NovoCure Limited (NVCR) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the METIS Conference Call. [Operator Instructions] Please note that today's conference may be recorded. I will now hand the conference over to your speaker host, Bill Doyle. Please go ahead.

Good morning. This is Bill Doyle. I'm the Executive Chairman at NovoCure. Thank you for joining us today as we discuss the exciting top line results from the METIS trial. NovoCure announced this morning that the Phase III randomized METIS trial studying TTFields with supportive care for the treatment of brain metastases from non-small cell lung cancer met its primary endpoint. Patients in the TTFields fields arm achieved a 21.9 month median time to intracranial progression compared to 11.3 months in the control arm. The results were statistically significant with a P-value of 0.016 and a hazard ratio of 0.67. Patients treated with TTFields also experienced sustained neurocognitive function and quality of life without an increase in systemic toxicity. We are very pleased with the outcome of the METIS trial and what these findings could mean for patients in clinical practice. Our team's willingness to pursue indications that are difficult to treat and represent a significant unmet need are a point of pride for all of us at NovoCure. In a moment, I will pass the call to our Chief Medical Officer, Dr. Nicolas Leupin, who will discuss the trial in more detail. We will then welcome Dr. Naren Ramakrishna Director of Adult Pediatric Neuro-Radiation oncology and Proton Therapy Programs at the Orlando Health Center Institute to provide his perspectives on the METIS results. We will then open the line for your questions. Before I pass the call to Dr. Leupin, I'd like to take a moment to introduce NovoCure to those of you who may be new to our company. NovoCure was founded over 20 years ago with the mission to bring our unique electric field-based cancer therapy, we call Tumor Treating Fields, to patients with difficult to treat solid tumors. We have built a foundational business treating glioblastoma, which generates over $500 million in net revenue annually. 2024 is a pivotal year for NovoCure. We are on the threshold of potentially expanding our commercial portfolio into non-small cell lung cancer based on the successful Phase III LUNAR trial in patients after platinum failure, pending regulatory approvals. We hope to launch our next-generation GBM arrays in the U.S. following our successful launch in Europe. And later this year, we anticipate top line data from the Phase III PANOVA 3 trial in locally advanced pancreatic cancer. This is an exciting day for our company, and the first of many announcements we look forward to sharing with you this year. With that, I will turn the call to Nicolas to discuss the METIS trial and results in more detail.

Thank you, Bill, and thank you all for joining us this morning. My name is Nicolas Leupin. I joined NovoCure in January as the Chief Medical Officer. Some years ago, I was treating exactly those patients in trials like METIS, one of the reasons I was so keen in enjoying the NovoCure team, and I'm honored to share this data with you today. Let me first discuss the disease state and treatment landscape for brain mets from non-small cell lung cancer. As many of you know, metastatic non-small cell lung cancer is incredibly prevalent with over 100,000 Stage IV patients in the U.S. alone each year. This number, which is also on the rise as advancements in the systemic treatment of the primary tumor can extend live but are limited in their ability to hold metastatic spread. Approximately 25% of patients with NSCLC have brain metastases at diagnosis and the lifetime risk of a patient developing metastases in the brain is approximately 50%. Once brain metastases are found, the prognosis is quite poor, further impacting diagnosis is the serious impact brain metastases can have on a patient's quality of life, which can affect the patient's modest skills, speech, mood and cognitive ability. Despite the serious nature of the disease, treatment options are limited. Patients may have an initial surgical resection and then there are generally 2 avenues for treatment, stereotactic radiosurgery and whole brain radiation. Stereotactic radiosurgery, or SRS, is the first line of defense in which precise dosage of radiation is focused to remove metastases. SRS is effective but there's little to control formation of spread of new metastases and often requires repeated SRS procedures. Once metastatic spread has become too much for SRS to control, physicians will initiate whole brain radiation therapy as a last resort. Whole brain radiation can have devastating side effects as highly neurotoxic radiation is delivered to the whole brain. Let me now share more details of the METIS study and the clinical results. METIS is a Phase III open-label, randomized trial, evaluating the safety and efficacy of TTFields therapy and supportive care versus supportive care alone following stereotactic radiosurgery. Patients could have between 1 and 10 metastases from non-small cell lung cancer that met certain size criteria. Patients with known driver mutations prior whole brain radiation or significant comorbidities were excluded from the trial. 298 patients were enrolled in the trial across the U.S., Europe and Asia. We completed enrollment in early March 2023 and the 12-month follow-up period reached conclusion earlier this month. As Bill stated, the METIS trial met its primary endpoint time to intracranial progression. Patients treated with TTFields and supportive care demonstrated 21.9 months median time to intracranial progression compared to 11.3 months for patients treated with supportive care alone. This equates to a hazard ratio of 0.67 or a 33% reduction in risk of intracranial progression. The P value reached in the trial was 0.016, which is statistically significant. Baseline characteristics were well balanced between arms. And consistent with previous studies, TTFields therapy was well tolerated. Preliminary analysis of key secondary endpoints, specifically tied to neurocognitive failure, overall survival and radiological response rate did not demonstrate statistical significance. We did see a positive trend in time to distant progression and quality of life and neurocognitive function were sustained. Further analyses of these data are ongoing, and we intend to share the full data set at an upcoming scientific congress followed by a publication in a peer-reviewed scientific journal and submission of data to regulatory authorities in our key markets. We are incredibly proud of this data, and I would like to express my thanks to the patients and investigators involved in the METIS trial prior to my time at NovoCure. It is an honor to share these exciting results with you all today. I would now like to turn to our esteemed guest, Dr. Naren Ramakrishna, to provide his initial reactions to the METIS data. As Bill shared, Dr. Ramakrishna is the Director of Adult and Pediatric Neuro-Radiation Oncology and Proton Therapy Programs at the Orlando Health Cancer Institute and one of our leading METIS investigators. Dr. Ramakrishna, thank you for joining us. I was hoping you could please introduce yourself, share more about your role and tell us your overarching reactions to the METIS data.

Thank you very much, Nicolas. So my name is Naren Ramakrishna and currently, as mentioned, I'm a Director of Adult Neuro-Radiation Oncology and Pediatric Neuro-Radiation Oncology at Orlando Health Cancer Institute. Previously, I was the Co-Director of the Brain Tumor Program at Dana-Farber Cancer Institute and Brigham and Women's Hospital in Boston. I was one of the participating investigators in the METIS trial. And I would like to express my real, I would say, enthusiasm regarding these very important results, which I think can have a big impact on this critical patient population. So I wanted to bring up just the patient population, which is -- which Nicolas has touched upon, but these are lung cancer patients without driver mutations. And so they are a particularly high risk group of patients because systemic therapies are not effective for them for their brain metastatic disease as they might be with certain driver mutations and their systemic disease tends to also be quite aggressive. Brain metastases are a huge clinical problem that I face every day in the course of clinical management. These have a dramatic impact potentially on the quality of life of patients. And so when the trial was proposed, I was quite excited about this idea of being able to reduce the frequency of brain metastatic disease incidents in these patients. Now over the last decade, we've become increasingly reliant on a modality we call stereotactic radiosurgery to treat brain metastases patients in general and certainly for the non-small cell lung cancer group. And we've largely replaced the use of whole brain radiation treatment for those presenting with discrete brain metastatic disease that is not displaying in diffuse patterns, spread, et cetera. But even the use of stereotactic radiosurgery, though it has improved quality of life outcomes, for these patients relative to whole brain treatment, is fraught with certain challenges and complications and these challenges and complications have actually increased over the last 5 to 7 years as we have begun treating these patients with immunotherapy as well as other systemic agents which accentuate the risk of these local therapies in the brain. So in the METIS trial, patients presenting with diagnosed brain metastases were treated with stereotactic radiosurgery as we would do generally. But what we observed here, which is so important for clinicians like myself is that the time to intracranial progression was substantially increased using the TTFields device. And this is very important to me because this means that it would reduce the need for additional therapy for these patients And if one looks at that median time of 21.6 months, that is an enormous amount of time when one considers the overall prognosis of these patients and would be expected to have a really large impact on quality of life. And in fact, the secondary endpoint that was analyzed on preservation of function or deterioration of free survival supports that notion. So I think that these are some of the thoughts that I have regarding the clinical importance of these results. I think that it will be quite interesting to see how we can incorporate this type of treatment into our clinical armamentarium. And I think that this offers really important possibilities. There's 1 other thing that I wanted to point out. I've been discussing the primary endpoint time to intracranial progression, which is really the appropriate endpoint for a study like this. The use of overall survival for local therapy trials for brain metastases is not particularly helpful because the likelihood that the brain metastatic disease is the driver of survival is relatively low. It would be between 10% and 20% typically for a mixed population of patients like this. And so the impact on survival would be expected to be undetectable or modest at best. So I think that it's quite important to understand that the primary endpoint here was the critical and most clinically important endpoint in the way that we evaluate local therapy for brain metastases.

Excellent. Great. Thank you so much, Dr. Ramakrishna for explaining to us why those results are so important and also help us contextualize the overall survival versus the intracranial . Now help us to understand, if you had to describe one typical patient, who would benefit from these results today?

This is a great question, Nicolas. And the challenge of treating this patient population extends from the brain to the body and the patients without driver mutations of non-small cell lung cancer are an extremely challenging set of patients to control disease. And extracranial disease control in these patients is typically not as good as those patients who do have these driver mutations. And when extracranial disease is not controlled well, then there tends to be this constant risk of seeding the brain with the new metastases. So when a patient presents with brain metastatic disease in the setting of metastatic driver mutation free non-small cell lung cancer, then this is a modality that I would give strong consideration to so that one could then reduce the incidence of intracranial failure. And I wanted to also spend a few moments explaining why intracranial failure is such an important thing to suppress. So I've discussed that on the one hand, every time there's an intracranial failure, there has to be a treatment, right? And while we lean on stereotactic radiosurgery for this, sometimes it requires whole brain radiation treatment, which is associated with very high toxicity. And as I mentioned, radiosurgery is also associated with increased toxicity in the immunotherapy era. So avoiding treatment reduces the risk of treatment-related toxicity but it also as the secondary endpoint shows improved functional preservation at every brain failure could be associated with the decline in function. depending on the location and the size of that failure. So I would talk to my patients about the potential for a modality in treatment like this to help them with intracranial -- or sorry, with functional neurologic functional preservation and these study results really support that as an application. And that's how I would discuss this, I believe, with the patient.

Well, thank you very, very much for contextualizing those results now in a real life or in the clinical setting. I think that was extremely helpful. With that, I would like to pass the call back to Bill.

So Nicolas and Dr. Ramakrishna, thank you very much. We really do appreciate your insights on this patient population and the METIS trial data. We'd now like to open the floor to questions from the audience. We'll be joined by Ashley Cordova, our Chief Financial Officer; Dr. Uri Weinberg, our Chief Innovation Officer; and of course, Asaf Danziger, our CEO; and other members of our executive leadership team. With that, operator, can you please open the line?

[Operator Instructions] And our first question coming from the line of Lawrence Biegelsen with Wells Fargo.

Congratulations on another positive trial here. Can you hear me okay?

We can, Larry.

Great. So Bill or anyone on the call, can you please talk about why the time to intracranial progression did not translate into other statistically significant benefits. Was this a surprise? And has this been seen in other brain metastases trials due to non-small cell lung cancer? And did you see a dose response? And I had one follow-up.

Yes. So Larry, let me start. I'm going to turn this back to the doctors. But remind everybody that we're in this period of time between the announcement of the top line data and the presentation of the full data analysis that will come at a scientific conference. And so we are limited to the data that we have presented today in the press release. But with that, maybe I'll turn it back to Dr. Ramakrishna. I think he gave a very cogent explanation in his remarks, but maybe you can underline some of those points.

Yes. Thank you. So it's an excellent question. And as I mentioned before, in the context of selecting endpoints for brain metastases trials, one has to recognize that the impact on survival is not going to typically be detectable because of the competing risk of extracranial disease causing a death event. And the -- so I would say that the impact we would expect with this type of study for an increase in the time to intracranial progression is mainly going to be restricted to quality of life endpoints. And again, the trial is designed with a certain statistical power to detect certain assess. But I would say that this -- based on what we've released so far, that, that is a very significant a dramatic increase in time to intracranial progression which would then, as mentioned, reduce subsequent treatments, subsequent complication risks. And some of those factors are very difficult to assess in a trial like this, except with composite endpoints such as preservation of neurological function or quality of life type endpoints. And that's where you'd expect to see that benefit.

That's helpful. So Bill, it sounds like on the dose response, we'll get that at a later time. No comment on that today.

Correct. And I will also say that the full analysis is ongoing. Again, our goal was to get the top line results to our constituents as quickly as possible. And I have to say we couldn't be happier with these results. The trial was designed as was mentioned, to show a difference in the intracranial response rate. And this almost doubling is we couldn't be happier with the data.

And just one follow-up. Maybe just for the physician to flesh out a little bit more the benefit to a patient. You talked about additional -- the pushback, where did you hear that there was no benefit on the secondary endpoint statistically significant? You talked about additional therapies and toxicities with that and potential neurological benefits. How -- maybe flesh out a little bit more the conversation with a patient, how -- because the patient really doesn't understand intracranial progression, what are the benefits to the patient because this is a device that people have to wear for a significant percent of the time. what are you going to tell the patients the clinical benefits are? And how do you see adoption in this population?

Yes, yes. No, it's a great question. And these are the kind of discussions that are always very individualized. And it is, I agree, a difficult choice, and it's a commitment by patient to adopt a device like this, which needs to be worn for a large part of the time. But I would illustrate to the patient, the potential for intracranial progression and resulting deficits that could occur, I can give you an example just yesterday, for example, I had a patient that I had treated with stereotactic radiosurgery for non-small cell lung, very similar to this patient population. And she unfortunately developed intracranial progression within actually 3 months of the treatment. And the intracranial progression resulted in basically loss of strength in the right side of the body. So I mean that's a dramatic example, but these are the kind of functional consequences that an early intracranial recurrence can have. The other interesting thing to me about this is that this median time to intracranial progression is so prolonged that is really essentially approaching the median survival that you might expect any way for a relatively high risk group of patients like this. Now of course, that's something that we're starting to improve on with various systemic strategies. But -- these patients are living longer. They want to function well during that time. And so TTFields are going to be for that motivated patient that wants to have good functional preservation for the 2, 3, now maybe 3.5 years, but they might have ahead of them with improving systemic therapies.

And our next question coming from the line Jonathan Chen with Leerink.

Congrats on the results. First question, can you talk about reasons for confidence on whether hitting the primary endpoint alone is sufficient for regulatory approval? And then second question, just zooming out beyond the study. As we think about studies where tumor treating fields have succeeded or not succeeded today, what would you say are the key learnings in terms of where this device is most likely to succeed?

Yes. So I'll -- this is Bill. I'll start with the answer to the first question. From a regulatory perspective, the primary endpoint is what will determine the filing to the regulatory to the regulators. In these trials, we always try and learn as much as we can. And so we look at all sorts of secondary endpoints to try and gain information that might illuminate clinical practice, might illuminate hypotheses for subsequent studies and trials. But from a regulatory perspective, it's about the statistical design and whether or not you hit the primary endpoint. So from that regulatory perspective, I would say our confidence is quite high. And again, it's been commented on, but these are highly statistically significant data and extremely long in terms of their potential clinical impact. So that's that, if you will.

Got it. And just on the second question.

Can you repeat that for me just so I have it clearly.

Sure. So just I'm curious to understand what you think the key learnings are to date with Tumor Treating Fields in terms of where this has succeeded exceeded or not?

So we're very pleased to continue to learn about the opportunities for our platform. And to date, again, for those who are new to the story, we've had successful Phase III trials in glioblastoma in non-small cell lung cancer after platinum failure to date in brain metastases from non-small cell lung cancer and I'll underline that all 3 of these patient populations are exceptionally difficult to treat -- And in each case, it was many, many years and in some case, decades since the last improvement in benefit for these patient populations. The only Phase III trial to date that has not succeeded in the top line data was our trial in -- in ovarian cancer, after platinum failure, a very -- another very difficult-to-treat patient population. And we shared earlier this month at a presentation in -- at an international conference that what we've learned subsequently is that 1 of the chemotherapy agents that is given to these patients in later lines, doxorubicin, actually creates a change in the electrical conductivity such that the patients who didn't receive doxorubicin derived statistically significant benefit from the tumor treating fields and those that did receive it, it didn't help. And we're evaluating those findings and revising our strategy in ovarian cancer going forward. So I would say, again, we continue to have great hope that this therapy can work for patients certainly who have localized disease or regional disease. And then what we've seen in LUNAR and other clinical trials is that when the disease is systemic in combination with immunotherapy, we show a true benefit to the immunotherapy effectivity due to the immunogenic cell death that's created by the Tumor Treating Fields. So we keep learning what the best combinations are. And -- to summarize, we see application in solid tumor disease, whether it's local or whether it's systemic but with different combinations of pharmacological therapies in either case.

Got it. Congrats again.

And our next question coming from the line of Jessica Fye with JPMorgan.

This is Nick on for Jess. Congrats on the data. Maybe two from us. One, you noted that the median TTF therapy duration was 16 weeks and median usage was 67%. Can you maybe just provide a bit color on that 67% measure and kind of what factors influence usage there?

Nicolas, do you have any comments we made? Again, I will underline that the data presented today is really what we are limited to presenting and that the full analysis will come in subsequent medical conferences and papers. And maybe as I say that out loud to myself, I won't put Nicolas on the spot. I think we really are limited to the data presented in this call.

Okay. Understood. And then maybe just one on the commercial side. Kind of thinking about the addressable population here, you kind of noted in the past the brain mets from non-small cell lung cancer is a very heterogenic population. But can you maybe provide some more detail and perhaps based on the patients enrolled in this trial, which patients you perceive eligible for treatment kind of what percent that population represents relative to [indiscernible] entire brain mets from non-small cell lung cancer population and kind of how that opportunity compares to, say, GBM versus lung?

Yes. So I'll start the answer to this. We've provided the statistics on the incidents. So approximately 25% of patients diagnosed with non-small cell lung cancer will have brain mets at the time of diagnosis. And approximately 50% will develop brain mets during the course of their therapy. So it is a very large group certainly compared to GBM. That said, and I think Dr. Ramakrishna underlined this, and I may turn to him again to further explain it. This is a heterogeneous patient population, patients with different ages, different overall prognosis. And with that, we would expect, and I'm just going to repeat what was said earlier that the motivated patients who see potentially better overall prognosis but don't want to suffer neurocognitive complications or decline will be the subset patients that are most likely to receive this therapy. And maybe I've just repeated Dr. Ramakrishna what you said, but maybe I'll turn it back to you for any more comments that you may have.

No, that's perfect. That's exactly what I would think. And I think just to put things into an overall context, again, I mean brain metastases from non-small cell lung cancer are the #1 type of brain metastasis we encountered by multiple of 2.5:1. So next would come breast and then melanoma and so on. But so this group is a very large group of patients. I think it's important to point that out. And yes, it's precisely those patients who are starting off who are motivated with a reasonably good prognosis and are motivated to have a good preservation of quality of life, I think that that would be an ideal subset of patients that this might appeal to.

And our next question coming from the line of Emily Bodnar with H.C. Wainwright.

Also congrats for me on the data. A few quick ones. I was curious if you see the potentially kind of helping or advancing your non-small cell lung cancer launch which is kind of planned for next year based on your instant numbers of how of these patients might get brain mets? Like, I guess, do you see a way for this to kind of help that launch growth [indiscernible] better?

Sure. Frank Leonard is leading our efforts, commercial efforts. And Frank, maybe you can comment on the tailwind effect for non-small cell lung and maybe GBM as well.

Yes. Thank you, Bill. What I would say is that, I think, number one, from a scientific standpoint, Metis confirms TTFields ability to impact cancer of the brain and also -- cancers within the brain and also non-small cell lung cancer And so what we see coming out of this trial is that we've underlined the ability of TTFields to impact a meaningful clinical endpoint without adding systemic toxicity. And I think for current users the doctors who are treating glioblastoma today and are supportive of the therapy. they can look at that combination of an effect within the CNS system along with an impact on a new tumor type as reinforcing the existing confidence. And I think for skeptics today within the Doctors Treating glioblastoma, this is just yet another compelling clinical case for using Tumor Treating Fields. And it's also one of the first times we've shown Tumor Treating Fields really against best supportive care. And so it's really a clean clinical look at the effect of Tumor Treating Fields against the target. With respect to the lung launch, we think, generally speaking, this is positive data that data that will be perceived positively by doctors who are prescribing to treat the primary tumors in non-small cell lung cancer. And I think in the coming quarters, we'll talk a little bit more about how we intend to bring this indication to market through the existing capabilities that we've built both on delivering tumor treating fields to doctors treating GBM as well as the emerging capabilities that we're building for -- to deliver the therapy to doctors who are treating non-small cell lung cancer.

That's helpful. And then just one more question. If you can comment on kind of subgroup analysis you're currently conducting and any time periods for guidance on when we may see additional data this year or PMA submission?

Yes. Again, we are -- we always take these Phase III data sets and try and glean all the information that's clinically important and scientifically important. And I'll highlight the subsequent analysis in our INNOVATE trial in ovarian cancer, where we learned the very important fact that we didn't know previously that doxorubicin interferes with the effect of Tumor Treating Fields. So we'll be looking at a lot of different things here. And we will be -- and I'm sure that there will be presentations and publications in many conferences to come. We're, of course, focused on the first podium presentation at the first appropriate scientific conference. We don't know what that will be yet. And getting the key data and key analyses in peer review as quickly as possible. So those will be the initial [indiscernible], and I would expect that both of those events will happen this year.

And our next question coming from the line of Vijay Kumar with Evercore ISI.

Congrats on the headline results here. I had a couple for, I guess, maybe Dr. Ramakrishna. I think you mentioned the clinical benefit is perhaps a delay in recurrence. I just wanted to clarify, did this trial measure a delay in recurrence. When you say there was a delay in progression, is that the same as recurrence or those 2 terms different?

So I think it's a great question because when we discuss intracranial control, we're discussing both the control of the tumors that were treated as well as the incidence of new brain metastases, something we would call distant brain failure. And we've developed some standardized metric systems as a field to assess intracranial control for the purpose of clinical trials with the 1 that we've utilized, which is [indiscernible] so that is the context in which we've performed this sort of intracranial progression analysis. But Nicolas, if you'd like to address that as well.

Yes. I think you perfectly answered. I wouldn't really need to add anything I think.

Understood. And maybe one more for you, Dr. Ramakrishna. On the -- I guess, if there is a delay in progression, one would have thought that benefit -- clinical benefit in terms of neurological functions. So I think one of the examples you gave was perhaps if there is a recurrence, you could perhaps proven palsy or some sort of neurological benefit, right? Were those measured in this trial because I think the second endpoints that did not meet the neurological benefits?

Well, on the top line results now and the delayed time to deterioration of global health status was improved. So that is one measure. Some of these secondary endpoints, I think are going to -- are difficult sometimes to design a trial forward or designed, obviously, for the primary endpoint. But I think that there's a lot of additional analysis that needs to occur. I think that we will uncover additional benefits. And I was giving examples of what I think this would mean clinically based on that primary endpoint improvement -- that, one, it means that you would need less intervention, less radiosurgery, that's whole brain. That's what I would expect in a scenario like that. And that also the complication rates associated with -- so less neurological failure and less complication rates associated with every -- but again, these require some -- that requires a larger population at times to detect those effects. But that's what I think is the promise of this type of approach.

And Vijay, I'll just emphasize. The METIS trial was designed in a way that's very consistent. I'm not sure this has been said explicitly, but consistent with the way brain metastases trials are designed. So this was not a new design per se. This was consistent with the way these trials are designed and the primary end point is consistent with the way trials in this -- of this type are designed. I've remarked on other calls that this is the one trial in our pipeline that does not focus on overall survival, all the others do and are designed to show an overall survival benefit. Again, here, we're treating metastatic disease. And we designed the trial to study the time to intracranial progression. We showed a really phenomenal extension that's highly significant. We'll study all the secondary endpoints, of course, as I said, to glean practice helping observations as well as scientific observations. But the goal of this trial was met and it was met quite resoundingly.

Understood, Bill. And maybe one for you, Bill. Was the study powered to show stat significance on the secondary endpoints? And I think the enrollment period was pretty long. Why was it so -- why did it take so long to enroll patients and perhaps [indiscernible] some relevance to the real world population?

Yes. So I will leave the questions to the statistical design to later, Vijay. But these trials enrolled in -- we have trials that enrolled quickly and trials that take sometimes longer to enroll, they depend on the number of sites that are open and lots of other factors. So we don't draw any conclusions one way or the other from the enrollment patterns. Ultimately, we judge the potential based on the data. And as been remarked here this morning, we couldn't be more pleased with the really long lengths of improvement and the highly statistically significant nature of the results in a trial that is in a very difficult-to-treat heterogeneous patient population.

I'm showing no further questions in the queue at this time. I will now turn the call back over to Mr. Bill Doyle for any closing remarks.

So simply, let me thank everyone for joining us this morning. As I've said a few times, this is one of those very happy days in a company like NovoCure. We've been working on this platform for 24 years. And the days when we can present phase III data in a trial that took years to design, perform and then follow up, we just couldn't be happier. We are thrilled that we've been able to extend the time of endocranial progression and has been discussed this morning could potentially change the way that brain mets are treated in the future. We look forward to sharing the full published data in the future. We look forward to bringing these data to the regulators, and we look forward to updating you further as we make progress on all these fronts. If you have any additional questions, of course, our IR team is going to be available, don't hesitate to reach out to them. And I guess the next time, we'll all be together as at our earnings call, and we will see you then. Thanks to everyone.

Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation, and you may now disconnect.