Bristol Myers Squibb at Bernstein Forum: Cell Therapy Insights

On Tuesday, 23 September 2025, Bristol Myers Squibb (NYSE:BMY) presented at the Bernstein Insights: Healthcare Leaders and Disruptors - 2nd Annual Healthcare Forum. The discussion focused on the company’s strategic advancements in cell therapy, highlighting both opportunities and challenges. While Bristol Myers Squibb emphasized its leadership in cell therapy and promising developments, it also addressed hurdles such as limited CAR T therapy adoption.

Key Takeaways

• Bristol Myers Squibb has treated 13,000 patients with cell therapy, leveraging extensive clinical data.
• The company is optimistic about Orva-cel and Breyanzi, targeting autoimmune and neuroinflammatory diseases.
• Only 20% of eligible patients currently receive CAR T therapy, highlighting access challenges.
• Breyanzi is a leading CD19 CAR T therapy in the U.S., Germany, Japan, and France.
• Bristol Myers Squibb aims to expand CAR T delivery to community centers and increase patient access.

Financial Results

• Breyanzi has quickly become the top CD19 CAR T therapy in the U.S. and other major markets.
• The therapy has a significant milestone with an upcoming DUFA date for marginal zone lymphoma (MZL) in December.

Operational Updates

• Despite the potential, only 2 out of 10 eligible patients receive CAR T treatments.
• Bristol Myers Squibb is working to expand CAR T availability, with updates to REMS labels expected to progress slowly.
• The company has initiated trials of Allo CAR-T therapies targeting CD19 for autoimmune conditions.
• Community centers like Virginia Oncology and Tennessee Oncology are successfully administering CAR T, with efforts to expand to more centers.

Future Outlook

• Bristol Myers Squibb anticipates new data for Orva-cel in relapse refractory multiple myeloma next year.
• The company is targeting dual-targeting CAR Ts in newly diagnosed patients, with promising internal enthusiasm.
• Trials are ongoing for CAR T applications in immunology, with a focus on autoimmune diseases, which represent a larger population than hematology.

Q&A Highlights

• The Action Network of physicians is collaborating to develop clinical strategies and promote partnerships between rheumatologists and hematologists.
• Bristol Myers Squibb is accelerating its clinical development plans to enhance its position across various populations.

Readers are encouraged to refer to the full transcript for a detailed understanding of the discussions.

Full transcript - Bernstein Insights: Healthcare Leaders and Disruptors - 2nd Annual Healthcare Forum:

Courtney Breen, Large Cap Analyst, Bernstein: Thank you all so much for being here. Lynelle, thank you so much for being here with us today. For those of you who don’t know me, my name is Courtney Breen. I am the Large Cap Analyst here at Bernstein covering all of our U.S. names, Bristol included. I am very, very proud and happy to share the stage today with Lynelle here from Bristol. She is the Head of the Cell Therapy business. We’re going to have a bit of a conversation around particularly the potential in cell therapy, how it’s landing in the hematology space, predominantly where it is today, where it might be going in the future. I am really, really excited to talk about this because I think we’ve got some proof points now, but there’s a lot of innovation on the horizon, which is really, really exciting.

Perhaps before we dig into that, I’d love to hear, Lynelle, you just open with a couple of comments from your side. Anything you want to say to set the stage and set some context about your background and the conversation we’re going to have?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: First of all, thank you, Courtney, and thank you to Bernstein for having me and Bristol Myers Squibb represented here today. I’m excited to have a 40-minute conversation about cell therapy. I have passionately been involved in this particular business for four years. I think to myself, when I go back, when it all started for Bristol Myers Squibb, we embarked, we were launching the very first CAR T in multiple myeloma. We were going to be launching the third to market CD19 CAR T. There were a lot of unknowns.

There were unknowns about how durable would these CAR Ts be, would they be successfully able to move up into earlier lines, what was the access and reimbursement landscape really going to look like, how are you going to be moving it into global markets, and could you scale and scale in a way that could allow you to have a marketplace that was very viable. As we sit four years later, after treating 13,000 patients, we sit in a unique position at Bristol Myers Squibb where we have more manufactured clinical and translational data than almost anyone else in this space. It has afforded us the opportunity not only to grow our inline assets, but it’s helped us accelerate our pipeline.

I think now when I sit here, we have near-term best-in-class, first-in-class CAR Ts with our GPRC5D known as Orva-cel, our dual-targeting CAR BCMA and GPRC5D in multiple myeloma, as well as probably the asset that you guys mostly ask us about, which is our CD19 Breyanzi. For obvious reasons, the field is really excited because they want to know, are these deep, durable, treatment-free remissions with a one-time infusion, are they possible in diseases where functional cures were not even thought of three years ago? We’re really, really excited about the potential of what CAR T can bring to the autoimmune space as well as neuroinflammatory. For us, we’re super excited about cell therapy.

We understand some of the challenges with cell therapy, but we do believe we’re at a really important inflection point to bring the promise of cell therapy to more populations, more people as we continue to grow the class and move into other disease areas.

Courtney Breen, Large Cap Analyst, Bernstein: Fantastic. That is a perfect opening for where I wanted to start because I did really want to start on some of those market factors and kind of how the healthcare systems have potentially limited some of the use that perhaps if you look back 10 years, people were hoping to see by this point. There has begun to be enhanced utilization, but then we’ve also got bispecifics perhaps coming in and competing with the class as well in certain places. As you look forward 10 years into the future in the heme space, let’s just start there because there are many other places we can go. In hematology, the next 10 years, what does good look like in terms of the potential for cell therapies?

What unlocks are really important in terms of the healthcare system, be it access, be it the way that the system works to ensure that these patients who need access can get access to these products?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: I think it’s always important to start with, you know, why has CAR T not taken off like you see? For example, I spent a big part of my career in checkpoint inhibitors, the PD-1 space. You would launch a new indication with the PD-1s. In about six to nine months, you were at peak market class share, and you were anywhere between 60% and 70%, depending on the actual indication. It was pretty quick. There were obviously factors in play there that are not in play for CAR T because if you look at the efficacy and the transformational impact for patients, not too different than what you see with checkpoint inhibitors. You’re giving people curative intent and the probably benefit of a CAR T, it’s a one-time infusion.

You take somebody from being reminded that they are a patient with every dose, every swallow of a pill, every tox, every side effect, to being a person again, after, you know, experiencing CAR T. From that standpoint, what you really start unpacking is what are those limitations? Those limitations, initially, everybody thought it was the manufacturers couldn’t scale. Candidly, that was true, including Bristol Myers Squibb. Once the manufacturers were able to figure out how to move and automate certain components, as well as scale operationally, now we are unlimited in our ability to supply the marketplaces, including into moving up into earlier lines. You really started unveiling what were the real dynamics in play here that were limiting a CAR T. It’s pretty simple when you really take a step back and look at it.

One is the CAR Ts are not delivered in every community practice, and so most patients, 70% of them, are treated in community practices around the United States. That dynamic is consistent in Germany. It also exists in Japan. Probably the one unique market is France, where CAR T class is its highest in the world. It’s at 40% CAR T class in France, and that’s because it’s an ecosystem that basically operates as one between community and academic center. Therefore, patients come into the fold. It’s determined what is the best mode and modality of treatment, and then they go get that treatment. In the United States, most of the patients are initially diagnosed with their community medical oncologists. It’s at that time, will the community medical oncologist refer that patient to a CAR T center or potentially reach to another modality that’s available to them?

This is where TCs have certainly put pressure on CAR Ts. I think when you talk to every single physician, and I mean almost every single physician, to a physician, they will say, CAR T is curative intent. A TC is not. I always challenge physicians in the community with, if this was your loved one, what would you want? To a person, they want them on a CAR T. The reason is because they recognize what the intent of the treatment is. It really goes into their mind of, but I have to think about the patients. Will they have the right treatment team around them? Will they be able to be at the treatment center for that length of time? Will they be able to have the right support?

One of the big green shoots that recently happened for us was the reduction of REMS and the reduction of some of the patient burden in the label. As one physician told me, four weeks at a treatment center, an academic center is like a sentence, you know, versus two weeks is a vacation. I won’t say who said that, and I won’t determine whether that’s true on either end. Maybe it depends on the academic center. The bottom line is, the point is two weeks is more rational for a patient and their caregiver to be away from family and other commitments to go receive a CAR T. I do think we expect some momentum coming from that decision.

I also think the other dynamic is, even if and when that momentum starts really building and you start seeing referrals increasing, community physicians start seeing that they can get their patient back in two weeks, there will still be physicians and patients who want to stay physically treated in the community, which is why we have a huge push right now on bringing CAR T to the community, literally infused in the community at a community center. We have two community centers today who deliver CAR T in the community. That’s Virginia Oncology and Tennessee Oncology, both successfully delivering CAR T. As a matter of fact, Virginia Oncology has treated over 90 patients. Dr. Simmons has been publishing on this, and he’s successfully and safely delivered CAR T.

I do think that’s the other big green shoot is being able to bring CAR T to the mega community centers so that CAR T can be delivered closer to home.

Courtney Breen, Large Cap Analyst, Bernstein: Absolutely. And kind of perhaps zooming in even more near term to kind of delivering on some of this potential, we’ve seen Bristol Myers Squibb perform pretty strongly over the last couple of quarters in the CAR T space. Is this down to the manufacturing unlocks, the out-of-spec scenarios becoming more manageable? You’ve obviously had some new indications come in. We’ve had the REMS label updates. What are the most important factors that have enabled you to start competing in a way where if you contrast this with some of your other CAR T competition that are going directly up against Breyanzi, where things slow down there? What’s different about what’s supporting this particular performance for Bristol Myers Squibb near term?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: Yeah, it’s important to remind people kind of the journey Breyanzi has been on. So Breyanzi, when we initially launched, we were three years to market after the initial two CAR Ts launched into market, and we were constrained for our first three years. That is not an ideal launch, but three months after being constrained and after working through a widening of our spec, it only took us three months to become the number one CD19 CAR T in the U.S. We are now number one in Germany, Japan, and France. It is that best-in-class profile that has really seen the surge. When we talk about our current robust, strong performance on Breyanzi, that’s really the profile working very hard for us. It’s also the fact we have the broadest set of indications for B-cell malignancies. We expect also we have the DUFA date this December for MZL.

It’s that profile from efficacy, safety, and manufacturing that has afforded us the opportunity. I think now, as I articulated, we do hope to see, based on moving into the community, and seeing some of that community growth. We also see much of Breyanzi’s growth is in the outpatient. Again, back to a differentiation of Breyanzi. Breyanzi’s safety profile allows people to move Breyanzi into the outpatient where those patients can be literally infused, sent home, and monitored, you know, they’re close to the center for a couple of weeks. That is unique to its profile. What we are seeing now is most, even academic centers are putting Breyanzi into the outpatient, which frees up capacity for them in their inpatient unit for CAR Ts that they have to deliver in the inpatient.

For us, we think both profile and the REMS would afford it the opportunity to continue to grow. What I will say is CAR Ts do have seasonality dynamics in the summer months. We do anticipate seeing some seasonality, but, you know, we’re really excited to see the second half grow for Breyanzi. As far as the REMS, everyone always asks me, how much do you think that class is going to grow? Honestly, it’s interesting. Only 2 out of 10 patients today who are eligible for CAR T are receiving CAR T, and that should not be, back to my point, if I were a patient and I think about being in the U.S., where healthcare and access to innovative care should be, you know, equal at minimum to France. The question really is, how do we get it to higher levels? That’s what we’re working hard to do.

It will take time. Just the fact that the label updated, each center has their own SOPs. Each center will determine, am I going to implement this update immediately, or take time? We’ve done market research with all of the major centers that deliver CAR T today. I think it’s mixed. Some are immediately implementing the two weeks, you know, staying at the center and two weeks back into the community. Others are doing it patient-dependent. A high-risk patient versus some are doing it CAR T specific, so they’re picking certain CAR Ts they feel that they could administer outpatient. Of course, we’re on the good end of that decision. Some are still doing a wait and see, like I want to wait and see. I don’t think that while the REMS is a green shoot, we’re going to see this immediate pop for the CAR T class.

I think this will be something that takes time.

Courtney Breen, Large Cap Analyst, Bernstein: That slowly evolves. As you think about that eventual split of what might be achievable outpatient versus inpatient, what could the future look like in terms of how many patients are managed in a more outpatient way?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: I think it’s really hard to put a number on it. I know everyone wants us to, and I understand. I think for us, it’s very difficult to quantify that. What we, how we think about internally is make sure we’re in the position to be able to supply, in that place. We feel very, very confident in that. Obviously, our goal is to make sure that the unlock for CAR T happens for patients. To every patient I speak to that gets a CAR T, they say the only thing I regret was I didn’t get it earlier, that I went on to get other modalities, where I was continually getting either infused or taking an oral, and I had no idea I had an option like a CAR T. For us, we will continue to work to get patients that ideal modality.

Courtney Breen, Large Cap Analyst, Bernstein: Absolutely. That makes a lot of sense. Maybe pivoting to innovation, I think there’s quite a few fronts here. As we look at your current latest stage pipeline, and you referenced a couple up front, there is real innovation in the targeting capability of the CAR T. You’ve got your GPRC5D, you’ve got your dual targeting options, which are pushing the boundaries in terms of how we can apply CAR T to some of these patients. There are also other innovations going on, the idea of in vivo expansion, the idea of off-the-shelf CAR T options. As you think about long-term innovation in this space, what parameters are really important in innovation as you look at the portfolio that Bristol Myers Squibb has or the portfolio that you would like Bristol Myers Squibb to have over the long run?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: I think it’s a really, really great question. When we originally kind of got into the cell therapy business, when we, through the acquisition of Celgene, which acquired Juno and obviously the partnership with Bluebird Bio, at that time, the world was an autologous world. There was a fervor pitch growing on allogeneics. We took a very methodical approach of really understanding, could an allo hit the efficacy bar that an auto CAR T could? The first gens really struggled. I think you guys have seen many of those companies kind of hit a certain fate as a result of not hitting those kinds of efficacy bars. We have also recognized an autologous CAR T will have a ceiling.

If you believe in the power of cell therapy, then we need to be making and have been making investments to unpack off-the-shelf solutions as well as continuing to accelerate auto CAR Ts. In a world, you know, 10, 20 years from now, where you might have coexisting auto versus, you know, allos versus in vivos, or a world where you start seeing some of these off-the-shelf, you know, take over auto CAR T, you want to be in a position to be able to make multiple bets. For us, we’re excited that we are, we’ve been patient and we’ve waited till we had the right construct and tested that construct in multiple different ways. We have our first allo that we’ve taken into clinic. We have our first person, first visit for an allo. It’s an allo for CD19 specifically designed for autoimmune.

We do think the highest proof of concept is in autoimmune. We say that because if you look at why the allo CAR Ts have struggled in oncology, it’s because they can’t get that same level of persistence that’s needed for the durable tail that you see a need in oncology. That might not be needed in autoimmune. After all, what they’re seeing to get this deep B-cell aplasia through the periphery and through the tissue, it does not necessarily need the persistence. It needs the depth. We feel pretty confident with our allo construct that it might actually be something that can achieve that. Obviously, we’ll prove that out in experiments and see if that scientifically works out. We’re quite excited to see that approach. We’ve also been making investments in vivo. I think in vivo is an interesting platform. Obviously, it’s much, much earlier and further out.

I think that is another great concept of can you potentially, you know, give a patient almost like a vaccine shot, and provide them that same kind of CAR expression. Early data looks super intriguing and interesting. We’ve been watching that field quite closely.

Courtney Breen, Large Cap Analyst, Bernstein: Fantastic. I think there’s lots of kind of add-ons that you can think of in the in vivo space of how do we get that immune system response to be as robust as possible and as reactive as possible as well. Maybe zooming in on those kind of key pipeline opportunities, I think Orva-cel is kind of the nearest on the horizon, the one that people are spending a lot of time in, a lot of time on. Multiple myeloma is a pretty mature market when it comes to innovation, when it comes to the cell therapy opportunities, but also when it comes to kind of the bispecifics. You’ve got some players there being very dominant across different modalities. How do you think about kind of your construct, why it’s exciting, and how you anticipate that entry in the market to look given the environment that you’ll be entering in?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: Yeah, so when you look at the multiple myeloma market, you still see a market where we haven’t yet found a cure, where we still have patients that are progressing. You now have a market where we have patients that are quad class exposed and really have nowhere to go. When we think about the role of GPRC5D, we see a growing marketplace of opportunity because more and more patients, as BCMA TCs and CAR Ts move up into earlier lines, you’re having more of those patients that are quad exposed and needing a place to transition to after. What we’re excited about, Orva-cel, it gives you optionality. When we talk to a lot of physicians, and initially when we saw our data, we were really excited about its efficacy.

I think what the two big ahas for the field were, one was it actually, the efficacy looked great in BCMA naive as well as BCMA exposed. That was very intriguing for physicians. They were pushing us to look at BCMA naive. The second was really its safety profile. I think a lot of people understood that, you know, 5D was a relevant target in multiple myeloma. The challenge was ongoing pressure on that target really has very high unwanted tox profile. From our standpoint, based on what they’ve seen with the TC that was in the market. When they were able to see putting pressure on that antigen one time, actually gives you the efficacy benefit, but without as many of the liabilities of the, you know, on target, off tumor toxicity. From that standpoint, we really are excited about Orva-cel.

As you know, we have two registrational studies ongoing right now. The first one, obviously, that we expect for data for next year is our relapse refractory multiple myeloma for that quad exposed population. We’re super excited about that based on what we saw in our phase one. We hope to see that data play out in our pivotal. Of course, we’ve also begun our earlier quintessential two trial, that actually is in the second line to fourth line patient population. We’re quite excited about the promise of that asset and what it can bring in the marketplace.

Courtney Breen, Large Cap Analyst, Bernstein: It certainly sounds because you’re going after a different target, your kind of flexibility around sequencing is much more likely to kind of give you potential for utilization in a number of different places for a number of different patients. Is that how you see it?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: 100% how I think about it. The one thing you can talk about with multiple myeloma, there’s lots of assets, but there’s lots of strategies. In other words, it’s very heterogeneous, not only in the patients, but also in how physicians treat. I think having assets that give you utility across multiple different approaches is very flexible for physicians and flexible for patients. I think that’s what GPRC5D offers.

Courtney Breen, Large Cap Analyst, Bernstein: Absolutely. I think the more we see that physicians have tools at their disposal, the more art kind of that comes into the way that they deploy their science. As we look at that pivotal readout in 2026, what should we be expecting to see? How should we be thinking about that particular readout? We’re seeing a lot of changes in the FDA, HHS, et cetera. I know that this is a line that all the companies are having to navigate and walk. Can you just talk about any interactions that you’re having with the bureaucracy and with the policy side of the equation as to whether this will look different or similar to what we’ve seen be applied to cell therapy?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: Yeah, so far, the FDA has not, we’ve had no experiences that would make us feel as though that either advice they had been giving us on an ongoing basis has changed. One of the greatest signals I’ve said to people that they have to remember, the label updates with the REMS was started with, you know, Peter Marks, then handed over to Nicole Verdun, but ultimately brought over the loan by, you know, for Brene Persaud. I honestly have not, we have not seen any changes in the FDA’s temperament. Obviously, there’s been reasons that people have concerns and questions, et cetera. When it comes to GPRC5D, this is an asset, boy, these primary endpoints are not tied to MRD. I think that’s everybody’s question mark.

Courtney Breen, Large Cap Analyst, Bernstein: Exactly.

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: This endpoint is not tied to that. We do expect no issues from that standpoint, and we hope that we can replicate what we saw in phase one, which was a very promising efficacy and safety profile. That’s what we hope to bring to the market.

Courtney Breen, Large Cap Analyst, Bernstein: Fantastic. Fantastic. I think we’ll be looking at that one very, very closely. The other thing that I wanted to ask is that you’re now looking at this dual-targeting. This is the next kind of cab off the rank as we think about after Orva-cel. What do you hope to achieve there, particularly in the context of the sequencing conversation we just had and kind of the use of BCMA kind of targeting agents across the board in multiple myeloma? How do you think about kind of this opportunity? We’ve also seen kind of bispecifics on the MAB side of the equation cause different types of outcomes or different types of tox for patients as well as we look at more dual-targeting in the cell therapy space. Is there anything we need to watch out for there?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: I think what people have to remember, there’s still an enormously high unmet need in this newly diagnosed multiple myeloma patient population. As we think about the dual CAR, we are looking to try to bring an asset with curative intent up into that newly diagnosed patient population, where the unmet need is still really high. There are still a lot of physicians who say in their mind, some of the CAR Ts have proven to show really great efficacy. They come with some liabilities and concerns, and those liabilities make them wonder, should I be exposing a patient into an earlier line, like a newly diagnosed patient, or should I be waiting because of the risk-benefit equation?

What our hope is here is that we can balance both great efficacy and deep durable responses along with a safety profile that would allow it to address that still remaining high unmet medical need in newly diagnosed multiple myeloma. We are obviously excited about this asset. We are moving forward at a very high pace in our dose finding trial. We’re looking forward to hopefully being able to release data on that and really hopefully see what kind of asset we have. The reason we’re excited about it as well is two things. One, if you remember, and it was an ask or a go, which seems like an eternity, when you started seeing bispecifics hitting GPRC5D as well as BCMA, you were seeing tremendous efficacy. What you were seeing was a lot of safety liabilities, which I think is what you were alluding to.

We do believe back to what we’ve seen with GPRC5D, when you put pressure on targets one time, and especially in a bispecific design CAR, you are also getting the nature of avidity. You’re not only putting pressure once, you’re getting avidity, which we do believe will buy down some of the side effect liabilities. Obviously, data will have to prove that out. That’s why we’re doing the scientific experiment. We do have a lot of enthusiasm for what this can bring. I can tell you for the physicians who are involved in this trial, there’s a lot of excitement building for this approach.

Courtney Breen, Large Cap Analyst, Bernstein: Fantastic. I did see that you had the IBRA data that came out this morning, also in the multiple myeloma space. We won’t dive into that deeply here, but it seems like Bristol Myers Squibb is going to be in that position to be able to play across a number of different assets as well, which is obviously valuable.

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: It’s super important for multiple myeloma leadership as a company.

Courtney Breen, Large Cap Analyst, Bernstein: Absolutely. I did want to make sure that we had a good chance to spend some time on immunology. This is because as I think about CAR T and I think the way that you’ve set this up as well, this is the next frontier as we think about where this innovation and technology can be deployed. Maybe just starting at the highest level, a very simple question. What kind of patients are potentially relevant for CAR T when we think about immunology? Is it the sickest of the sick that have been experiencing very refractory autoimmune diseases, or is there a path to this being a broader patient population?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: Yep. Right now, obviously, our trials are designed for kind of that refractory severe population. I think there’s two things to remember. One, that’s naturally where we should start, obviously, to kind of understand the risk-benefit of the modality in this patient population. What I have to always remind people, including internally, is that hematology, when you compare the population that CAR T is in today versus the severe refractory population in autoimmune, you’re talking anywhere between three to five times this patient population size. The reason is autoimmune disorders are much bigger populations than what we see in hematology. Already you see a very sizable marketplace.

What we also have been seeing based on the data that’s been already out there in the marketplace, including our own, in auto CAR Ts, is a lot of physicians are saying, listen, a lot of the severity has been organ involvement, organ damage. Some of it’s not reversible, and this is why people have seen some of this proteinuria that exists in SLE, for example. The reason for that is you can’t reverse organ damage. There are a lot of physicians who are pushing us to try to move these things into more of these mild, not mild, but to moderate patient severity. Obviously, that will determine based on when these profiles completely read out, because of course you want to be able to say, can you replicate what you did in kind of the early work in your later work?

If that does happen, and you start seeing a risk-benefit profile be such, of course you’re going to see both patients and physicians want to move these into earlier lines, or in this case, into patients without as much severity or organ involvement.

Courtney Breen, Large Cap Analyst, Bernstein: Fantastic. Just kind of understanding that scale of even the refractory patients is quite impactful when we think about this long-term opportunity, as you say.

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: I can’t help but go back for a second for the patients, because I think about some of our patients that we’ve already treated with our CD19 CAR T that we’ve published on or had an ACR. These are patients in their 30s. These diseases are robbing them of their life. To think about what a CAR T has now provided these patients who are now treatment-free and disease-free. These were patients that were told about their diagnosis, and they were told that they were going to be put on immune modulators for the rest of their life. Some of them with such high doses of steroids that they would not be able to rear children. To be able to think that they could potentially get a CAR T and have one of these responses and have a new lease on life.

For us, the excitement is really palpable and what’s potentially here for patients.

Courtney Breen, Large Cap Analyst, Bernstein: Absolutely. Absolutely. I think this investment in the CAR T space and immunology has been part of a perhaps broader rethink at Bristol Myers Squibb around immunology. We saw your spin-off more recently. I think you spoke in that announcement in terms of really focusing on assets that have the potential to reset the immune system and promote tissue repair, and that ability to invest in areas where Bristol Myers Squibb is best positioned to lead. As you think about this, similar to how we just mentioned on the multiple myeloma space, there are multiple assets that sit around the CAR T space. Do you think about the ideal portfolio in the immunology space? What role does CAR T have in that strategy?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: When it comes to the immune reset, I think it’s really the cornerstone, right? The efficacy bar has been established by auto CAR Ts. What everyone’s now doing, including ourselves with moving our allo CD19 into clinic, is trying to determine, can you reach that same efficacy bar with a more off-the-shelf solution so you can bring it into the community rheumatologist offices? When we think about kind of where CAR T sits, we think it has set the bar. The question is, can we replicate that with other shots on goal? That’s what we’re continuing to explore as a company.

Courtney Breen, Large Cap Analyst, Bernstein: That’s super exciting. Maybe just diving into the CD19 Next T, tell me about that asset and why this asset feels like the right one for you to really pursue at this point in time with what we know about CAR T in the immunology space.

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: The first thing that people need to know about our CD19 Next T, it’s Breyanzi’s construct that we put onto a shorter manufacturing process onto a single train. We have years and years of understanding translationally, clinically, and manufacturing from Breyanzi that has fueled our excitement on what this construct can bring from an efficacy and safety standpoint. That understanding builds really great excitement. We’ve now seen this product perform in multiple different disease areas from SLE to MS to scleroderma, myositis, et cetera. We’re really excited about what it’s performing and what we hoped it would do as far as getting deep B-cell aplasia both in periphery and the tissue and making sure that we truly induce this immune reset. What we’re seeing is these patients indeed are coming off their immune modulators and are disease-free.

This, for us, is why we’re really excited about this asset and its potential. It’s why we also were really aggressive in our CDP, so our clinical development plan. We have Break Free 1, Break Free 2, as well as our Break Free SLE, all kind of in parallel. Typically, in autoimmune, you kind of test an asset in a disease, you wait to see what it does, and you kind of move into other diseases. We have been so bold based on what we saw early that we wanted to go out into these basket trial designs to go after multiple populations at one time to be able to accelerate kind of our position across multiple indications, I should say.

Courtney Breen, Large Cap Analyst, Bernstein: Absolutely. I think there’s so many pressures on pharma companies and on pharma innovation that it’s becoming more and more important to take on risks like that because you’ve got competition coming or because you’ve got maybe not in the CAR T space in the same way, but you’ve got the Inflation Reduction Act kicking off your timer. You’ve got the need to run those parallel trials in a way that perhaps in the past would have been sequential. Balancing that risk-reward becomes really complex and really important. As we think about this innovation, we’ve talked a bit about the science on the immunology side and why this is exciting. We began this conversation though with why has this been hard for us to achieve real impact on a broad basis in hematology.

As we look forward in the immunology space, what needs to happen and what are you doing today and what do you anticipate doing over the next three to five years as you’re advancing this asset in the clinic to make sure that your rheumatologists, your other immune doctors, inflammation and immune doctors around the world are in a position to deploy these products for the right patients at the right time?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: Yep. We asked a very question when we decided to put that asset into clinic was what would have to be true for this to be a meaningful market. It’s why right upon putting it into clinic, we developed something called the Action Network. It is a body of physicians who are advising at the top, rheumatologists, along with hematologists and neurologists, informing not just how to clinically unpack a CD19 CAR T, but also how do we actually create an ecosystem that allows for rheumatologists and hematologists to work more in partnership to both identify who’s eligible for these CAR Ts, but to ensure that these patients get access to CAR Ts. We recognize if it was a struggle in lymphoma for only two in ten, it will be a bigger challenge in rheumatology.

We have started the work now, not upon approvals, to create an ecosystem that allows for CAR T to be more broadly used.

Courtney Breen, Large Cap Analyst, Bernstein: Fantastic. Can you contrast for me kind of the U.S. versus the ex-U.S. space here? I think healthcare systems look really different around the world. The treating physicians often look different. Even the kind of degree of innovation that’s made it from the U.S. to the ex-U.S., particularly in the immunology space, can be quite drastically different. How do you see this becoming either a global product or more of a U.S. kind of opportunity in the first years?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: We are certainly designing this to be a global product. My first measuring stick on whether or not there is global interest is how well the trial is recruiting. I can tell you globally, the trial is recruiting really well, so there is a high desire, you know, in markets to be able to bring this type of innovation to patients. For us, that’s why we are working not just in the United States to create this ecosystem. Many of the people on our Action Network are not just United States based, but they’re also European based, et cetera. We are looking to try to help support an ecosystem more broadly. The dynamics you’re talking about are real. There are some markets where those dynamics are harder, where the receptivity to innovation and the price of innovation is not there. Obviously, that makes it a bit more challenging.

Certainly, I think when it comes to the desire to deliver that kind of innovation to patients, that exists in every country we’ve been bringing CAR T into.

Courtney Breen, Large Cap Analyst, Bernstein: Absolutely. Maybe in our last kind of few minutes, I would love to just get your thoughts on if you’re sitting here in this role in kind of five, ten years in the future, what does cell therapy look like at Bristol Myers Squibb by then? What will you feel kind of needs to be true for Bristol Myers Squibb to have said that we’ve succeeded in delivering against the opportunities in the cell therapy space?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: No, it’s a great question. It’s when we have our vision statement around unlocking the full potential of CAR T, it is grounded in us delivering this transformation modality to over 100,000 patients. I do know that when we first made that ambition four years ago, it didn’t feel fully plausible, but wanted to have people starting rallying behind something that seemed maybe a bit impossible, but to then see them along the way making it possible. We’re getting there through strides of innovative science that’s moving into other disease areas. We’re getting there through moving to automation for our autologous. We’re going to get there also by moving to off-the-shelf designs and solutions. For us, success looks like that not only have we achieved the 100,000 patients, that we see patients in diseases where functional cure wasn’t dreamt possible, is possible.

That to us will be something that I hope in five years I can sit in front of you at this panel and say that we’ve done.

Courtney Breen, Large Cap Analyst, Bernstein: That is fantastic. My final question, because I think this is always a fun one, is what are the questions that you get that you think kind of you want to clarify? Is there something where you say people really misunderstand this thing about kind of cell therapy and about our opportunity going forward?

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: I do think it starts with when people kind of say, you know, why CAR T? I remind them to put them in the shoes of a patient and say to themselves, would you like, door number one is a one in two chance. This is, I’m talking about diffuse large B-cell lymphoma. If you have diffuse large B-cell lymphoma, you’re progressing off R-CHOP within 12 months. Do you want door number one, which is a one-time infusion that you have a one in two chance for a cure? Do you want door number two, where I’m not going to give curative intent, but I’m going to be able to treat you and you might have a long PFS, but you’re going to be coming in for ongoing doses, et cetera? I just don’t know a person on the planet who chooses door number two.

For me, it’s that constant reminder of why door number one. It comes with additional complexities and other considerations. For me, that’s what we should be good about in the healthcare system is how do you remove those complexities so that more patients can choose door number one?

Courtney Breen, Large Cap Analyst, Bernstein: That’s fantastic. One thing that you said earlier on that I do want to finish on, you spoke about the fact that kind of a two-week vacation is very, very different.

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: That was a physician who said that.

Courtney Breen, Large Cap Analyst, Bernstein: As a longer-term resident, I’ve just spent five weeks living out of a suitcase. I can tell you, two weeks living out of a suitcase is so much nicer than five weeks living out of a suitcase.

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: Yes, fair enough.

Courtney Breen, Large Cap Analyst, Bernstein: I do resonate with that perspective. Thank you so much for your time, Courtney.

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: Thank you, Courtney.

Courtney Breen, Large Cap Analyst, Bernstein: This has been wonderful. I feel like we’ve managed to dive into a whole lot of detail around kind of where Bristol Myers Squibb is going in the future and what unlocks are required in the cell therapy space. We’re really excited to see this innovation come to patients and have real impact. Thank you so much.

Lynelle, Head of the Cell Therapy business, Bristol Myers Squibb: Perfect. Thank you so much, Courtney. Appreciate it.

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