BMYMP - Bristol-Myers Squibb Company (BMY) Presents at Goldman Sachs 44th Annual Global Healthcare Conference (Transcript)
2023-06-13 14:55:23 ET
Bristol-Myers Squibb Company (BMY)
Goldman Sachs 44th Annual Global Healthcare Conference
June 13, 2023 11:40 AM ET
Company Participants
Lynelle Hoch - SVP, Global Cell Therapy Franchise
Roland Chen - SVP, Cardiovascular Development
Conference Call Participants
Chris Shibutani - Goldman Sachs
Presentation
Chris Shibutani
Okay. Let's get under way. Good morning, everybody. Welcome to the second day of the 44th Annual Goldman Sachs Healthcare Conference. We are very pleased to have Bristol-Myers join us. Today from the team, an opportunity to really focus in on some of the key business segments, we have Lynelle Hoch, Senior Vice President, Global Cell Therapy Franchise, live and in person. You were impressive on Zoom at ASCO
Lynelle Hoch
Yes.
Chris Shibutani
And Roland Chen, who's an SVP in the Cardiovascular Development, also a very strategic pillar in terms of the portfolio for Bristol.
So, what I like to do is make these conversations, some connectivity that you're not just mouth pieces for Tim and Nina, but we know a little bit about who you are, where you came from. So a quick snapshot on your professional journey that brings to bear, so that we know how you think about stuff, communicate what's been in your dark and mysterious past. Lynelle, you first.
Lynelle Hoch
Okay. My dark, mysterious past. So, Lynelle Hoch, I've been at BMS for 27 years. I came through a less infamous acquisition known as DuPont. I spent five years at DuPont. I'm an engineer by training, so started at DuPont Chemical before I moved over into the pharma business. I thought it was far more exciting than my engineering days. And so -- and I've navigated my career at BMS across multiple different therapeutic areas, probably most known, as leading the U.S. IO business during its series of launches across both Yervoy and Opdivo. And then, I was leading the UK and Ireland business before I got asked to come back and lead our Cell Therapy franchise, which in BMS’s model means I'm accountable end to end from the research through the manufacturing to commercialization.
Chris Shibutani
Terrific. Roland?
Roland Chen
Yes. No, thanks, Chris. It's great to be here. So, I head Cardiovascular Development at Bristol-Myers Squibb, where I've been there for about 23 years. I am trained as a physician, but also as an engineer. You learn new things about colleagues every day. You have to sit up on stage, to learn them. Prior to my role as Head of Cardiovascular Development, I headed Clinical Development for really what would be considered our non-oncology portfolio, previously. Before that I had the chance to head our Pharmacovigilance and epidemiology group. And so, again, it's a pleasure to be here, Chris. Thank you so much.
Question-and-Answer Session
Q - Chris Shibutani
Okay, terrific. I think the logical way to think about this is maybe to talk about the Cell Therapy business first and then go on to the cardiovascular side. I'll try and keep an eye on the clock so that we're fair. But then I also, beyond talking about sort of the key issues that all of us care about, I will thread in a little bit of a discussion about your view on the implications potentially of the IRA on development strategies, et cetera. So, fresh off of ASCO, EHA is also in the air, a lot of excitement over CARTITUDE-4. Talk to us about what you see as sort of like the most important takeaways from those data presentations.
Lynelle Hoch
Yes. So, we went into ASCO, very confident as Bristol-Myers Squibb and came out more confident. Why do I say that? For one, we got to see the Multiple Myeloma Consortium real world data that essentially from last year to this year replicated Abecma’s efficacy, safety and manufacturing reliability that we saw in KarMMa. I mean, obviously, extremely meaningful, as you can imagine, physicians, they want to make sure in what they see and get from an asset that it delivers for their patients in the real world, and that's certainly what they got to see in the real world data, despite the fact that 75% of those patients would not have qualified for KarMMa based on their comorbidities. So, we were quite excited to see that. And again, the manufacturing reliability at 94% is extremely meaningful in this field.
In addition, when we think about KarMMa-3, we think about a triple-class exposed patient population, 100% of our patients were triple-class exposed. 95% of those being dara-refractory. So, understanding the context of that data in the context of the competitive set, we walked off the meeting feeling very confident: one, based on KarMMa-3 performance; but also two, in our statistical methodology congruent with the FDA, we feel we're in a very good position in the multiple myeloma marketplace coming off that meeting.
The final thing I'll say is, of course, we had other data there on CLL for Breyanzi, but I can hold that because if you might have a question for me on that field. But yes, in multi-myeloma, we felt very confident on that data.
The final thing I'll say, what is clear to us, both on CARTITUDE-4 data and with KarMMa-3 as well as TC engagers is you're going to see BCMA targeted assets move earlier and earlier lines, which means you're going to have a large post-BCMA marketplace, and we were quite excited. I am of fresh off Frankfurt, Germany, maybe a little bit jet-lagged flying here from there. But I've seen data for our GPRC5D, which is now in over 60 patients. We're seeing consistent efficacy results and a side effect profile with that onetime dose. We're seeing really good safety profile, unlike the T cell engagers, where you're seeing ongoing continuous hit of that target, which can cause some problems from a on-target but off-tumor side effects. So we're quite excited overall in multiple myeloma, both on our competitive position commercially today as well as we think about well poised with our pipeline.
Chris Shibutani
Terrific. So, a veritable cornucopia of opportunity in cell therapies, let's see what spell check does on a transcript with that one. So, sticking to CARTITUDE-4. Are there subgroups that you think are most suited to Abecma based on the data?
Lynelle Hoch
So we hear from a lot of different TLs that they certainly look at these two assets and say to themselves, it's such a fragmented marketplace. And for them, they see enough space for both. And so what we often hear is sometimes patients greater than 70. Obviously, that's a large segment of multiple myeloma. When you think about that disease state is something they think about the overall profile of a drug like Abecma very advantageous for based on efficacy as well as its safety profile, which is extremely important consideration set when they dose these patients.
Chris Shibutani
And then when we think about what the -- sort of the requirements are from a regulatory standpoint, how do you think in these earlier line patient populations of the importance of overall survival data?
Lynelle Hoch
So, I think it is important, but more and more physicians are understanding, listen, how we design trials to be able to be patient-centric and get these asset data into the market quickly as well as to allow in design crossover is the best thing for patients, and I think more and more physicians look at other markers to determine their satisfaction and whether the efficacy will hold up. So, we feel very confident on our package as we think about our current and ongoing dialogues with health authorities.
Chris Shibutani
Let's talk about the ongoing commercialization of Abecma. It's been a few years. There have been challenges. We'll talk a little bit about the manufacturing, but maybe you can help us with sort of any sort of feedback from the field in terms of what's working, how is their success, what could improve. Again, it's sort of like really in the trenches with the commercialization aspect now.
Lynelle Hoch
Yes. So, obviously, with autologous cell therapy, I think every manufacturer has been on a journey of learning kind of dealing with heterogeneous patient populations coming in and having that variable patient material oftentimes much sicker than what you saw in your clinical trials. And so I think what we've been able to learn in over two years is that you're basically taking those learnings, being able to apply those and what you're seeing from physicians and what they're saying is -- and we've heard this quote from many very tough physicians that said, you've figured it out. I don't know that I would ever say we figured it out. But what I will say, when you see 94% manufacturing success rate, that is probably as good as you're going to see it in autologous cell therapy. And what physicians say back to us when we -- patients that we go ahead and [ph] commit to go on to cell therapy, and when they get that product back in a very fast turnaround time and with a high success rate that is extremely meaningful to them in their treatment sites.
So for us, from a commercialization, our folks can focus on differentiating the asset versus spending their time defending kind of our manufacturing operations, and that's a great place for the commercial organization to be in, and they're certainly excited to be in that space.
Chris Shibutani
Let's talk about manufacturing and supply. This is not a simple process and it’s one, again, with the word journey probably should be applied to. Talk to us about where we are and where you think the progress could be made as we head into the back end of this year and then naturally over the next couple of years? A couple of specific facilities that we should toss around, names like Devens and Libertyville and stuff. Just update us on where we are.
Lynelle Hoch
Yes. So, when we talk about manufacturing, we think about it in three buckets. First and foremost, we think about vector supply, so our ability to have enough vector to be able to meet the demands in the marketplace. And that has transparently been a challenge for BMS. We single source adherent lentiviral vector for both of our assets, which became a challenge and you've heard us report that at multiple earning calls and multiple investor dialogues.
Clearly, we've had some successes on adding additional suites, including one for Abecma just this year of adherent lentiviral vector, but most notably, was the addition of Libertyville. That facility will be our first move to dual sourcing. And as part of that dual sourcing strategy, we'll be internalizing vector. So, that obviously gives us a lot more opportunities to ensure that vector is not a constraint. In addition, Libertyville represents our ability to accelerate into next-generation technology, both suspension and hypersec, [ph] which, as you know, gives you greater yield of vectors. So, the vector becomes more of an afterthought than really the storyline, which it has been for us on manufacturing.
The second component we look at is drug product capacity. Our ability to deliver from a drug product capacity, it starts with your state-of-the-art facilities and your ability to ramp in partnership with health authorities, those facilities. And you just had said, we have just announced Devens, which is now our fourth state-of-the-art facility, our third commercial state-of-the-art facility. We have one in New Jersey in Summit. We also have a facility in Bothell, and now we have one in Devens, Massachusetts, and we will have one aiming for 2025, early '25 for Leiden, which will really help our European markets in that standpoint. So, we're feeling very good on our progress on GP capacity.
And then the final point is how successful you are at hitting dose, and when you hit dose, how successful are you having in spec product, which is important when you think about commercialization and generating revenues? And what we have seen is great success, as I've already articulated on Abecma, so, I won't underscore that again. But on Breyanzi, we’ve been on a bit more of a journey but we are starting to see some great progress there as well. So, I would say we are in a great position and growing in strength across all three of those dimensions.
Chris Shibutani
Help make us a little bit smarter and geeky about in spec. What are the kind of numbers that you're currently at and that we should -- ultimately thinking to ask them too, in terms of thinking it's like, yes, they've got this under control?
Lynelle Hoch
Well, I'll make this, not because you guys can't handle the complexity, but it could take you hours. For those of you know how many specs we actually have to hit, and it depends on asset. And it also depends with in an asset across the different lines of therapy because we have different spec release for each indication as well, which is not something to field like, and we're working with the FDA to try to harmonize specification releases. But typically, what you see is 97% of our products are in-spec clinically, which means we can administer it. So it gets to our patients. So that's the great news that patients today for both Abecma and Breyanzi, regardless of it's commercially in-spec, get our product because it's clinically in spec, which means it was in the same specifications your efficacy and safety was demonstrated in your clinical trials.
But for Breyanzi, it is commercially in spec, it is our spec through the BLA process, we're tight. That tightening has been very, very challenging for that asset. Abecma, we were more successful in our BLA process, and we have specs. As I said, we are at 94%. So, we have quite a high in-spec rate, as well as manufacturing rate on Abecma.
Chris Shibutani
Got it. Let's talk about GPRC5D. It's like the password that you would never want to know. Is there an in-house slang, shorthand for this one?
Lynelle Hoch
5D. We call it 5D.
Chris Shibutani
5D. Okay. It’s 5D, guys.
Lynelle Hoch
And you know it’s so funny, I said 5D to a customer and he looked to me, he's like, what? And I said, oh, sorry, that's in-house. It's too many letters for GPRC5D. But yes, 5D.
Chris Shibutani
Okay. Highlight us on 5D, the data that was recently presented?
Lynelle Hoch
We're quite excited about this asset. For one, as I articulated earlier, with a larger and growing post-BCMA marketplace, but it's important for me to point out, for those of you who have been following GPRC5D. We first revealed data at ASH. And then we've had more follow-on data as well as dose expansion data at EHA. So now over -- or I should say 67 patients have been exposed to GPRC5D. And what are we really excited about on this asset for, one, its efficacy profile has been quite impressive. So, if you've seen across the different doses, very high ORs and CRs. And what is also equally exciting, what people were wondering was what would a CAR-T 5D asset look like in a patient population, juxtaposed to the bispecific or the T cell engagers, I should say.
And what we're quite excited to see is, again, back to a combination of it's a onetime dose and getting that dose correct as well as looking at our manufacturing process, we're really seeing a very manageable side effect profile, which is quite exciting for the field, and we heard a lot of buzz from TLs. As a matter of fact, the line of people that would like to be doing these clinical trials with us is quite extensive because they're starting to see the impact of this asset.
Chris Shibutani
What's next? When is the next time that that will appear with an added data?
Lynelle Hoch
So we haven't disclosed that, but I can tell you we're working quite fast. As you can imagine, being first and best, which is what we think we have in this asset is critical. So, we'll be working quite fast with our -- with health authorities. And so, you guys will certainly -- as soon as we have data that we will release, you'll be sure to see it.
Chris Shibutani
Okay. We'll keep asking. On Breyanzi, let's talk commercial utilization, second versus third line. What's the rough split now? And what are the trends looking like?
Lynelle Hoch
Yes. So, the demand for CAR-Ts in large B-cell lymphoma remains extremely high. I think people really appreciate the curative intent of the CAR-Ts in particular two of them. And so what I would say is right now the fastest-growing segment of our business is second line. That best-in-class profile that people see with Breyanzi with a combination of very strong, deep and durable efficacy, along with the safety profile, that profile means more and more as you move into earlier lines because that safety profile, as you can imagine, is extremely important treatment consideration as physicians treat earlier line. So, definitely seeing a greater mix there. It's around 60-40 right now for second line versus third line, and we certainly see both lines growing, but that's the fastest-growing, second line.
Chris Shibutani
And then the clinical push to the outpatient setting, I think the last comment from the house was that 15% to 20% of patients are on an outpatient basis. Is that continuing to be the case? And where do you think that could be in a couple of years?
Lynelle Hoch
So, it continues to be around 15% to 20% of outpatient. I will say we just had a great win this week with CMS. So, CMS will now be adding Breyanzi as part of their ASPs. You know they quarterly report out ASPs, that will be starting July 1st. So Breyanzi will be a part of that mathematical equation, which as you can imagine, can be a barrier to a hurdle for the Medicare population to be treated in the outpatient when you don't have an ASP number. So that also, I think, will help any kind of resistant facilities might have been having on using outpatient. So I do think it will grow for sure.
I think the confidence people are gaining on Breyanzi and its overall profile means that you probably see more and more outpatient. But it's always important, I think this room knows is outpatient isn't like pure community oncology play. You still have to lymphodeplete these patients, you still have to bridge these patients and you still have to monitor these patients. And so, outpatient meaning they won't be hospitalized for as many days. And as you saw in real-world data, the hospitalization -- re-hospitalization data on Breyanzi is very strong.
Chris Shibutani
Indeed. Thinking about another intersection is, once again, the potential entry and the competitive threat in the choice is bispecifics. How are you thinking about that here in this indication?
Lynelle Hoch
We continue to hear from physicians whether it's at ad boards or market research or just in general interactions with customers, the CAR-T efficacy is really the bar. And when they're thinking about going for a curative intent, they think of CAR-Ts and CAR-Ts first. And they do think sequentially, starting with a CAR-T and going to a bispecific, it's still the right strategy. The counterpoint to that is that do I have a slot, right? So I think as we and the field continues to increase our capacity on CAR-Ts, which we have been doing, you're going to see more and more physicians continue to move toward the CAR-T first. And that for patients who cannot get access to a CAR-T for some reason, it's not a consideration set, then there's an obviously option with the bispecific.
Chris Shibutani
And the competitive dynamics with Gilead and Yescarta, there are so many factors that are kind of correction factors, whether it's supply, issues, et cetera, how do you see the ultimate share splitting out? We talked to a lot of KOLs, where it's just like there's an appetite for what's available and logical, but ultimately, is there some sort of framing of the competitive dynamic in the share that you can help us with?
Lynelle Hoch
So, yes, we don't kind of get into the whole kind of framing of the share. But what I can tell you is we're quite confident on Breyanzi and its potential into the future. And I say that for two reasons. One, of course, we feel strongly about its best-in-class profile in large B-cell lymphoma, but also based on kind of the data that we presented at ASCO and CLL, we are the first and only CAR-T to demonstrate those deep and durable response in CR, despite others trying in a pivotal study. So we're quite excited about our ability to go breadth-wise as well as recent releases of follicular and MCL, which will be shared at ICML this week.
And so, when you think about Breyanzi, we think now as the broadest array of B-cell malignancies that Breyanzi will be able to play in to drive our share and our volume as well as our best in profile in large B-cell lymphoma. So, we feel quite good about our position over time with Breyanzi.
Chris Shibutani
And as I promised at the beginning of our discussion to wrap up on the cell therapy, when I say IRA and cell therapy, investors should be thinking what?
Lynelle Hoch
I think it's still early and for all therapeutic areas, but particularly for cell therapy. As you know, most of cell therapy is administered in a hospital, so mostly Part A. So the impact of cell therapy in IRA is lower. But even inside of Part B, which we just talked about expanding into outpatient, I think it's still early days. And so you had kind of started your conversation with, does it have you thinking differently about research and development? And I would say, no. I think we will continue to push innovation and push cell therapies where we think we can have curative intent. And IRA is not changing kind of our pursuit of that aspiration.
Chris Shibutani
Terrific. Roland, let's move on to the cardiovascular side of the equation here with CAMZYOS, in particular.
Roland Chen
Sure.
Chris Shibutani
An innovative product and clearly, a commercialization challenge. You're basically changing the paradigm between like really two very inadequate difficult options from a treatment standpoint. So, there's a lot of hocking of the weeds here. An important label expansion opportunity is coming up with the VALOR trial results, where we have a PDUFA coming up this month here. When you talk to the folks in your team development-wise and thinking about commercialization with physicians, how impactful will the addition of this to label be?
Roland Chen
Yes. Thanks for the question, Chris. So when you think about VALOR, maybe stepping back. I mean, VALOR was a double-blind, placebo-controlled study of CAMZYOS versus placebo in patients with highly symptomatic obstructive HCM. These are patients who don't have a lot of treatment options, other than a highly invasive procedure that is SRT. And so, when you think about the results of VALOR, what we saw really are two things. We saw that it reaffirm the profile of CAMZYOS as evident in the EXPLORER study. That is with respect to both efficacy and safety. But I think more importantly, for the patients in the VALOR study and hopefully more broadly, what we saw were very clinically relevant and statistically significant, of course, differences in the numbers of patients who remained eligible or elected to undergo SRT.
Again, the clinical importance here is that these are highly invasive procedures as really a last stop option for these patients who have refractory HCM. CAMZYOS offers a potential other option there. And I think with that and to reaffirm again with additional data and it continues on in the longer term, the efficacy and safety profile of CAMZYOS a chance to meaningfully impact the unmet need of these patients experience. So we think really important impact because of the clinical relevance of these findings.
Chris Shibutani
Right. And you're threading over to something that's really foundational to thinking about what the peak sales opportunity, and that's the duration of benefit, long-term extension studies. You presented some data to date, talk about your view of the likelihood that CAMZYOS will be convincing and compelling in terms of being able to sustain and maintain the kind of benefit longer term?
Roland Chen
It's a really important question, Chris, because when you think about the amount of time that you have to study these compounds in the short term, it could be 30 weeks. It could be 16 weeks and so on. But we presented data, for example, at the previous ACC meeting. We presented data with CAMZYOS used up to 84 weeks. And what we see there is data, which reaffirms against sustained improvements in cardiac biomarkers. We see sustained improvements in NYHA class improvement and in left ventricular outflow tract gradient with a safety profile that continues to not show anything new which gives us confidence in the longer term.
I'll also say that we presented earlier this year at ACC some interesting data based on CMR, which shows favorable cardiac remodeling effects. Again, something that's very interesting in terms of the promise and the potential of CAMZYOS in terms of things such as left ventricular hypertrophy as well as volumes that we see in the longer term. And then, finally, we presented this at AHA in 2021, some data even in the non-obstructive form of HCM where we saw, again, sustained improvements in cardiac biomarkers, NT-proBNP, other biomarkers. But I think also importantly, in echocardiographic parameters, which suggests that CAMZYOS have had favorable effects in this case at 48 weeks on parameters that are important, left ventricular performance, diastolic function, filling pressures. And so, a number of pieces of data that give us confidence in the longer-term profile of CAMZYOS moving forward, Chris.
Chris Shibutani
Great. And obviously, the indication is for the oHCM, obstructive hypertrophic cardiomyopathy, you made reference to the non-obstructive side of it, the ODYSSEY study. Talk to us about your level of confidence and the potential for that to read out. I think we have some cross industry similar mechanism of action data points, MAVERICK, et cetera. What does that mosaic we do to shift your thinking towards the nHCM opportunity and that data?
Roland Chen
We're very excited about the nHCM opportunity, Chris, as well as having kicked off the ODYSSEY Phase 3 pivotal study. I think when you think about nHCM, of course, fundamentally and in key ways different than oHCM, but obviously, phenotypes that share common characteristics. If you think about what CAMZYOS can do, provides some confidence in the nHCM space. But I think even more so, when you think about the data that's come out of MAVERICK, we touched on a little bit of it at the shorter term, when you think about the effects in biomarkers as well as some of the clinical parameters and subgroups.
Small study, I think that's why you have to do the larger Phase 3 study. But on the other hand, when you think about the longer-term data that I just mentioned, it gives us confidence. It's also given us confidence about how we might think about dosing a cardiac myosin inhibitor and nHCM. You get insights when you are able to follow patients for a longer period of time. And so when we think about nHCM, it's still a condition with high degrees of unmet need. There aren't a lot of options for these patients.
And it's a progressive disease. In certain cases, patients have to go on for transplant. There can be malignant arrhythmias. And so, we're very excited about bringing forward CAMZYOS in the ODYSSEY study. We've just kicked that off this year. It's proceeding as we anticipated. And so, we're looking to continue to do everything to continue to track to 2025.
Chris Shibutani
I've always personally been very fascinated by this therapeutic and this patient class, et cetera. I was practicing critical care medicine in the 1990s at Mass General. And thinking about all the geeky hemodynamic parameters and echocardiograms and this crosscurrents, creating all these data points, and sort of adoption and utilization, is there something singular that you think is really valuable in terms of getting the liftoff on this product and the adoption and the understanding, because I feel like it started as a scientific concept. It's going through its adolescents as a business. And when does it become kind of like a real franchise and a way to go to on this thing. It doesn't have the beauty and simplicity of LDL-cholesterol, get it to 100 that was basically designed on Madison Avenue. This is more complicated. But what's at the essence?
Roland Chen
Yes. That's a fascinating question, Chris. I think when you think about -- it sort of follows the way I see it is the data evolution that you've seen in this class. And so, you see parameters, shorter studies, smaller numbers of patients, and you follow biomarkers, you follow echocardiographic parameters. You're not completely sure [Technical Difficulty] consistencies. You look for consistency across parameters. And then I think what happens is with EXPLORER, with VALOR, with CAMZYOS, you see changes in meaningful outcomes, that is patient outcomes. So we're talking about feel and function. Things in patients where, again, there aren't options or the ability to avert really, really invasive procedures. And I think that's really the start. If I understood the question properly, that's the start of showing where the inherent and real benefits to patients for these drugs are. And so, yes, you continue to follow these geeky biomarkers and echo parameters and all of that, which are critical as you think about it in the long term, and you help use that to build your story then in the longer term. Because again, you have to continue to sort of build that foundation. But I think having shown outcomes is that start. And I think that's where it all starts and really ends, I think, if we can provide benefits to patients who don't have a lot of options.
Chris Shibutani
And then finally, for CAMZYOS, the next frontier is looking at HFpEF, the EMBARK study, proof of concept and talk about taking this further down the line ultimately to Phase 3?
Roland Chen
Yes. Thanks. We're very excited about the opportunities of cardiac myosin inhibition in heart failure with preserved ejection fraction, it's an area. It's hard to develop it. It's a heterogeneous condition, maybe some phenotypic commonalities. But again, I think an area where there's a great deal of unmet need, in spite of recent advances. So with the EMBARK study, we gain enthusiasm and confidence based on what we saw in MAVERICK, and we're building on that foundation because there's a lot of commonalities in patients who have HFpEF with those who have the non-obstructive form of HCM.
What we're looking for really simply is can you dose with cardiac myosin inhibitor in a safe way, primarily in a smaller Phase 2a study, but also see hints of efficacy as well. And that's what we're really looking for here. Can you dose it safely and make sure that patients can tolerate cardiac myosin inhibition in those who have HFpEF. And then you look for, again, as we talked about, signs of improvements in biomarkers. Are we reducing NT-proBNP, look at echocardiographic parameters? Are we seeing improvements and filling pressures or volumes? And then, I think most importantly, in a study of this size, you look for consistency across these various parameters, because you don't have the duration or the numbers of patients to, of course, look at outcomes in this kind of indication.
So, we're very excited about this. I think it's these data that will tell us how to develop in the Phase 3 space. And ultimately, though, there is this excitement not only because of the mechanism, but because it's complementary, we believe, to the mechanisms that are out there, and ultimately, an opportunity to continue to make a difference in the HFpEF area.
Chris Shibutani
Let’s in the last few minutes transition over to milvexian, a pipeline asset that candidly got kind of blurry mixed reviews as we transition here. You're really trying to achieve something that's a pretty threading the needle kind of opportunity. Eliquis is fine drug. However, obviously, we can try to find some opportunity to roam by improving on the safety profile. You outlined opportunities, in particular for AFib versus Eliquis, the Librexia trial here. I think most investors at this point, when you talk about milvexian, it’s just like what do we need to see and when are we going to hear it? So, what do we need to see and when are we going to hear it? But in particular, for that one, are there elements of that trial that you think are important for us to know?
Roland Chen
Yes. With Librexia AF, again, you mentioned, Eliquis is a great drug, a great advance in this area, but there still remains unmet need, specifically a large proportion of patients still don't get treated or undertreated, for the reasons of real or even perceived risks of bleeding. And so we're very excited about milvexian as a Factor XIa inhibitor. And so we have kicked off the Librexia AF study. This is a very exciting study, where we're looking to enroll a broad representative patient population of AF, but of course, strategically enriched with certain risk factors. You can imagine through CHADS-VASc risk factors. And that allows us to also look at patients who have increased risks of stroke and bleeding who have AF.
And so, we'll be looking to see, the promise of this class is can you deliver efficacy that's at least as good as a Factor Xa, that is Eliquis, but with an improved bleeding profile. So what we'll be looking for is improvements in bleeding profile through various indices and looking for clinically relevant and meaningful differences in bleeding. I think when you think about it, we've also with Librexia, tried to develop a study that was simple, easy to enroll with criteria that don't rely on a lot of exclusions, for example, were necessary when we develop Eliquis. And so, we'll be looking for that. It's early days, but we're tracking according to plan, and we're doing everything to bring milvexian forward to patients as quickly as possible.
Chris Shibutani
So, enrollment is on pace with expectations?
Roland Chen
Yes.
Chris Shibutani
Okay. The '26, '27 time frame is kind of where we have the potential read out there. But can you remind me, are there any interims built in so that we might be able to get some sneak previews that got to be very informative?
Roland Chen
Yes. A few things about that, Chris. So, PCDs or primary completion dates, across our program, depending on the study, 2026, 2027, as you referred to, these are event-driven studies. And so even those PCDs can be varied depending on how the events actually occur, event rates and how enrollment, of course, occurs. But I think, as you know, we don't get into specifics about the interims, timing, or any of those details, typically. Chris, what I will say though is that we do build optionality into all of our studies. And I'll say we build that optionality in a way that we can read out these studies in accordance with regulatory guidance and such. And so, when you think about this, we'll continue on, we’ll continue to progress these studies forward, and you'll hear more about this in the future.
Chris Shibutani
And then the promised final question on IRA when most people say IRA and cardiovascular, if you're awake and alert you're thinking Eliquis, fine. But implications of IRA on cardiovascular development for you, sir?
Roland Chen
Yes. And it's actually a little bit -- I'm going to borrow a little bit from Lynelle here. I think, when you think about IRA, there is so much uncertainty, there are details that have to come out with IRA first and foremost. On the other hand, IRA is something as a consideration that we do have to take into account. Certainly, we do in sort of the scope of and context of all these other factors. But when you think about IRA inherently though, it still comes back to what is the unmet need that we're trying to address? Can we identify areas of great unmet need? And then, do we have the molecules and the targets to actually address that unmet need. Milvexian is an example of that. We do strongly believe that there's unmet need in ACS. We think that there's unmet need in SSP. We think there's unmet need, as we talked about, in AF. And so, that's the reason why we believe with the confidence in the molecule that we can develop this in a parallel path. And ultimately, in this case, hopefully, a few years down the road, be able to launch this in rapid sequence. That's one way of addressing that.
It’ll minimize potentially what we think might come forward with IRA. But again, it still goes back to the science because it's the belief in these targets, it's the belief in these indications and the unmet need and trying to bring something forward for you.
Chris Shibutani
Okay, terrific. We're at the close of our session. I always think with the large-cap pharmas getting the opportunity to explore conversations with bench depth with management teams is so important. The two of you have represented the mother ship of Bristol very well. Thank you for your helpful comments.
Lynelle Hoch
Thank you.
Roland Chen
Thank you.
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Bristol-Myers Squibb Company (BMY) Presents at Goldman Sachs 44th Annual Global Healthcare Conference (Transcript)