Okay, I think we're ready to get going here. Thanks, everyone, for joining us again for our second annual Guggenheim Healthcare Innovation Conference on day two. I'm Vamil Divan, one of the bio-pharma analysts here at Guggenheim. Very pleased to have us join for our next session in this room. There's Johnson & Johnson. From the company, we have Sarah Brennan next to me, Group Chairman, Global Commercial Strategy Organization. And next to her, Mark Walgus, VP of Medical Affairs and Oncology. Obviously, tons to talk about. We had a great breakfast discussion for an hour. We have half that time here. We didn't even get that far in the breakfast itself. Let's just jump right in. I think we'll start on the oncology side.
We have a lot of exciting stuff across the portfolio going on right now, but a big approval recently in the bladder cancer side for Johnson & Johnson. If you can just talk about INLEXO and the early feedback you're getting from the field as this rolls out to the community.
Yeah, I'll start. Thanks for the question. Great to be here. We're super incredibly excited about the recent approval of INLEXO. Just taking a step back, our approval is within the non-muscle invasive bladder cancer. Annually, you see about 600,000 patients that are newly diagnosed and another 400,000 that have their bladder cancer reoccur. There hasn't been innovation really in four decades and 40 years. The approval of INLEXO really represents a tremendous opportunity for patients to move away from BCG, which is a very challenging current standard of care, as well as preserving patients' bladders because, unfortunately, they lose their bladders as part of the treatment. We have seen the highest complete response rates of 82% with this CISS population, which is a smaller, the first of several approvals that we expect to come. At 12 months, disease-free, which is incredible.
We also see the sustained delivery that's really making a difference of gemcitabine over a three-week period. It's the ingenuity of our med tech capabilities coupled with our pharmaceutical ingenuity to really deliver the sustained release of gemcitabine. The patient can go about their daily activities, which is a huge benefit. It is practice changing. We're seeing that firsthand in our early experience. Fits right into the urologist practice, easy to administer, and a procedure that they're very, very familiar with. Early experience, we got approval on September 9. Right out of the gate, we activated our supply chain team, our field force, our reimbursement specialists. We're seeing incredible receptivity, a lot of momentum, excitement, not only from the urologists, but also from the patients. They truly see this as transformational.
Yeah, and I think, Vamil, that first step for that first approval is phenomenal from that SunRISE-1 data. But we have more to come. We have two fully enrolled phase 3 studies, SunRISE-3 and SunRISE-5. SunRISE-3 in that high-risk, newly diagnosed setting, head-to-head against BCG, two active arms. That's INLEXO versus BCG and INLEXO plus our own PD-1 versus BCG. Really, it would be the first innovative BCG-free therapy in that newly diagnosed setting. And then we have our SunRISE-5 study, which is in those patients who are BCG exposed. Both of those are large patient populations. You can kind of get an idea of what that SunRISE-5 patient population data looks like from the cohort 4 of SunRISE-1. You're seeing high disease-free survival.
When you think about it, right between SunRISE-3, SunRISE-5, we really cover kind of that whole spectrum in that high-risk, non-muscle invasive bladder cancer setting. We also have our TAR-210 sustained drug delivery system as well, both MoonRISE-1, which is in that intermediate-risk setting, which is another third of patients in that non-muscle invasive bladder cancer setting, and then also MoonRISE-3, which is in that same SunRISE-5 patient population on BCG-exposed using that FGFR targeting perspective too. We really do cover the majority of patients with bladder cancer in that localized disease setting. Okay.
That's great. You've obviously talked about this being a $5 billion-plus type opportunity for Johnson & Johnson. We do get some questions on how to think about the initial sort of uptake and also the breakdown across different types of providers, settings, whether it's academic, large groups, or the kind of more community-based urologists. How are you thinking about sort of the profile across those three settings? The sort of initial uptake, and you're still rolling out, obviously, you got approval in a small group. You have a lot more data to come. It's a long-term play here. How should we think about the next year, a couple of years in terms of the initial uptake?
Yeah, I mean, we're seeing adoption across academic, large urology practices, smaller, deeply embedded into the community. As we mentioned, it's really seamless. It's very integrated into the urologist practice. As they become very familiar with this first indication, it's just going to help accelerate as we continue. We're just really, really excited about the platform, the TARIS platform in general, but specifically in non-muscle invasive bladder cancer. As Mark described, I mean, if you think about it, our development program covers the majority of non-muscle invasive bladder cancer. 75% of overall patients are in that non-muscle invasive bladder cancer, and then 50% are high risk. We see intermediate about 30%. End to end, we're really looking to bring this transformational innovation with subsequent indications.
Okay, so there's a lot of products I want to talk about. There's a lot we can go a lot more to talk about on the TAR-200. I want to touch on a few others and then maybe we'll come back to them. Because RYBREVANT, you've made a lot of great progress there. It may be the latest around getting the subQ formulation approved here in the U.S. Also, I think kind of any insights you can provide on the uptake you're seeing in the lung cancer space. It sounds like your commentary on recent earnings calls has been pretty positive on the adoption even before the subQ formulation arrived.
Yep, yep. Maybe I'll talk a little bit around, first of all, we're super excited about RYBREVANT and Lazertinib. We're seeing great momentum in the market. We are the first and only chemo-free regimen for frontline use. We're really focused on that durable overall survival as well as preventing resistance. It's very important in lung cancer because patients do develop resistance with the current standard of care. We are really poised for this to become the new standard of care. What I can say, we're focused on changing that trajectory of that five-year survival rate. What we see today with the IV in market, we have the highest intent to prescribe. The number one regimen intent to prescribe, RYBREVANT and Lazertinib. We have the highest unaided awareness. Every one in four patients are on a Johnson & Johnson Innovative Medicine regimen for lung cancer.
We're penetrated across all of our key sites and centers. Rybrevant subQ will be another catalyst for us and enable us to get even deeper and accelerate the utilization of Rybrevant and Lazertinib. We're now really talking about how the market is moving to combinations. Maybe Mark can build a little bit on that.
Yeah, Sarah, it's a good point because you've really seen a shift. The World Lung Cancer Meeting happened earlier in September. If you think about EGFR, non-small cell lung cancer, single-agent monotherapy pills, TKIs have really been the standard of care for the last 15 years. That's very, very much entrenched. Coming out of the World Lung Congress, you now have two combination phase 3 studies that have proven that you have a superior survival benefit versus monotherapy TKI. I think the era of monotherapy TKI is over. I think we're really in that combination realm. I think the question now is, which do you pick? Do you pick two old treatments together, or do you pick one new regimen?
Do you pick a regimen that changes the biology and changes the outcome, that targets EGFR, prevents the resistance forming, that harms the immune system, or do you use chemotherapy with a TKI? I think that's where I think the marketplace is kind of readjusting. I think, one, I think you're going to have to see the marketplace say, the physicians are saying, I really like EZ. EZ is a set of pills. EZ is also an order sheet which says, hey, nurse, please give my patient chemotherapy. I think there's a reshifting there of saying, okay, I really need to think about how do I optimize that outcome. I think that some of the initial feedback from RYBREVANT was, okay, I'm still learning how to deal with some of these infusion-related reactions. Okay, I figured that one out now. Oh, I see some skin-related reactions.
Now we've put out the Cocoon regimen. They're getting very comfortable with that. I think, importantly, with the subcutaneous administration, you now give a patient and a physician the simplest and fastest administration of a combination, which then harnesses that, changing the biology and resetting the long-term outcome. I think that's where we're seeing that shift in the marketplace of them moving away from what they did to what that new regimen is going to look like.
Yeah, and we're seeing growth both in the front line as well as we see growth in the second line because we're seeing patients develop these resistance.
Okay. Obviously, lung cancer is the focus now. I thought very interesting data at ESMO from RYBREVANT. Maybe you can just touch on the head and neck data, the opportunity there, and then colorectal is another dimension.
Yeah, Vamil, when you think about FGFR, or when you think about EGFR, there are definitely other malignancies where EGFR is a really important driver. Head and neck is one of them. Most of those patients, particularly HPV-negative patients, EGFR is a real driver for those patients. It is a real medical emergency for those patients. We are really excited to present the Aragami 4 data, the cohort looking at just RYBREVANT alone, subcutaneous in those patients with recurrent and metastatic head and neck cancer. You see more than 45% with objective responses, and then more than 80% of those patients are actually having disease reduction. Put that into context for a second. Current standard of care in that second-line setting with therapy, you are talking about somewhere in about the 10% range. When you think about durability, it is not very durable as well.
When you think about the current standard of care for patients with head and neck cancer, it's typically chemotherapy or chemotherapy plus a PD-1, response rates are about 36% in terms of that. To see a 45% response rate with RYBREVANT in that recurrent metastatic setting really sets the scene for us. We're going right after EGFR. We're blocking MET again. We're harnessing the immune system. We just announced at the ESMO meeting our Aragami 5 study, which is going to be the new first-line study that we're going to be looking at in head and neck, looking at chemo pembo plus AMI, head-to-head against chemo pembo. We think that that has the potential to kind of reset expectations there. Colorectal cancer is the same. We have Aragami 2, which is our frontline study in left-sided wild-type disease.
That study is enrolling incredibly fast across the United States and around the world. We also have our recurrent study in the second-line setting as well, the Aragami 3. We know in colorectal cancer that EGFR is an important pathway as well. It makes sense for us to go right after that. I think, Vamil, one of the other things too is that when you think about medical oncologists today in the community setting, they're treating lung cancer, head and neck cancer, colorectal cancer. I think that broader kind of array of the portfolio for RYBREVANT, it's going to fit right into the pocket of those physicians who are treating those EGFR-driven diseases.
Okay, that's great. I want to shift gears again. Still within oncology, but obviously, multiple myeloma is a massive area for Johnson & Johnson. Have to sort of talk about it. The couple areas I want to just get your thoughts on here. One on CARVYKTI, I think we're seeing nicer uptake. Obviously, manufacturing issues seem to be essentially behind you at this point. How do you see that sort of path moving forward? We get some questions on the bispecifics, which I think you've talked about being very bullish on. The commercial uptake, I think today has not been maybe quite as much as we thought. There's been some changes around the dosing intervals and stuff that played a role. Just hear kind of what you see for CARVYKTI and the bispecific portfolio sort of going forward.
Yeah, maybe I'll start on CARVYKTI, and then we can move to the bispecific. As you mentioned, CARVYKTI's been incredible in terms of what it's delivering for patients. We share data on CARTITUDE-1, and we see that 30% of the patients are disease-free at five years. It is really incredible. We continue to grow with CARVYKTI. We've expanded our sites in the US. We've also launched in 14 countries. We've treated over 9,000 patients worldwide, and we continue to see incredible growth. The team, from a manufacturing perspective, has done a phenomenal job. We are meeting the demand, the growing demand in the US, outside the US, and seeing incredible growth. Really, over half the growth is coming from the community setting. We've really been able to offer this to so many patients on a worldwide basis.
We are planning to launch in even more countries and continue to expand. It has been a big success rate. We continue to be seeing it be a very critical treatment option for patients. I do not know if you want to add anything on CARVYKTI, but then we can talk a little bit about bi-specific.
Yeah, I think, Vamil, with CARVYKTI, we're resetting expectations. We're now starting to talk about cure for the first time and the potential for cure in the myeloma setting. And that is really coming from CARVYKTI. I would say on my side, I'm super excited about publishing New England Journal of Medicine. But actually, this summer, we saw a simultaneous New York Times article, which was kind of interesting. But you actually talked about that idea from hospice to hope, where you're really talking about these patients who had a median of six prior lines of therapy. A third of patients with one single dose are alive at five years. Just to kind of ground people again, median survival in that patient population before CARVYKTI was approved was 12 months. Now you've got a third of patients who are alive, no disease left at five years.
You see that plateauing of the curve that is indicative of CAR-T. I think we're resetting the expectations of efficacy when you think about CAR-Ts in myeloma as the curative potential. I think anyone following us, anything on an efficacy perspective, CAR-T is the benchmark.
Yep.
The bi-specific.
Yeah, I wanted to, we are very excited about Tecvayli and Talvey. Tecvayli has been the most successful bispecific launch overall. We are really pleased. We are obviously seeing continued momentum. We have seen over 20,000 patients being treated worldwide. We have the lowest rates of discontinuation. We are continuing to garner additional experience in the community. That is accelerating our momentum and our growth for Tecvayli. Talvey is also growing nicely. It is actually the fastest-growing molecule in its approved indications. You have the flexibility of using it before BCMA or after. There is a lot of opportunity there. Again, we are garnering additional experience in the community and seeing that continuous growth. We also obviously have some, we recently announced some great anticipated data on a combination regimen, which is really going to accelerate the utilization of the bispecifics into the community.
Maybe Mark can talk a little bit about that. It's very exciting.
Yeah, just a couple of weeks ago, we announced in a press release that we reached the primary endpoint for the Majestic-3 study, which is TecDARA versus Darapom DEX or DaraVelcade DEX. We announced that we met the primary endpoint of PFS. We also included in that press release that we also saw survival benefit as well. We now know that TecDARA has a proven survival benefit in that early lines of therapy. I think the thing that I think is good to just kind of keep in mind with Tec and Dara, in that schedule, Tec is dosed with Dara. We use the Dara schedule. It is a fully subq regimen. I think when we saw with Tecvayli coming out, first of all, we saw people playing with the dose, playing with the schedule.
I think perhaps that's kind of had some impact on some of the usage. Here, we anticipate that people know exactly how to use Dara. It's going to be fit with Dara, TecDARA. It's going to fit right into that community setting. It's built for the community. It's built for the community that we now know how to manage CRS, which means that patients can get started without worrying about hospitalization. We know how to manage infections because we've seen how to use IVIG. I think that that regimen of TecDARA is really going to fit perfectly into the community setting. I think you're going to see that rapid uptake clinically because the data are going to be transformative. Okay. In the last sort of six minutes here, do you want to move away from oncology?
Because you have something to say, stuff outside of that too. The big one, I think, for us, at least, I go to Kindra.
Yes.
Now filed. Again, one of the big pipeline products that you're highlighting. Can you talk about how you see that sort of entering the market?
Sure.
Obviously, psoriasis is an initial indication, but then IBD. Is this a market expansion opportunity, or do you see it sort of pulling from some of the other advanced therapies that are out there now?
Yeah, no, great question. We are extremely excited about JNJ-2113. It is really, we've seen this become just an unprecedented combination of complete skin clearance in psoriasis, favorable safety profile, and an easy once-daily oral pill. We have a tremendous opportunity to expand the market for psoriasis. If you think about today, about 60% of patients are eligible and either not taking a systemic treatment or they're not on an advanced systemic treatment. If you think about this oral, JNJ-2113, where from market research, the majority of patients prefer orals, and they're cycling through topicals and not necessarily on a systemic, you can imagine this can be truly the frontline systemic treatment of choice to expand that market in psoriasis. It is truly an expansion opportunity. We are really looking forward to delivering this product with this type of combination.
It's going to be a real game changer for patients with psoriasis. You mentioned IBD. We also have data from a phase two study that we're leveraging to initiate our phase three programs in IBD, both ulcerative colitis and Crohn's disease. We see tremendous opportunity to also expand the market with I go to Kindra and IBD.
Okay. And then not to leave out another big approval you recently had was Caplyta, also a $5 billion opportunity for J&J. This is for adjunctive treatment of MDDs. As you think about the $5 billion, and I know you don't break it up by indication, how important is the adjunctive MDD opportunity within the broader Caplyta?
Yeah, first, we're very excited. We got the approval Wednesday of last week, and we were ready to go on Thursday. It is very important. First and foremost, Caplyta already was approved and has an indication for bipolar I and II, both mono and adjunctive treatment, as well as schizophrenia. You add the adjunctive major depressive disorder indication on, it is really important and incredible for patients and prescribers. In the U.S., there are 22 million people with depression or with mental health. Mental health is a major issue, not only in the U.S., but also globally. One out of two patients that are on an antidepressant have residual symptoms and issues. Having this adjunctive treatment for major depressive disorder is very, very important. It really resets the treatment expectations.
We have data from a long-term study that shows that 80% of patients had a response, and 65% of those at six months are in remission. It is an incredible opportunity. I think the prescribers really see the benefit of having all of these indications as they're treating patients with different types of conditions. We couldn't be happier and more excited for patients. We certainly see this as one of our $5 billion-plus assets coming out of our Intra-Cellular Therapies acquisition.
Maybe just one more follow-up on Caplyta. I think we've got some questions on, as you already have, obviously, these other indications. Is there a lot of work to sort of do with the payers to get access for patients in MDD, or should it be relatively seamless because it's already out there?
Yeah, it's already been out there. You can imagine it's really going to be integrated into what is already established. We continue to be very confident in our ability to enable access for a broad patient population. Looking to find opportunities to expand even beyond the U.S. into other markets as well. Very, very excited.
Okay. All right, great. I think we'll leave it there. Thank you so much again to the J&J team for joining us. Obviously, a lot of excitement led us to upgrade chairs a few months ago, just given all the progress you guys are making on the pipeline here. Great to see you. We'll be watching closely over the next year.
Thank you so much for having us. We appreciate it.
Thanks.
Thank you.