Hello, and welcome to the Lyell Company update call. We ask that you please hold all questions until the completion of the formal remarks, at which time you will be given instructions for the question and answer session. Also, as a reminder, this conference is being recorded today. If you have any objections, please disconnect at this time. I will now turn the call over to Ellen Rose.
Thank you, operator. Good morning, everyone, and welcome. Today, we will discuss Lyell's planned acquisition of ImmPACT Bio and our pipeline prioritization. Please review the press release and Form 8-K issued earlier today, which are available on our website at lyell.com. In addition, the supplemental slides discussed today are available on our investor website in the Events and Presentation section. Speakers on today's call include Dr. Lynn Seely, our President and Chief Executive Officer, and Charlie Newton, our Chief Financial Officer and Head of Business Development. Dr. Gary Lee, our Chief Scientific Officer, will join the call for Q&A. Before we begin, I'd like to remind you that during today's presentation, we will be making forward-looking statements that are subject to certain risks, uncertainties, and other factors that could cause actual results to differ materially from those referenced to in any of our forward-looking statements.
For a discussion of the risks and uncertainties associated with our forward-looking statements, please see our press release issued today, as well as our most recent filings with the SEC. We disclaim any obligation to update our forward-looking statements. With that, I'd like to turn the call over to Lynn.
Thank you, Ellen, and welcome to everyone joining the call. Today is a transformative day for Lyell as we announce the signing of a definitive agreement to acquire ImmPACT Bio, including their next-generation dual targeting CD19/CD20 CAR T-cell candidate, now in phase 1 clinical development for patients with aggressive B-cell non-Hodgkin lymphoma. This CD19/CD20 dual targeting CAR was elegantly designed by an expert team at UCLA to improve upon the complete response rate and duration of response observed for CD19 CAR therapy. The emerging phase 1 data suggests this product candidate has the potential to take significant market share in the second- and third-line. We look forward to presenting initial clinical data from this multi-center phase 1 clinical trial at a major medical conference this year.
Importantly, we expect IMPT-314 to enter into a pivotal trial in 2025 in patients in the third-line setting who have not yet been exposed to CAR T-cell therapy. At the same time we are acquiring ImmPACT Bio, we are also prioritizing our own pipeline to focus on our next-generation ROR1 targeted CAR T-cell product candidate, LYL119, in solid tumors. We have decided to discontinue further development of LYL797, our first-generation ROR1 targeted CAR, as well as our LYL845 TIL program, as they did not meet our criteria for differentiated patient benefit. As a result, we will streamline our operations to focus on our next-generation pipeline. We have a strong balance sheet to fund the company into 2027 through data milestones for each clinical program.
Since its founding, Lyell's vision has been to make advances for patients by developing T-cell therapies to address the biggest challenges to achieving better outcomes for patients with autologous cell therapy. Lyell remains committed to aggressively progressing the next wave of innovation of cell therapy for solid tumors as we move our next-generation product candidates forward. We are also now committing to rapidly bring an innovative cell therapy to patients with hematologic malignancies, with the aim of curing more patients and substantially improving outcomes overall. Lyell is building a pipeline of next-generation T-cell therapy. We have demonstrated dose-dependent clinical antitumor activity, robust cell expansion, and CAR T-cell infiltration into solid tumors in patients in our phase 1 clinical trial of LYL797, our first-generation ROR1 CAR T-cell product candidate. Our anti-exhaustion technology achieved enhanced tumor cell killing over historical control clinical data.
We have learned a tremendous amount from this program, but we are constrained in our dose escalation by a narrow therapeutic window in this first-generation product. We are now turning our attention to LYL119, which has more potent anti-exhaustion technology, enabling lower cell doses to be administered, and we believe the potential for a broader therapeutic window. The enhanced anti-exhaustion technology incorporated into LYL119, including c-Jun overexpression , NR4A3 knockout, Epi-R, and Stim-R, has the potential to achieve improved efficacy at lower cell doses with, we believe, an acceptable safety profile. The best way to preclinically evaluate counter-exhaustion technology is with a serial cell killing assay, where CAR T-cells are repeatedly exposed to plates of cancer cells serially over time until the CAR T-cells are no longer able to kill the cancer cells.
In this assay, serial tumor cell killing is significantly enhanced with LYL119 compared to LYL797, with a much greater duration of cell killing and persistence following repeated antigen stimulation, demonstrating the much more potent anti-exhaustion capacity of LYL119. In addition, LYL119 achieved complete tumor control and prolonged survival at a dose of only 100,000 cells, a tenfold lower CAR T-cell dose than was needed for LYL797, where 1 million cells were required in this validated in vivo model of non-small cell lung cancer. These data also clearly show the benefit of LYL119's additional anti-exhaustion technology. Finally, cell expansion at the lower LYL119 doses is more gradual while achieving similar peak expansion in vivo and may be associated with enhanced clinical tolerability.
The IND for this program has been cleared by the FDA, and site selection and activation are proceeding well. We expect to enroll the first patients with platinum-resistant ovarian cancer or relapsed refractory endometrial cancer by the end of twenty twenty-four or early twenty twenty-five. We will initiate the program with a low CAR T cell dose and then increase the dose with step dosing, which has been used successfully with FDA-approved bispecific T cell engager therapies to allow the immune system to gradually adapt to the therapy and reduce the risk of cytokine release syndrome, therefore, allowing higher doses to be administered with improved clinical benefit. Step dosing entails giving a low priming dose followed by additional doses.
We have also decided to discontinue LYL845, our tumor-infiltrating lymphocyte product candidate, because the initial clinical data in patients with advanced melanoma did not meet our rigorous criteria for differentiated patient benefit. In addition, our research-stage TIL and rejuvenation programs will be discontinued to focus on our next-generation CAR T cell program. We have learned a tremendous amount from these clinical efforts and want to thank the patients, caregivers, investigators, study staff, and Lyell employees for their contributions to advance innovative cell therapies to people with cancer. I am now excited to tell you about IMPT-314, an extremely promising and innovative CAR T cell product candidate we are bringing into our pipeline as part of our acquisition of ImmPACT Bio.
This product candidate has the potential to substantially improve clinical outcomes with more complete responses and longer duration of response for patients with aggressive B-cell non-Hodgkin lymphoma in the second and third-line settings. So why do patients need another CAR therapy for non-Hodgkin lymphoma? Because there remains a significant need for more patients to achieve complete responses with longer duration of response and longer overall survival. While CD19 CAR therapy represents a major advance in treatment, the fact remains that over 40% of those patients who do get treated with a CD19 CAR T therapy are not disease-free after treatment, and 30% don't even achieve partial response. Of the patients treated with CD19 CAR therapy, 50% progress or relapse within six months.
The overall survival at one year is only 50%-60%, and only 30%-40% of patients remain in remission at two years. The opportunity to bring better treatment outcomes to CAR-naive patients in both the second and third-line settings, in addition to the ability to potentially treat CAR-experienced patients, leads to a large patient population in need of a better CAR T treatment option. We are all aware that CD19-targeted autologous cell therapy has significantly improved the treatment for aggressive B-cell lymphomas, but this slide further highlights there is clear room for improvement. The three approved products are listed here, with Yescarta the current market leader in terms of overall sales. Yet, when you look at the data from their pivotal trial, ZUMA-1, in patients with relapsed refractory large B-cell lymphoma in the third-line setting, you see a 51% complete response rate.
That means 49% of patients did not achieve a complete response. Approximately 30% of patients didn't achieve a partial response. More importantly, the median progression-free survival in that study was only 5.8 months. While the safety profile is acceptable, there is a 9% rate of grade three or greater cytokine release syndrome and a 31% rate of grade three or greater neurotoxicity. In comparison, Breyanzi, which has a smaller overall market share, has a complete response rate of 54% and a median progression-free survival of 6.8 months, but with a 10% rate of grade three or greater neurotoxicity. There is clearly room to improve on objective response rate, complete response rate, and median progression-free survival. Dr.
Yvonne Chen and her team at UCLA set out to improve upon the efficacy and safety of the approved CD19 CARs by rationally designing a true OR logic-gated CD19/20 CAR. This means that the CAR can bind to either CD19 or to CD20 and elicits full potency as compared to either a single CD19 CAR or a CD20 CAR. Because there is no loss of potency in the CD19/20 dual targeting CAR, it would be expected to achieve a higher percentage of complete responses, particularly in those patients with lymphoma who may have a lower or heterogeneous CD19 antigen density. In addition, the UCLA team developed a manufacturing process to enrich for naive and central memory T cells by selecting for cells that are CD62L-positive cells.
CAR T cells generated from these less differentiated T cells are known to have better engraftment, improved persistence, reduced exhaustion, and lower cytokine production compared to CAR T cells generated from traditional processes. The decision was made to select for CD62L positive naive T cells, informed by an analysis from the ZUMA-7 clinical study in patients with large B-cell lymphoma. In this study, patients with a greater proportion of circulating T cells with a naive T cell phenotype had improved overall survival in comparison with those with a lower proportion of circulating T cells with a naive phenotype. Finally, a known mechanism of relapse following CD19 CAR therapy is the loss of CD19 antigen.
In this study, CD20 antigen depicted on the top row is stable following CD19 or CD22 single target CAR T cell therapy, indicating that a dual targeting CD19/20 CAR would be expected to have greater durability than a CD19 CAR alone, as CD20 antigen expression appears more stable over time compared with CD19 or CD22, and the data I'm about to show you from a phase I clinical trial at this dual targeting CD19/20 CAR demonstrates exactly that: a high percentage of patients with complete responses and responses of long duration. These data are from the single center, phase I dose escalation, UCLA investigator-sponsored trial led by Dr. Sarah Larson. In this trial, the objective response rate was 92%, with 10 out of 13 patients, or 77%, achieving a complete response.
Be sure to notice the x-axis with more than four years of follow-up in the first patients treated, and that some complete responses lasted for longer than four years. The patient with the longest complete response relapsed after four years, but importantly, remained CD19/20 positive and was recently retreated. Three patients in this study were treated with 200 million cells, five were treated with just 50 million cells, and three were treated at a dose of less than 50 million cells due to manufacturing issues at the Academic Medical Center using an earlier stage, less optimized process. Patients in this study had diffuse large B-cell lymphoma or an aggressive form of follicular lymphoma with a poor prognosis.
The initial data from this trial was published in Cancer Discovery in twenty twenty-three, were presented at the ASH twenty twenty-three annual meeting, and were more recently updated last week in an AACR special conference in cancer research, demonstrating impressive duration of responses over time as the data mature. Importantly, at the recent data update, with a data cutoff date of May twenty twenty-four, the median progression-free survival was 50.1 months, with the vast majority of these patients without evidence of disease. The median overall survival depicted here was not yet reached, and the three-year overall survival was 65% in this population of relapsed refractory aggressive B-cell lymphoma. The safety profile did not demonstrate any cases of ICANS, and there were no cases of cytokine release syndrome above grade one.
These data suggest this dual targeting CD19/20 CAR T-cell therapy has the potential to have a highly differentiated profile over approved CD19 CARs. This slide represents a very interesting case study of a patient with aggressive follicular lymphoma who was treated in the UCLA clinical study and developed a complete response by day 60 after receiving IMPT-314. The patient remained disease-free for 18 months. After relapsing, the patient's lymphoma was found to remain CD19 and CD20 positive, and the patient was retreated with originally manufactured cells. Remarkably, the patient again achieved a complete response 60 days after the retreatment. The successful retreatment is a very positive outcome for this dual-targeted CAR T therapy, particularly if replicated in the patient with a four-year response who received retreatment at relapse.
Based on the UCLA clinical data, ImmPACT Bio was formed, in-licensed the dual-targeting CD19/20 CAR program, transferred and optimized the manufacturing process, and initiated the multicenter phase 1/2 dose escalation, dose expansion study depicted here. The trial is enrolling patients with relapsed refractory, diffuse large B-cell lymphoma, and other aggressive large B-cell lymphoma subtypes, who have failed at least one or more lines of therapy. There are separate cohorts for third-line CAR naive, second-line CAR naive, and CAR-experienced patients. Safety, tolerability, objective response rates, complete response rates, as well as duration of response and translational data such as cell expansion pharmacokinetics are being assessed. Three doses are expected to be evaluated in the trial, including one hundred, two hundred, and three hundred million CAR T-cell doses prior to selection of the recommended phase 2 dose. There are approximately 15 sites open in the U.S., and enrollment is proceeding well.
We look forward to sharing initial data in third-line CAR naive patients enrolled into this trial at a major medical conference later this year. I will now turn the call over to Charlie Newton, who will discuss the key features of the acquisition we are announcing today and our upcoming milestones.
Thank you, Lynn. I'm thrilled to share the terms and strategic rationale for our acquisition of ImmPACT. For those of you that are less familiar with the company, ImmPACT was founded in twenty twenty-one based on clinical work conducted at UCLA with a CD19/CD20 dual targeting CAR T-cell therapy, which showed impressive efficacy in patients with relapsed refractory B-cell non-Hodgkin lymphoma, as Lynn described. ImmPACT subsequently initiated its own multicenter phase I clinical trial for IMPT-314, from which we plan to share initial results at a major medical conference later this year. Furthermore, we plan to initiate a pivotal trial in twenty twenty-five. The transaction significantly advances and de-risks our product pipeline with a program that leverages our clinical, scientific, and manufacturing expertise in CAR T-cell therapies.
314 possesses compelling clinical data and is on the verge of initiating a pivotal study targeting third-line aggressive B-cell lymphomas by improving upon the efficacy of approved CD19 CAR T and bispecific therapies. While we acquired ImmPACT primarily for 314's opportunity in hematologic malignancies, we plan to further assess the potential opportunity for 314 in autoimmune indications, as well as ImmPACT's earlier stage preclinical programs. While I suspect you have read our press release, let me spend a minute on the deal terms and structure. Lyell will be acquiring 100% of ImmPACT in exchange for upfront consideration, consisting of $30 million in cash and 37.5 million shares of Lyell common stock.
ImmPACT shareholders will also be eligible to receive contingent consideration, consisting of 12.5 million shares of Lyell common stock, upon achievement of a predefined clinical milestone and a low single-digit royalty on U.S. sales upon commercialization. As many of you know, worldwide sales of currently approved CD19 CAR T therapies are expected to surpass $3 billion in 2024, and are projected to grow to over $6 billion by 2030. Much of this growth will be driven by earlier use in the second-line setting, but also by greater availability to patients as more community centers, and not just academic medical centers, are treating patients with these therapies. Approximately 30% to 40% of patients with aggressive B-cell non-Hodgkin lymphoma relapse within twelve months following first-line treatment, and up to 65% have performance status eligible for CAR T-cell therapy.
The confluence of this large market opportunity, coupled with a product candidate, which we believe may have highly differentiated efficacy relative to currently approved CD19 CAR T-cell therapies, drive our enthusiasm for the potential of 314. Before we open the call for Q&A, I want to highlight our planned upcoming milestones, and to remind you that we have a strong balance sheet with $491 million of cash as of the end of the second quarter, which provides cash runway into 2027 through multiple clinical milestones. We are excited by the opportunity 314 has to become a highly differentiated therapy relative to the existing approved CD19 CAR T-cell products, and to capture a significant share in both the second and third-line settings for patients with aggressive B-cell lymphoma.
We look forward to presenting initial clinical data at a major medical conference later this year, and we expect to initiate a pivotal clinical trial for this product candidate in twenty twenty-five in patients with aggressive B-cell non-Hodgkin lymphoma in the third-line setting. For LYL119 , we previously reported clearance of the IND, and site initiation is proceeding well. We expect to enroll the first patient in this study in late twenty twenty-four or early twenty twenty-five, and plan to provide a progress update on this program no later than the first half of twenty twenty-five, and expect to present initial clinical data in the second half of the year. As a reminder, we are initially enrolling patients with ROR1 positive, platinum-resistant ovarian and relapsed refractory endometrial cancer in this trial. We are also developing CAR T-cell programs for solid tumors with undisclosed targets.
We intend to file our next new IND in 2026. Finally, while our primary strategic motivation for acquiring ImmPACT is the development of IMPT-314 in hematologic malignancies, we recognize the emerging clinical data and enthusiasm for CD19 CAR T-cell therapies in autoimmune indications, and thus intend to further evaluate the potential opportunity for IMPT-314 in autoimmune. That said, I would stress our top priorities in the near term are to advance IMPT-314 for hematologic malignancies and LYL119 in solid tumors. And now I'll turn the call back to Lynn.
Thank you, Charlie. Operator, please open the call for questions.
Thank you. At this time, if you would like to ask a question, please click on the Raise Hand button, which can be found at the back bar at the bottom of your screen. When it is your turn, you will receive a message on your screen from the host, allowing you to talk, and then you will hear your name called. Please accept, unmute your audio, and ask your question. We will give it just one moment for the queue to form, and we have our first question from Salveen Richter with Goldman Sachs.
Good afternoon. Thank you for taking my questions. Maybe just a first one here on the ROR1 CAR T, and just your thoughts as to LYL119 and how that'll be able to, you know, offset maybe some of the challenges you saw with the first-generation asset, and speak to the step dosing and how that comes into play here, with regard to optimization as well as the pneumonitis risk? And then with regard to IMPT-314, can you just help us understand, during your diligence process, kind of where you think this fits into the commercial landscape, where that unmet need is?
Absolutely. Why don't I get started, Salveen, and then maybe I'll toss it over to Charlie for IMPT-314. So in the ROR1 program, I think everybody is aware we have a first-generation ROR1 program, LYL797, which we've been studying. We've been very successfully able to show dose-dependent clinical activity, robust CAR T-cell expansion, and infiltration of CAR T-cells into the tumor, exactly what we hope to achieve with our anti-exhaustion technology. In the case of 797, that included c-Jun overexpression, and we also use our Epi-R technology. What we did find, we ran into pneumonitis, which we reported out in June, and we've been working aggressively to manage that.
But as we dose escalated, we really have come to understand that a significant portion of the market is, of course, in patients with lung metastatic disease, and that we weren't just going to have a broad enough therapeutic window with LYL797. And so we've been developing for some time, as you know, LYL119, which is our next generation CAR T-cell, which has four anti-exhaustion and Stim-R technologies. And what we've been able to show with LYL119 preclinically is that we can achieve complete tumor control in a non-small cell model, non-small cell lung cancer model, with much lower cell doses than LYL797. In fact, 100,000 versus with LYL119 versus 1 million cells or tenfold higher with LYL797.
So this has really potent anti-exhaustion technology, and what I mean is that it really extends the abilities of the cells to function over time. And we know this because we evaluate it with these serial cell killing assays, so that we basically expose plates of cancer cells to the CAR T cells, and LYL119 just works over and over and over again, substantially longer than even LYL797, which was better than, you know, just a standard ROR1 CAR alone. So those are two things that we're very excited about.
I think the third thing, which is important to mention, is because we start with lower dose, a quite low dose, the cells more gradually expand to peak, and so it gives us a little bit more of a window for the body, the immune system, to adjust to the cytokine release. And what we're doing, as we've cleared the FDA, the IND has cleared, sites are being activated, and we are using in this study something new. You may have heard of step dosing or step-up dosing, which has been used quite successfully in the bispecific T-cell engager field, where they've gotten to much higher doses by basically exposing the immune system to a low dose, a priming dose, and then days later, giving more significant doses to get up to a better therapeutic dose.
And so we're going to be trying that in the LYL119 program. It's also something CAR T fractionation has also been used and has shown to reduce CRS. So we're quite optimistic that we're going to be able to harness the cytotoxicity, the cancer cell killing activity of LYL119, get the better duration of benefit with hopefully an improved therapeutic window. So hopefully that answered your ROR1 part of the question. Charlie, you want to talk now about IMPT-314?
Sure. And Salveen, thanks for your time. Appreciate it. I think what I would say about the commercial opportunity is we think what really excited us about the asset was when we looked at the overall response rate, the complete response rates, and the PFS that Lynn went over during our prepared remarks, and you compare that against the existing CD19 therapies that are currently approved today. And if you look at that market opportunity, as you know well, it's about a $3 billion in sales market today, growing to about $6 billion by 2030. And so we think that this product has the opportunity to compete very favorably in both the second as well as the third line setting in CAR-naive patients.
Interestingly, it could have a role as well in CAR experienced patients, albeit not as large of an opportunity, obviously, as the naive patient. We're really excited about the opportunity and just feel as though this could be a much better product than the products that are on the market today.
Thank you.
Thank you. Our next question will come from Vikram Purohit with Morgan Stanley. Go ahead and ask your question.
Hi, can you hear me?
Yes.
Great, thanks for taking our questions. So we had two quick ones. First, for the phase 1, 314 update we're expecting to see by year-end, could you just frame for us the scope of the disclosure we could expect to see and what we can expect in terms of patient numbers and then follow-up? And then secondly, for the pivotal study expected to start in 2025, I know it's early days, but any sense of what that study design could look like and what the agency's requirements might be for 314 in that setting? Thank you.
Sure. So at this point, we're saying very little about what to expect at the major medical meeting, which will be coming up very soon, because before the end of the year. I think this will be the initial data presented on this trial, so we'll manage expectations about that. I think the nice thing is this is a continuation now in a multi-center setting of the UCLA study, the data that I presented you. And so the patients that are being enrolled are going to be primarily, or that are going to be included, are going to be primarily third line CAR naive patients, which is good and will be focused. This trial is enrolling patients with diffuse large B-cell lymphoma, primarily, and some other large B-cell lymphoma subtypes.
So that's what you could expect to see at the initial data public presentation. This will obviously, the story will continue to evolve over time. But I think we're stating loudly that we think that the data and certainly building on the data that have already been presented at UCLA, we believe we'll be taking these data to the FDA for an end of phase 1 meeting to move into pivotal trial in 2025, and we'll expect to start in the third-line or naive setting.
... Got it. Thank you.
Thank you. Our next question will come from Jason Zemansky with Bank of America. Please go ahead and ask your question.
Good afternoon, everyone. Thank you so much for taking our questions, and, congratulations on the deal. I was hoping you could speak a little more to the decision, specifically to bring 314 into the fold here. You know, at the end of the day, this is somewhat of a new tumor type, and while I certainly understand and recognize the opportunity and the differentiation here, you know, curious as to why expand into more hematological tumors, given the focus on solid tumors. Are there potentially developmental synergies here or mechanisms that you think you can leverage to facilitate advancing this through the pipeline?
I mean, at the end of the day, why not focus more on, you know, one one nine and the remaining TILs instead?
Thanks. Thanks, Jason, for the question. So from the very beginning at Lyell, the vision has been to address major unmet needs with autologous T-cell therapies. And yes, solid tumors has been and will continue to be a commitment that Lyell will be progressing new next generation CAR T-cell therapies for. And you see it in LYL119, you see it in the, the pipeline that we're alluding to, where we'll be bringing next generation solid tumor products candidates forward. So we're continued to invest and be excited about that. But this was just truly a really remarkable opportunity that we found, that we've been tracking for a while, and just became extremely exciting to us. And we recognize that the, the match between the two companies is really great. It's wonderful from a cultural standpoint, a patient focus standpoint.
We have a very similar high focus on science and data. We have great clinical development skills that we can bring to bear to help accelerate the work that they're doing, as well as manufacturing capacity. And so it really turned out to be just a terrific match and something that we're extremely excited about. And the quality of the data and the differentiated data really stand out, and we find ourselves very fortunate to be able to get such an asset at this time.
Got it. Thank you so much for the color. Thank you.
Thank-
Thank you. Our next question will come from Mitchell Kapoor with H.C. Wainwright. Go ahead and ask your question.
Hi, everyone. Thanks for taking the questions, and congrats on the deal. I wanted to know a little bit more about the potential pivotal design in terms of resembling or not resembling those trials from the approved CAR Ts in this space. Is there anything you can say to that nature, or specifically on duration, your cash you're expecting it to last into twenty twenty-seven. Would that fund the pivotal trial to completion, or is that still under consideration?
Yeah, why don't I get started and Charlie can finish up about the cash? So again, it's early days, and I don't want to overstate the facts about the design, but I think you can look at the history of the space and single arm trials in the third line setting have been acceptable. We believe that we're gonna be able to show to the agency differentiated data, and would hope that that would be the plan, at least for accelerated approval. So more to come on that.
Yeah, Mitchell, I would say just from a cash standpoint and how long that allows us in the study, it's a little difficult, obviously, to opine on that until we do know exactly what that trial design will be following our meeting with the FDA and be able to start that study. What I would say is we do expect that it would enroll very quickly, given how attractive the clinical data is that we have in the product today.
And so we're sitting with the cash that we have on our balance sheet today, and while I know we don't provide guidance on what our burn is, you can look historically what it has been, and we'll continue to be very diligent about trying to keep our costs under control, and that gives us plenty of cash into 2027, which we think will, at the very least, enable us to push very far into that pivotal study.
Great. Okay, and then on the commercial opportunity, can you just talk about how you see this opportunity with the current parties in the space, the Yescarta, Kymriah, and, you know, the opportunity to take market share versus grow the market? How do you see, you know, the commercial opportunity evolving, assuming that your profiled this therapy continues to kind of hold similar?
Yeah, maybe I can start a little bit, and Charlie can feel free to add. But I think, I believe that you can see from at least the UCLA data that we've shown you and the difference, how it's clearly differentiating from the approved CAR T-cell therapies. These sites, these physicians who are treating these patients understand what happens when they get this CAR, CD19 CAR therapy, and that too many patients either aren't responding initially or progress too quickly. And so if they're given the opportunity for a product that has a differentiated complete response rate and duration of response, and, you know, we'll see how the safety profile stacks up over time, that's yet to be determined, but it gives an opportunity to really, we believe, take market share. These physicians want the best products for their patients.
And then I think the other thing is, will this market continue to grow? And, Charlie, you might want to comment on that.
Yeah, we feel very good about the market continuing to grow as you look at just the, you know, consensus projections for the existing approved products expected to double over the next few years and continue to grow even further into the next decade. So we think it's a very significant opportunity to be able to pursue, and to do so with a highly differentiated product relative to those that are already in the market today.
Great. Thank you, and congrats again.
Thanks, Mitchell.
Thank you. There are no further questions at this time. I will now turn the call back over to Lynn for closing remarks.
Thank you all for joining us on the call. We look forward to updating you when the deal closes and on our progress moving forward.