Legend Biotech at Morgan Stanley Conference: CARVYKTI’s Global Impact

On Tuesday, 09 September 2025, Legend Biotech (NASDAQ:LEGN) presented at the Morgan Stanley 23rd Annual Global Healthcare Conference. The company emphasized its strategic focus on expanding CARVYKTI’s market potential and advancing its proprietary pipeline. While the company celebrated CARVYKTI’s status as the top-selling CAR-T product globally, it also acknowledged ongoing challenges in clinical trials and regulatory engagements.

Key Takeaways

• CARVYKTI achieved $439 million in global net trade sales in Q2, becoming the leading CAR-T product worldwide.
• Legend Biotech is expanding manufacturing capabilities in Europe and launching CARVYKTI in multiple ex-U.S. markets.
• The company is focusing on community oncology settings in the U.S. for outpatient administration of CARVYKTI.
• Clinical trials are underway for solid tumors and in vivo CAR-T therapies, although timelines remain uncertain.
• Legend Biotech is collaborating with Johnson & Johnson on awareness campaigns to drive referrals.

Financial Results

• CARVYKTI Sales:

- Global net trade sales reached $439 million in the second quarter.

- CARVYKTI is now the top-selling CAR-T product globally.

• Ex-US Revenue:

- $81 million was generated from ex-U.S. markets in the second quarter.

• Market Opportunity:

- Approximately 100,000 patients in the U.S. are eligible for second-line treatment and beyond.

- 35,000 to 40,000 U.S. patients fit within CARVYKTI’s label.

Operational Updates

• Manufacturing Capacity:

- The Techland facility in Europe spans 220,000 square feet.

- The Obelisk site in Ghent, Belgium, is actively producing CARVYKTI.

• Market Expansion:

- CARVYKTI is available in 11 ex-U.S. markets, with recent launches in Germany and Spain.

• Community Oncology:

- More than half of CARVYKTI’s commercial use occurs in outpatient settings.

- Collaboration with Virginia Oncology Associates as a community-based site.

Future Outlook

• CARVYKTI Penetration:

- The goal is to treat 70-80% of multiple myeloma patients in community settings eventually.

• Clinical Trials:

- CARTITUDE-5 is expected to complete primary data collection in 2026.

- CARTITUDE-6 data readout is anticipated in 2030 and beyond.

• Pipeline Development:

- Focus on allogeneic therapies and in vivo CAR-T.

- Phase 1 trials for CD19/CD20 dual targeting in vivo CAR-T for non-Hodgkin’s lymphoma are underway.

Q&A Highlights

• Community Oncology Expansion:

- Legend Biotech anticipates increased outpatient use of CARVYKTI with the second-line launch.

- The company is exploring remote monitoring solutions using wearable devices for CRS management.

• First-Line Studies (CARTITUDE-5 and CARTITUDE-6):

- CARTITUDE-5 enrollment is complete, with primary completion expected in 2026.

- CARTITUDE-6 global enrollment is closed, with data readout likely in 2030 and beyond.

• Regulatory Strategy:

- The company plans to use PFS as the endpoint for FDA approval in the frontline setting.

- Engagements with global regulators are ongoing regarding the use of MRD as an endpoint.

For more detailed insights, refer to the full transcript below.

Full transcript - Morgan Stanley 23rd Annual Global Healthcare Conference:

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Great. Thanks for joining us, everybody. I’m Terence Flynn, Morgan Stanley’s U.S. Biopharma analyst. I’m very pleased to be hosting Legend Biotech today from the company. We have Ying Huang, the company’s CEO. Thanks so much for joining us, Ying. Before we get started, I have to read my disclosures. Please see the Morgan Stanley Research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. Again, thanks so much, Ying, for being here with us today. I thought maybe just to start high level, you could give us a little bit of an overview of kind of your strategic priorities, particularly as you’re approaching your goal of, you know, operational breakeven on CARVYKTI by the end of this year, as well as profitability in 2026.

Ying Huang, CEO, Legend Biotech: Sure. First of all, thank you, Terence, and also Morgan Stanley for inviting us. In terms of our top two strategic priorities, very clear, right? Number one, we want to maximize the market potential for CARVYKTI. On the heels of the recent data at ASCO, where we showed that up to a third of the patients who are in CARTITUDE-1, very sick, heavily pretreated patient population who actually can achieve five-year treatment-free cancer remission. Some doctors would actually take this as a so-called functional cure. By the way, this has never been achieved in myeloma because historically, multiple myeloma has always been accepted as incurable cancer. Patients cycle through different lines of therapy and eventually they succumb to disease. That is a very unprecedented, life-saving data for patients who are in fifth line beyond. Also, recently, we achieved the label addition in Europe to include the survival data from CARTITUDE-4.

We’re looking forward to actually the FDA label update in the near future for that label inclusion in the U.S. as well because last year we hit the first pre-planned survival analysis. We saw a very clinically meaningful and also statistically significant reduction of death by about 45%. That is against the standard of care, which is a three-drug cocktail, including DPd, Darzalex, Pomalyst, dexamethasone. All 10% patients in that standard of care also chose PVd, right? In fact, at a recent ODAC held by the FDA to discuss planned rep approval, Dr. Paul Richardson from Harvard Medical School and Dana-Farber Institute, he mentioned in one slide that in fact, in all second-line trials, CARVYKTI was the only drug and CARTITUDE-4 was the only second-line trial to show a drug is actually better in terms of improving survival over standard of care. That is very significant.

We intend to fully leverage that. We’re actually going to the community and directly promoting second line. Hopefully, in the near future, we’ll get the label update on survival, right? At the same time, we and Johnson & Johnson are also conducting two global phase 3 trials looking at frontline patients. Hopefully, in the next couple of years, we’ll start to get the first readout and then we can leverage this in the frontline. In short, we’re trying very hard to really bring this life-saving therapy to early-line patients as early as possible. Right now, we can do that in second line in both the U.S. and Europe. Eventually, hopefully, we’ll get positive data in the frontline. That is a big strategic priority, right? How do we actually deepen the penetration for CARVYKTI so that this immunotherapy can be accessed by many early-line patients in myeloma?

Secondly, we also want to fund our internal proprietary pipeline, right? We’re doing research in three large fields, right? The first one is a solid tumor. Recently at ASCO, we actually for the first time presented data for our DLL3 targeting CAR-T for small cell lung cancer. That is partnered with Novartis. We also published some data on the gastric cancer patients trial in the AUTO CAR18.2 trial. That’s one focus of the research. The other one is allogeneic. We still have quite a few active phase 1 programs running, including allo alpha delete, allo gamma delete, and also alloNK. I think the most recent entry for our research effort is the third area, which is in vivo CAR-T. As you can probably see from disclosure on clinicaltrials.gov, we’re now actively running two trials. Both are CD19/CD20 dual targeting in vivo CAR-T for lymphoma, non-Hodgkin’s lymphoma.

In fact, we have those patients already by now. We’re very actively pursuing that because we see that as an emerging new field for research in cell therapies.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay, great. I think we’re going to dig into both of those priorities here in the next 20, 30 minutes or so. You know, CARVYKTI posted a most strong quarter of growth here on a sequential basis. As we think about the forward outlook here on growth, you know, into 2025, 2026, can you talk about some of those drivers? I mean, you alluded to, you know, a couple of these in your opening remarks here, but how are you thinking about the sustainability of that momentum that we’ve seen so far coming out of the second quarter?

Ying Huang, CEO, Legend Biotech: Yeah. Recently in August, we reported our financial results for the second quarter. Just to reiterate, CARVYKTI brought in global net trade sales of $439 million. We’re also very proud that it’s the second quarter where CARVYKTI now is actually the biggest selling CAR-T product in the world, right? Hopefully, this will be the case for many more quarters and years to come that this will remain the number one selling CAR-T. That was really a big milestone for CARVYKTI. I think it’s also very important to say that CARVYKTI is the only CAR-T targeted BCMA for myeloma that’s got a second-line label and also with a survival benefit. We really intend to capitalize on that. If you look at the multiple myeloma market, right, in the U.S. alone, you’re looking at about a total prevalence of 190,000, right?

So 190,000 patients are the total patient number who unfortunately have been diagnosed with this terrible disease. Right now, in the second line and beyond market, we’re looking at a total addressable market of roughly 100,000 patients flow every year. Just in the U.S. alone, you’re looking at probably 35,000 to 40,000 patients who fit into that label. I would say, even though we have a very strong second quarter, we’re really just scratching the surface for these early-line patients in multiple myeloma. We still have a long way to go. We fully believe that with this one-time convenience and also the recent data from CARTITUDE-1 in terms of five-year follow-up and cure, as well as the second-line data survival improvement in CARTITUDE-4, a lot more patients will demand this therapy. It’s our responsibility to increase the supply so that many more patients can access this therapy.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: What? Can you walk us through kind of the ex-US side? We’ll unpack a little bit more on the US, but just where we stand on the ex-US side.

Ying Huang, CEO, Legend Biotech: Yeah. We’re seeing meaningful growth last quarter as well. Last quarter, I think we brought in about $81 million in total revenue. That’s becoming now a more important growth driver for CARVYKTI. Right now, we have a site in Ghent, Belgium. It’s called Obelisk, which is already commercially producing CARVYKTI under the approval from European regulatory authorities. We’re looking forward to, in the very near future, an official commercial license from Europe for our Techland facility in Europe to supply the European market. The Techland facility is going to be about a 220,000 square foot facility, state-of-the-art modern facility for CAR-T production. Right now, we’re approved only to use that site for clinical trial production. In the very near future, we look forward to commercial license approval there. That will take our revenue in Europe to another level.

Just to look at the second quarter, we’re already seeing very healthy growth that is coming from our production from the site in Ghent called Obelisk. We do have some limited slots. We’re deploying from the U.S. sites to supply the European market. So far, out of the five major EU markets, we have launched in Germany. Last quarter, we also officially launched CARVYKTI in Spain. In fact, we’re seeing a very good uptake. Right now, we’re already seeing a lot of incoming orders in Spain. We’re launching two major markets. In total, we’re now available. CARVYKTI is available in 11 ex-U.S. markets today. We hope that by the end of this year, we’ll continue to launch in additional markets. Hopefully, next year, we’ll launch at least one or maybe even two major European markets as well.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Can you frame for us? I know you told us the Techland site is 220,000 square feet. How big is Ghent on a sizing basis, square foot?

Ying Huang, CEO, Legend Biotech: Obelisk is much smaller in terms of square footage. We don’t discuss other detailed technical specs in terms of square footage. In general, I can tell you that we’re seeing a very significant upside in terms of the supply available from the Techland site versus the Obelisk site.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay, at least like tenfold?

Ying Huang, CEO, Legend Biotech: I don’t want to go into the most pointy line, but I would just say that it’s going to be one of the largest cell therapy production facilities in the world.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay, you said that’s near term, like heavy months?

Ying Huang, CEO, Legend Biotech: We have said that definitely in the second half of this year, we look forward to European approval for commercial licensing Techland.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay. Okay. Got it. Great. All right. Now maybe if we pivot back to the U.S. here, I know the other big effort is obviously you talked about moving to earlier line setting. That’s where the CAR-T4 label comes into play, but also this expansion into the community oncology setting, that’s pretty important. I think there have been a number of fits and starts, more so on the CD19 front, where we’ve seen some of these companies kind of face some challenges as they try to move out into the community oncology setting. Maybe you could talk about your and Johnson & Johnson’s strategy here to address some of those challenges that other companies have faced. As you think about any differences for myeloma versus lymphoma as we consider the ramp in the community oncology setting, where I think it’s what, 80% of myeloma patients are treated.

Ying Huang, CEO, Legend Biotech: Sure. First of all, we do believe that CARVYKTI has a unique profile. In all the trials we conducted to date, CARVYKTI has a very consistent median onset of CRS at about seven to eight days. That gives us a wide window, which means really there’s no critical need to hospitalize a patient in the first week or so. That is actually very unique compared to all the other CAR-Ts because typically a CAR-T would have immediate onset, like onset of CRS of one or two days. In that case, I think physicians are very shy about releasing the patient out of the hospital because what if CRS happens or ICANS happens? Then that patient needs to really come back to the hospital setting. That’s really not beneficial to either the physician or the patient itself.

In our clinical trial setting, because of this seven or eight-day onset, we knew that commercially, this could be one advantage because we all know that right now, most of the CAR-T administration happens in a tertiary teaching hospital setting. In the U.S., you’re looking at about maybe at a setting of 180 to 200 tertiary centers because you don’t have any more than that in terms of tertiary teaching hospitals around in this country. You’re limited by the number of sites. You’re limited by the number of beds those hospitals may have. In the case of CARVYKTI, we actually institute an outpatient program in the CAR-T program. We actually experiment different ways to do this. If you look at the protocol, typically when the patient is coming in for CAR-T infusion for CARVYKTI, it takes a few minutes for that drip infusion.

Then the patient will stay in the same facility for six hours for monitoring. If nothing happens, then the patient can check out. They’ll come back maybe daily for monitoring for the first 10 to 14 days. There’s no need to hospitalize that patient. Now we’re seeing in the commercial setting, in fact, we said on the third quarter financial earnings call that more than half of our use today in commercial setting actually happens in the outpatient setting. That is actually very consistent with what we saw in the clinical trials. We’re glad that we’re seeing the majority of patients are being able to be treated with CARVYKTI in the outpatient setting, which is very convenient, which means you don’t have to be away from your family or caretakers.

You can actually either go home if you live in the vicinity of the CAR-T center, or you can find a facility where you can stay overnight, but it’s not in a hospital setting, right? That’s what we’re seeing. In fact, we predict that with the second-line launch into the community, we should see even higher uptake of outpatient use for CARVYKTI. Recently, by the way, some abstracts came out from the IMS meeting, which will be held next week. There’s one abstract where they looked at, I think that’s so far the largest commercial real-world study for CARVYKTI. About 20 academic centers in that CIBMTR cohort registry published the abstract showing that out of 595 patients who received CARVYKTI commercially, the grade 3 or above CRS was only 4%, lower than what we saw in the trial setting, in fact.

That shows you that in the real-world setting, safety is actually better. Physicians know how to manage CRS. There’s no need to hospitalize a large number of patients, right? This is why we’re seeing this in the community. Now, to your second question, how do we deepen our penetration in the community? I mean, as you correctly and rightfully pointed out, really, other CAR-Ts have not seen much success in terms of going into the community, even though they may have the second-line label, right? On the second quarter financial results call, we did say that right now, actually, we’re basically seeing that the CAR-T4 patients, the second to fourth line patients in our revenue mix, account for about 60% of our revenue. Out of that, probably 70% are actually referrals from the community into the centers, right?

We’re doing a lot of work educating both physicians and also patients about the benefit of CAR-T and also the fact that you can actually get CARVYKTI in the outpatient setting. You don’t have to, hey, you have to stay in the hospital for two weeks, for example, right? That is a big benefit, I think, and also convenience for the patients receiving CARVYKTI. I think that’s a good advantage we have in terms of, you know, educating the second-line benefit for CARVYKTI patients here. We’re seeing that also we’re starting to see more and more referrals following the publication of the New York Times article talking about, you know, treating a lethal disease. Hopefully, some of the patients can potentially be functionally cured, right? That’s another, I think, tailwind we have because we’re seeing anecdotally patients are coming in. They’re calling their doctors.

They’re contacting their doctors, hey, I heard that CARVYKTI is approved in second line. Can I get that? I think we’re starting to see that benefit. Lastly, I want to mention that recently, we and our partner, Johnson & Johnson, started this direct-to-patient campaign. You can actually see this message on channels including Peacock, AWC, YouTube, for example, right? It’s a very targeted effort because we know that in the community oncology setting, the awareness of CAR-T is low. In fact, based on our survey, one-third of the community-based hematologists are actually not aware of CAR-T or specifically CARVYKTI, right? Even in that two-thirds of community-based physicians, they are aware, but so far, only half of those physicians have referred a patient to CAR-T treatment. Clearly, there’s a lot of upside opportunity here.

There’s untapped opportunity where we can educate those physicians about the benefit so that they understand the CAR-T benefit. They also understand how to treat a patient with CARVYKTI.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Maybe a couple of follow-ups there. The community setting, you said it’s about, or sorry, the outpatient over about half of your use right now. Where can that ultimately go over time, given some of these initiatives that you guys are instituting?

Ying Huang, CEO, Legend Biotech: Yeah. If you look at where the multiple myeloma patients are seeking care, right, typically in second line or second to fourth line in general, about 70 to 80% of the patients, they’re being cared for in a community setting. They don’t go to a tertiary teaching hospital such as Sloan Kettering in New York City, right? Eventually, I think, you know, we would expect that is also consistent with what we should see commercially. That is maybe 70 or 80% of patients should be treated in a community or in the vicinity of that community, right? That’s our goal. Obviously, we’ll see. We have a lot of education and hard work to do, right, because we also have to provide the logistic support when you help those centers use CARVYKTI in the outpatient setting.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Is there anything on CRS monitoring that you guys can do in terms of this outpatient setting? You mentioned onset seven to eight days, but I’d imagine it’s still stressful for patients and physicians if you are one of those people who unfortunately has those side effects. Is there something you can do from a remote monitoring basis to try to increase comfort?

Ying Huang, CEO, Legend Biotech: Absolutely. In fact, we in Johnson & Johnson are experimenting on a new approach where a patient can be sent home with a wearable device. That wearable device is something like, you know, an Apple Watch, for example, right? It does measure certain vitals, including body temperature, including the blood oxygen saturation level, because as you know, if a patient has a fever or the blood oxygen saturation level is low, those are the two telltale signs of CRS. We can actually see that signal remotely, right? It can beep on the signal to the hospital or to the monitoring centers. Therefore, we know even sometimes before the patient knows, right, okay, there’s a sign of CRS. We try to proactively manage CRS at a low level, right? Like, you know, grade one or, you know, grade two, but not anything above, right?

If you can pull those patients back, sometimes it’s as easy as give them some, you know, one shot of IR6 or some Tylenol or some other anti-fever medications, for example.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: When will be a timeline for like a broader rollout of that kind of thing?

Ying Huang, CEO, Legend Biotech: It depends how we see this turn out in the field, right? I would say, broadly speaking, unless you have a patient who lives in a rural area, which is really kind of far away from a center, otherwise, if they’re living within the vicinity, for example, one and a half hour driving distance, it may not be necessary to have such a device. On the other hand, if patients overwhelmingly say, you know what, we want that, certainly we can leverage that.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay. Great. And then just one more follow-up on the community side. You have this collaboration with Virginia Oncology Associates that you guys recently talked about. Maybe just provide us a little bit more detail about why that was the initial focus. Like, what was it about Virginia Oncology Associates that, you know, they decided to move in this direction with you guys? Then how are you thinking about, you know, leveraging the learnings from that to other centers? What are some of the metrics that, you know, we should focus on?

Ying Huang, CEO, Legend Biotech: Yeah. Even as recent as maybe 12 years ago, people would tell us, you know what, you guys can never use this drug outside the hospital. Forget about community even, right? We say no. We believe based on what we see in the clinical trial experience and also the fact that you have this unique seven to eight-day median onset of CRS, we think we can. We follow up with this and we announced in our second quarter earnings call that we actually officially signed up Virginia Oncology Associates as the first truly community-based site or customer to use CARVYKTI, right? Virginia Oncology Associates, they’re not a hospital chain. They’re actually a conglomerate that operates nine clinics in the state of Virginia. This is, like I said, truly community setting, right? Patients go in, they get the drug, and then they go home, right?

They don’t stay overnight in Virginia Oncology Associates. First of all, we proved that we can actually do this. Secondly, anecdotally, I can tell you one interesting story. One reason we go to communities is because we think that multiple myeloma patients as a group, they’re actually quite knowledgeable. I mean, I don’t know whether you try to read some of those online forums where they discuss treatments and outcomes, right? They’re actually very knowledgeable in terms of how they understand the science or which treatments are available in the commercial setting. Sure enough, the first patient who came from Virginia Oncology Associates, it’s actually through a patient inquiry. A patient walks in, asked the doctor, said, hey, I heard about CARVYKTI. Can I get CARVYKTI? Sure enough, the patient got CARVYKTI. I’m happy to report that we finished manufacturing. We shipped that drug, and the patient was infused already.

It shows you that, yes, you can actually go to community with this new technology called CAR-T. It doesn’t add too much burden for the patient because the patient can get treatment in his or her own community where they live, right? This is the first, but definitely it’s not the last. We and our partner, Johnson & Johnson, we’re engaging many different community-based clinics or group practices. We’ll continue to roll this out. I believe, in the future, we’ll have the majority of the patients who can actually get treatment in their community. There will be monitors and follow-up also in their community.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: What does that look like? I think you mentioned what was 180, 200 hospitals. Those are systems like Virginia Oncology, or that’s like an individual footprint number just to think about mapping this. How big is that set of potential similar facilities or healthcare providers, I guess?

Ying Huang, CEO, Legend Biotech: I think right now we have about 126 hospitals or centers like Virginia Oncology Associates that are certified to use CARVYKTI in our network. Going forward, I will continue to increase the tertiary hospitals in our network. As you just mentioned, we’ll probably push to that city maybe next year. You’ll reach your maximum of the tertiary centers. We’re not stopping there because we’ll continue to spend a lot of effort in going into the community, signing up more accounts such as, you know, Virginia Oncology Associates. There are a lot of regional clinics or even national GPOs, right? These are organizations that are in the community. They have a big number of, you know, sort of like chain stores, right? They all follow the standard protocol. Once you educate the whole chain, they can use that.

That is going to be our future business model to go to the community, to go to the second line.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Is this now, can this be a profit center for some of these community oncology centers, or is this more break even when you think about the reimbursement economics?

Ying Huang, CEO, Legend Biotech: I mean, we do believe it can be financially viable for those centers because, as you know, if you look at the total treatment cost for CAR-T, a big part of that is actually ascribed to the hospital cost, right? If you go to a CAR-T center, a tertiary center, and if it’s a patient covered by Medicare because he or she is 65 years or older, then under Part A, you get one single check. Apparently, many hospitals actually, unfortunately, lose money on that because if you calculate the cost for CAR-T drug and then the hospitalization, you probably know how much it costs, overnight, that stay in the hospital in the U.S., and all those periphery care. A lot of times, we have heard that maybe as much as half of the cases where hospitals can lose money because of that.

Now, because you’re omitting this hospitalization and you take a big part of that cost out, you can actually make that financially viable because you’re using existing square foot in terms of the facilities in the chain or in the clinic. You don’t need to add anything special. There’s not any extra cost of that.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay. Great.

Ying Huang, CEO, Legend Biotech: It’s most like a typical, you know, what I call the Part B medication.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: I just want to touch on a couple more CARVYKTI before we get to the pipeline. You mentioned the first-line studies that you guys are doing, CARTITUDE-5 and CARTITUDE-6. Obviously, there’s the transplant population, transplant ineligible population. You’re doing separate trials in both of these. Maybe just level set us with kind of enrollment and then remind us like data timing, what you guys have said. It sounds like you said something alluded to over the next couple of years or so. It sounds like we shouldn’t expect anything in 2026. I mean, it’s more of a 2027 type readout.

Ying Huang, CEO, Legend Biotech: I wouldn’t confirm that because, as you probably know, CARTITUDE-5 and CARTITUDE-6 are what we call event-driven trials. We have filed with the global regulators, including FDA and EMA. We need to hit a so-called certain prespecified number of events before we can unblind the trial. CARTITUDE-5 is done in patients who are either not eligible for transplant or they’re eligible, but they have decided to defer transplant because of, you know, convenience or other factors, right? We finished that enrollment a while ago, more than a year ago, and now we’re just in the follow-up period. The comparison arm is a standard of care called RVD. It’s a three-drug cocktail, including Revlimid, Velcade, and dexamethasone. What we have disclosed in the clinicaltrials.gov website is that the primary completion will be 2026. We don’t know exactly when, but broadly speaking, 2026, right? That’s what we have said so far.

Now, CARTITUDE-6 is another trial where we’re comparing CARVYKTI one-time treatment with a standard of care called DRVD for six cycles followed by Revlimid maintenance. In that trial, we’re planning to enroll a total of 750 patients, one-to-one randomized between CARVYKTI and the standard of care transplant arm. We’re happy to report that actually we already closed the global enrollment out of our planning, and right now, we’re just enrolling a separate cohort in Japan only for the Japanese approval in that setting. Right now, again, we’re in the dosing and follow-up period. I believe, you know, the data readout probably likely will be 2030 and beyond. Right now, it’s probably too early to talk about that because, you know, as you know, in those patients who are eligible for transplant, the median PFS can easily be, you know, five years or even longer, right?

That is why it’s not anything in the very near future. For CARTITUDE-5 right now, our disclosure on the clinicaltrials.gov website is that it’s going to be 2026.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay. You feel pretty good about that based on how events are tracking in CARTITUDE-5?

Ying Huang, CEO, Legend Biotech: We don’t talk about all these events. I think we’ll disclose when we have more clarity about the readout timing.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Yeah, just remind us, like, you know, RVD, what it did. I mean, that was back when probably you and I were both covering Celgene.

When the data read out, what’s the median PFS in that for that?

Ying Huang, CEO, Legend Biotech: Sure.

In the Celgene trial, registration trial that won RVD, the FDA approving in this setting, the median PFS was about 34, 35 months. About three years, right? Recently, if you look at the PERSUSE trial done by Jane Jay, I think in that trial, the control on RVD actually outperformed. It was at about 40 months PFS. Let’s just call it in that range of 35 to 40 months range, most likely.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: I know you guys generated some data. I think it was a CARTITUDE-2 study that you guys did in the frontline setting. That’s, I’m assuming, what gives you confidence to pull the trigger on these studies. Maybe just remind us, in that CARTITUDE-2 setting, what was kind of the key finding that gives you confidence that you can essentially beat this RVD benchmark that you just talked about?

Ying Huang, CEO, Legend Biotech: Actually, when we started CARTITUDE-5 and CARTITUDE-6 trials, we did not have any data, even internally for frontline at all. We did subsequently enroll and treated seven patients in CARTITUDE-2 trial. Those two cohorts are Cohort E and Cohort F. We have not published the data yet. The reason is you do need a pretty long follow-up because these are frontline patients, right? Six months or 12 months follow-up really is too short to show anything. That is why we have not published the data yet. We do have reasonable confidence that we should be able to have a positive trial because in CARTITUDE-1 trial, these are heavily pretreated sick patients, right, where the median prior lines was six and a half, right? Very sick patients. Still, we had a median progression-free survival that was 35 months and median survival that was five years, right?

We just published that at ASCO this year. For CARTITUDE-4, at this moment, we have not even reached the median progression-free survival yet for CARVYKTI. Suffice to say that it should be longer than that three-year mark we saw in CARTITUDE-1, right? We feel pretty good about the chance of winning in CARTITUDE-5.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Yeah. Okay. Understood. The last one I just want to ask on is just the latest on MRD negativity as an endpoint to accelerate timelines here. I know there’s new leadership at the FDA, but what’s your sense of where FDA is shaking out on this? Is that something that you guys are considering here for, I’m guessing, more so CARTITUDE-5?

Ying Huang, CEO, Legend Biotech: For CARTITUDE-5, the primary endpoint is progression-free survival or PFS. In CARTITUDE-6, we did put MRD as a potential and CR as a potential co-prime endpoint. Our base case has always been that we intend to go to the FDA using PFS as a clinical outcome here for approval. You’re right. In March 2024, FDA convened ODAC. They looked at MRD as a potential endpoint for multiple myeloma. In fact, the external experts on ODAC voted yes to recommend FDA to use or endorse MRD as an endpoint. I believe that FDA may take a more conservative stand on this. We continue to engage with the FDA on this. I can tell you that today, our base case remains that we would use PFS as the endpoint to go to the FDA to seek approval in frontline.

In fact, as you mentioned, under the new FDA, I think both Commissioner and also the Division Chief have said that they really want to see survival, not just only PFS, in any oncology trial. I think that shows you the emphasis from the agency in terms of demonstrating a survival benefit.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Yeah. Is there an opportunity with CARTITUDE-6 because MRD is a co-primary to have an interim look at that? Or is that not built into the design such that you’d have to kind of wait, wait longer?

Ying Huang, CEO, Legend Biotech: I think, first of all, we’ll continue to engage with global regulators, including both FDA and EMA, to discuss the possibility of using MRD as an endpoint. I must say, like I said, we continue to think that FDA is pretty conservative on this. In Europe, maybe EMA can be more open, but still, you’ve got to remember, right, in Europe, reimbursement is very important. EMA approval does not guarantee reimbursement. I can tell you, when you talk about reimbursement to all these healthcare authorities or country governments, right, they do want to see PFS or survival. It’s going to be difficult, I think, to use MRD to secure reimbursement in Europe.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay.

Ying Huang, CEO, Legend Biotech: That’s our baseline.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Got it. Just in the last couple of minutes, you walked through very nicely your pipeline. I’m sorry, we’re not going to take questions right now. Sorry. We’re going to talk about your pipeline. I know you outlined pretty nicely here what you’re focused on. I guess there’s been a lot of excitement around in vivo CAR-T, also allogeneic for autoimmune. As you think about these two programs, what’s kind of the next milestone that we should focus on?

Ying Huang, CEO, Legend Biotech: Sure. We do spend a lot of research effort in those two areas, right? Allogeneic, we have active phase 1 programs in allogeneic alpha beta T cell program. We have allogeneic gamma delta T program. We also have one allogeneic NK program that’s active now. I think the most exciting, you know, new area for research in cell therapy is in vivo CAR-T. You know, we actually started that effort a while ago, more than two and a half years ago. As just mentioned, it’s public information on clinicaltrials.gov that we opened two clinical trials in phase 1. Both are CD19/CD20 dual targeting CAR-T for non-Hodgkin’s lymphoma. Obviously, we think a lot about in vivo CAR-T. That’s what I would say. Right now, you know, we’re not in a position to disclose any data yet.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Is that a 26 event potentially, do you think?

Ying Huang, CEO, Legend Biotech: Potentially, yeah.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay. Okay.

Ying Huang, CEO, Legend Biotech: We do believe that we’re in a leading position at this moment, given what we know in the field.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Okay. What about on the allo side? Obviously, you know, more of a focus, I think, here on the autoimmune indications relative to cancer. How should we think about updates from your progress there?

Ying Huang, CEO, Legend Biotech: We actually probably first want to know how our allo T cells or NK cells perform in cancer first because, you know, if you can actually see efficacy in cancer, then more likely than not, you will see efficacy in autoimmune indications because the durability requirement is much higher in cancer treatment, right? I do think that, you know, we want to see a signal whether we can see good expansion. Once you see good expansion for the allo cells, does that lead to a durable cancer response or not, right? We will look into autoimmune indications. I do think that autoimmune indications have different safety requirements, also maybe cost, as well as, you know, the need for lympho depletion. These are all different needs in autoimmune, right?

This is why I think, you know, it’s a different model in terms of how you looked at safety, efficacy, convenience, cost, and everything.

Terence Flynn, U.S. Biopharma Analyst, Morgan Stanley: Great. Thank you so much, Ying. I think we’re up on time, but I really appreciate the thoughts today.

Ying Huang, CEO, Legend Biotech: Thank you, Terence. Thank you.

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