Good day, and thank you for standing by. Welcome to the METIS conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automatic message advising that your hand is raised. 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 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 and Pediatric Neuroradiation Oncology and Proton Therapy Programs at the Orlando Health Cancer 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. 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, and trials like METIS are one of the reasons I was so keen in joining 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 four patients in the U.S. alone each year. This number is also on the rise as advancements in the systemic treatment of the primary tumor can extend lives, but are limited in their ability to halt metastatic spread.
Approximately 25% of patients with NSCLC have brain metastasis at diagnosis, and the lifetime risk of a patient developing metastasis in the brain is approximately 50%. Once brain metastases are found, the prognosis is quite poor. Further impacting this dire diagnosis is the serious impact brain metastasis can have on a patient's quality of life, which can affect the patient's motor 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 two avenues for treatment: stereotactic radiosurgery and whole brain radiation. Stereotactic radiosurgery, or SRS, is a first line of defense in which precise dosage of radiation is focused to remove metastasis. SRS is effective, but does little to control formation or spread of new metastasis 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 one 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 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. Consistent with previous studies, TTFields therapy was well tolerated. Preliminary analysis of key secondary endpoints, specifically time 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.
Full analysis of these data are ongoing, and we intend to share the full data set at an upcoming scientific congress, followed by 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 Neuroradiation 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 the Director of Adult Neuroradiation Oncology and Pediatric Neuroradiation 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 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 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 incidence in these patients.
Now, over the last decade, we've become increasingly reliant on a modality we call stereotactic radiosurgery to treat brain metastasis 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 of 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.
These challenges and complications have actually increased over the last five to seven 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 newly 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.
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. In fact, the secondary endpoint that was analyzed on preservation of function or deterioration-free survival supports that notion. 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 one 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%-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 PFS. Now, help us to understand if you had to describe one typical patient, who would benefit from these results today?
It's a great question, Nicolas, and the challenge of treating this patient population extends from the brain to the body. The patients without driver mutations with non-small cell lung cancer are an extremely challenging set of patients to control disease in. Extracranial disease control in these patients is typically not as good as those patients who do have these driver mutations. When extracranial disease is not controlled well, then there tends to be this constant risk of seeding the brain with new metastases. So when a patient presents with brain metastatic disease in the setting of metastatic, you know, 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.
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, improves functional preservation, because every brain failure could be associated with a decline in function, depending on the location and the size of that failure.
So I would talk to my patient about the potential for a modality and treatment like this to help them with intracranial... Or sorry, with functional, neurologic functional preservation. And these study results really support that as a, an application. And that, and that's how I would discuss this, I believe, with the patient.
...Well, thank you very, very much for, you know, contextualizing those results now in, 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, Nicholas and, Dr. Ramakrishna, thank you very much. We really do appreciate your insights on this patient population and the METIS trial data. Would 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?
Certainly. Please, ladies and gentlemen, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, simply press star one one again. Please stand by while we compile the Q&A roster. Our first question coming from the line of Lawrence Biegelsen with Wells Fargo. Your line is open.
Good morning. Thanks for taking the questions, and congratulations on another positive trial here. Can you hear me okay?
We can, Larry. Good morning.
Great. So Bill, or you know, 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.
Yeah. So, Larry, let me start. I'm gonna 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, you know, 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 so I would say that the impact we would expect that 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, you know, the trial is designed with a certain statistical power to detect certain effects.
But I would say that this, based on what we've released so far, that that is a very significant and 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, 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, you know, 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, you know, this almost doubling is. We couldn't be happier with the data.
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, you know, the pushback. We're going to hear that there was no benefit on the secondary endpoint, statistically significant. You talked about, you know, additional therapies and toxicities with that, and potential neurological benefits. How—maybe flesh out a little bit more the conversation with a patient. How, you know—
Yes.
Because a patient really doesn't understand intracranial progression. What are the benefits to the patient? Because this, you know, this is a device that people have to wear for, you know, a significant percent of the time. What are you going to tell a patient the clinical benefits are? And how do you see adoption in this population? Thank you.
Yes, yes. No, it's a great question, and, you know, these are the kind of discussions that are always, you know, very individualized. And it is, I agree, a difficult choice, and it's a commitment by a patient to adopt a device like this, you know, which needs to be worn for a large part of the time. But I would illustrate to the patient, you know, the potential for intracranial progression, and the 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.
She unfortunately developed intracranial progression within actually three 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. You know, the other interesting thing to me about this is that this median time to intracranial progression is so prolonged that it's really essentially approaching, you know, the median survival that you might expect anyway 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, you know, these patients are living longer, they want to function well during that time.
And so TT Fields are going to be for that motivated patient that wants to have good functional preservation, you know, for two, three, you know, now maybe 3.5 years, but they might have ahead of them, you know, with improving systemic therapies.
All right. Thank you so much, and congratulations again.
Thanks, Larry.
Thank you. Our next question coming from the line of Jonathan Chang with Leerink. Your line is open.
Hi, guys. Congrats on the results, and thanks for taking my questions. 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 this study, as we think about studies where tumor treating fields have succeeded or not succeeded to date, what would you say are the key learnings in terms of where this device is most likely to succeed? Thank you.
Yeah. 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 regulator, 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, so that you know, that's that, if you will.
Got it. Thank you. 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?
Ah.
With Tumor Treating Fields in terms of where this has succeeded 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, today, in brain metastases from non-small cell lung cancer. And I'll underline that all three of these patient populations are exceptionally difficult to treat, and in each case, it was many, many years, and in some cases, 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 ovarian cancer after platinum failure, a very... another very difficult-to-treat patient population.
We shared, earlier this month, at a presentation in, at an international conference, that what we've learned subsequently is that one 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. 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 field. So we keep learning what the best combinations are and we you know 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 thanks for taking my questions.
Thank you. And our next question coming from the line of Jessica Fye with JP Morgan. Your line is open.
Hey, good morning. This is Nick on for Jess. Congrats on the data, and thanks for taking our questions. 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 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, I won't put Nicolas on the spot. I think, 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 that brain mets from non-small cell lung cancer is a very heterogeneous 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 % that population represents relative to the entire brain mets from non-small cell lung cancer population, and kind of how that opportunity compares to, say, GBM or versus lung?
Yeah. So I'll start the answer to this. We've provided the statistics on the incidence. 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 prognoses.
And, with, with that, you know, we would expect, and I'm just going to repeat what was said earlier, that the, that the motivated patients, who, you know, see potentially better overall prognoses but don't want to suffer neurocognitive, complications or, or decline, will be the subset of patients, that are most likely to receive this therapy. And, and maybe I've just repeated, Dr. Ramakrishna, what, what you said, but maybe I'll, I'll turn it back to you for any more, comments that you may have.
Oh, oh, no, that's perfect. You know, 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 number one type of brain metastasis we encounter by a multiple of 2.5 to one. So, you know, 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, you know, who are starting off, you know, who are motivated with a reasonably good prognosis and are motivated to have, you know, a good preservation of quality of life.
I think that would be an ideal subset of patients that this might appeal to.
Great. Thanks for taking my questions.
Thank you. One moment for our next question. Our next question coming from the line of Emily Bodnar with H.C. Wainwright. The line is open.
Hi, good morning. Thanks for taking the questions, and also congrats from me on the data. Two quick ones. I was curious if you see this data set potentially kind of helping or advancing your non-small cell lung cancer launch, which is kind of planned for next year based on, you know, your, your incidence numbers of how almost 50% of these patients might get brain mets. Like, I guess, do you see a way for this to kind of help that launch, growth go 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. You know, what I would say is that I think number one, from a scientific standpoint, METIS confirms TTFields' ability to impact cancers of the brain and also, or cancers within the brain, and also, non-small cell lung cancer cell types. And, you know, 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, for the doctors who are treating glioblastoma today and are, you know, 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 their the existing confidence.
And I think for, you know, for skeptics today, within the doctors treating glioblastoma, this is just, you know, 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, you know, we think generally speaking, this is, you know, positive data that will be perceived positively by doctors who are prescribing to treat the primary tumors in non-small cell lung cancer.
I think in the coming, you know, in the coming quarters, we'll talk a little bit more about how we, you know, how we intend to bring this indication to market through the, 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.
Okay, thank you. That's helpful. And then just one more question, if you can comment on what 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? Thank you.
Yeah. Again, we always take these phase III data sets, and try and glean all the information that's clinically important and scientifically important. And, you know, 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, you know, 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. Those will be the initial foci, and you know, I would expect that both of those events will happen this year.
Okay, thank you. Excellent.
Thank you. And our next question coming from the line of Vijay Kumar with Evercore ISI. Your line is open.
Hey, guys. Thanks for taking my question, and congrats on the headline results here. I had a couple for I guess maybe Dr. Ramakrishna. I think you mentioned that the clinical benefit is perhaps a delay in recurrence. I just want 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 are those two 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, you know, 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 one that we've utilized, which is RANO BM. 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.
Yeah, I think, I think you, you perfectly answered. I, I wouldn't really need to add anything, I think.
Understood. And maybe one more for you, Dr. Ramakrishna. I guess if there is a delay in progression, one would adopt that there is a 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 you know prevent palsy or some sort of neurological benefit, right? Were those measured in this trial? Because I think the secondary endpoint said did not meet the neurological benefits.
... Well, you know, on the top line results now and the delayed time to deterioration, the global health status was improved. So that is one measure. You know, these some of these secondary endpoints, I think are gonna re- are, you know, difficult sometimes to design a trial for. Were 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, less whole brain.
That's what I would expect in a scenario like that, and that also, the complication rates associated with less neurological failure and less complication rates associated with the treatment. But again, these require sometimes 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, you know, a new design per se. This was consistent with the way these trials are designed, and the primary endpoint 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 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 a trial to study the time to intracranial progression.
We showed a, you know, really phenomenal extension that's highly significant. We'll study all the secondary endpoints, of course, as I said, to glean, you know, practical observations as well as scientific observations. But, you know, 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 statistical 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 thoughts on relevance to a real-world population.
Yeah, so, you know, I will leave the questions to the statistical design to later, Vijay. But, you know, these trials enroll in... You know, we have trials that enroll quickly and trials that, you know, 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, you know, we judge the potential based on the data. And, you know, it's 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, you know, is in a very difficult-to-treat heterogeneous patient population.
Understood. Thanks, guys.
Thank you. Now 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, you know, simply let me thank everyone for joining us this morning. As I've said a few times, you know, this, 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, you know, we just couldn't be happier. We are thrilled that we've been able to extend the time of intracranial 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 gonna be available. Don't hesitate to reach out to them. And I guess the next time we'll all be together is at our earnings call, and we will see you then. Thanks to everyone.
Ladies and gentlemen, that does end our conference for today. Thank you for your participation, and you may now disconnect.