lymphoma and so we are quite excited to see that continue to progress.
I think IP/SCs are further out. I think that that has not progressed as quickly as a field as we would have liked and so I do think the off-the-shelf solutions that will be, first the market, will be the HC allo program.
Trung Huynh
And do you have a preference, what’s the difference between a healthy donor approach versus an IP/SC. What’s the benefit do we get from…
Lynelle Hoch
Well, you can scale with an IP/SC much greater. I mean, you are talking from a healthy donor. You go from one to 100. There you go to 1000, it becomes more monoclonal antibody, like, I always say to people, like, that’s where you get the biologic, like when you get the IP/SCs.
And I think that, like I said, that would it’s kind of scale, durability and costs that are very different between the two. But clearly, where you are with the autologous and where you are with HC allo, you still get an advantage of scale that you don’t get with autologous.
Trung Huynh
And what are your thoughts about the Holy Grail of moving into solid tumors with some of these new approaches…
Lynelle Hoch
Yeah.
Trung Huynh
… while everyone hopes to come from the field, where are we today?
Lynelle Hoch
Yeah. So, listen, I think, if you look at the field holistically, it’s promising, because we are starting to see responses in tumors that we would not have seen to late-stage gastric and pancreatic. So you are 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 hematological, 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 biologic 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 that, I wish it was faster than it is today, but I actually feel we are going to see great progress over this next decade in solid tumor, because many companies have multiple shots on goal.
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 smart people across the ecosystem, academia, to industry, we will find kind of what is the two or three things that are going to work in solid tumor and I do feel we are going to see that progress further.
Trung Huynh
I wanted 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.
Lynelle Hoch
Yeah.
Trung Huynh
You are developing it in various different areas and you are doing extremely well in cell therapy. Just where are we today with access and reimbursement?
Lynelle Hoch
Yeah. When someone sits there and we look at the class penetration, and in multiple myeloma, it’s almost at 25%, in lymphoma depending online it’s around 10% 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 have been able to articulate under this notion 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 will 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 have 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.
Trung Huynh
Yeah.
Lynelle Hoch
And 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 are affiliated with is going to be the key.
And I do think we are uniquely positioned both with Breyanzi. We are 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 are putting a significant amount of effort, because it’s not only the community physicians, I should add, it’s the patients, like patients don’t always want to travel two hours to 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 home.
Trung Huynh
Yeah. That’s really interesting. It’s funny, when I talk to investors, it’s always, who’s got the better data, who’s going to win out here? It’s almost, given the fact that there’s many now players within cell therapy, it’s like a rising tide lift all boats…
Lynelle Hoch
Yes.
Trung Huynh
And to get that awareness up actually will benefit everyone else.
Lynelle Hoch
Yes.
Trung Huynh
So moving into the outpatient setting is key. And where are we today with outpatients versus in-patients and that should alleviate sort of concerned over capacity and space?
Lynelle Hoch
Yes. Yeah. So BMS is right now is about 20% outpatient. Obviously, we are going to be putting more efforts there now that we are unconstrained -- moving into an unconstrained mode, I should say.
Where we have 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.
Trung Huynh
Yeah. Okay. We have got five minutes left. Has anyone in the audience got any questions? Okay, so to finish up, sort of in the next 10 years, what do you hope to have achieved in your time at the Head of Cell Therapy? Where can we be in 10 years’ time?
Lynelle Hoch
Yeah. I think when I look back a decade, where autologous cell therapy was given to a handful of patients and certainly the promise is extraordinary. Where we are today, where we are treating 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-T 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, a young woman in her 30s and have her story be told that she took a risk going on to a pretty probably scary trial as far as she’s concerned and had her life completely changed. So that’s what I hope for.
Trung Huynh
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 a rest of -- a good rest of day.
Lynelle Hoch
Thank you so much, Trung.
Trung Huynh
Excellent. Thank you.
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Bristol-Myers Squibb Company (BMY) Management Presents at 2023 UBS BioPharma Conference (Transcript)