Iovance Biotherapeutics, Inc. (IOVA) Earnings Call Transcript & Summary

Thank you for standing by, and welcome to the Iovance Biotherapeutics update call. [Operator Instructions] Please be advised that today's conference may be recorded. [Operator Instructions] I would now like to hand the conference over to your host, Sara Pellegrino. Please go ahead.

Thank you. Good afternoon, and thank you for joining our conference call to discuss the initial clinical data for our TIL cell therapy LN-145 in metastatic non-small cell lung cancer, or NSCLC. For today's agenda, our Interim President and CEO, Fred Vogt, will do a brief introduction; Dr. Friedrich Finckenstein, our Chief Medical Officer; and Dr. Madan Jagasia, our Senior Vice President, Medical Affairs, will then highlight the clinical data, and we will hold a question-and-answer session. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's clinical results, goals, business focus, business plans, clinical trials, cash position and expense guidance and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call, and we undertake no obligation to publicly update any forward-looking statements. With that, I will turn the call over to Fred.

Thank you, Sara, and good afternoon, everyone. I'm pleased to host today's call to review what we believe are very exciting initial clinical data for TIL therapy in non-small cell lung cancer, which is the first clinical data for Iovance in this indication and represent the fourth solid tumor indication where our TIL platform has demonstrated significant potential to address unmet medical need for cancer patients. We are releasing this data right now because we are excited about the potential for TIL in lung cancer. And we recently did a data cut that gives us confidence in our development strategy for LN-145 and multiple cohorts in the basket study IOV-COM-202 as well as in our registration supporting study, IOV-LUN-202. With $610 million in cash on the balance sheet as of March 31, this data release is not related to any imminent financing plans, and we are well capitalized to develop our pipeline and prepare for commercialization. With that, turning back to the data, I'm pleased to introduce Friedrich and Madan.

Thank you, Fred. Today, I will review clinical data for our TIL therapy LN-145 in patients with metastatic non-small cell lung cancer, or NSCLC, who enrolled in cohort 3B of the ongoing basket study IOV-COM-202. Cohort 3B enrolled patients that have progressed on prior immune checkpoint inhibitor, or ICI therapy, including patients with oncogene-driven tumors who received prior tyrosine kinase inhibitor therapy. While we are saving more detailed baseline demographics for a future medical meeting, it is worth noting that 24 of the 28 patients or 85.7%, including all the responders, have received 2 or more prior lines of systemic therapies. If they had an oncogene driver mutation, they had also received at least 1 targeted therapy. There is a significant unmet need to increase overall response rate or ORR and prolonged survival in this difficult-to-treat non-small cell lung cancer population. So we were very pleased to see an ORR of 21.4%, including 1 confirmed complete response and 5 confirmed partial responses and 64.3% disease control rate. Historically, ORRs of approximately 20% were reported with ICI as second-line therapy and ICI-naive patients who progressed on frontline chemotherapy. So we are pleased to see a comparable ORR in sicker patients in cohort 3B who have all received prior anti-PD-1 therapy. In addition, median duration of response has not been reached at 8.2 months of median study follow-up. In terms of safety, the safety profile was consistent with treatment emergent adverse events that were consistent with underlying disease and known adverse event profiles for non-myeloablative lymphodepletion chemotherapy and interleukin 2. Turning to the next slide. We show the waterfall plot for all 24 evaluable patients as of a very recent data cut on June 24. Patient 2 had a complete response, or CR, based on a negative FDG-PET scan by investigator. This patient had 2 target lesions going into treatment. One target lesion had 100% resolution. Another target lesion is small and remained identifiable on posttreatment CT scans. Following multiple negative PET scans several months apart, with prolonged follow-up and lack of subsequent therapy, this patient has met criteria for a confirmed complete metabolic response and thus also CR in accordance with RECIST 1.1 criteria. The 5 patients in blue showing partial responses had at least a 30% reduction in target tumor burden and at least 2 assessments and thus are confirmed partial responders per RECIST 1.1. Then we have 12 patients with stable disease and 6 with progressive disease as best overall response. Today, we are focused on characterizing the responders as shown on the next slide. The swimlane plot shows time to response for our 6 confirmed responders. As shown on the left, we had 2 responders with PD-L1 negative status, and 4 responders with PD-L1 positive status. This distribution of PD-L1 status is reflective of the non-small cell lung cancer population in which about 1/3 of patients are PD-L1 negative and challenging to address with current standard of care immunotherapy. So we are happy to see responses with TIL regardless of PD-L1 status, which is consistent with what we have seen in other solid tumor indications as well. Overall, we are very pleased to see that these data confirm what we saw as promising results from the H. Lee Moffitt Center at AACR last year, and gives us further confidence in advancing Iovance TIL in non-small cell lung cancer. A lot of people are asking for the context of our results in the basket study to the Moffitt data. So we'll ask Madan to present a brief summary of the Moffitt study. Madan?

I would like to highlight the proof of concept for TIL therapy in non-small cell lung cancer patients who are naive to anti-PD-1 and which gave us confidence in moving ahead with our own Iovance TIL lung cancer program. This study was a single-center academic study with a very different patient population and study design. So it's not a real comparison, but a proof of concept. Moffitt enrolled patients much earlier in the disease course as compared to cohort 3B as they had received only 0:1 prior systemic therapy and all patients were naive to anti-PD-1 or anti-PD-L1 therapy. The tumor samples were resected and harvested using a tumor banking model, which has many disadvantages, including lack of commercial viability and the TIL repertoire in the tumor microenvironment at harvest may defer from the TIL repertoire in the patient at the time of progression. All patients began with nivolumab treatment and patients who subsequently progressed on nivolumab received a combination regimen of TIL followed by IL-2 and then subsequent continuous treatment with single-agent nivolumab. Among the 12 evaluable patients, the ORR was 25%, including 2 complete responses and 1 partial response for RECIST 1.1. Again, this is a good proof-of-concept study in the anti-PD-1 naive patients with a combination regimen, and we are exploring combination regimens in our basket study in 2 additional cohorts. Cohort 3A is investigating TIL in combination with pembrolizumab. In addition, our cohort 3C, which we recently opened at the beginning of 2021 is evaluating TIL plus ipi/nivo. The next slide, our registration supporting study IOV-LUN-202, which dosed the first patient recently, we are investigating LN-145 in recurrent or metastatic non-small cell lung cancer patients without driver mutation who previously received a single line of approved systemic therapy with a checkpoint inhibitor and chemotherapy. Within this patient population with significant unmet need, we will look at 4 different cohorts. Cohort 1 would include patients whose tumors at baseline at the time of diagnosis did not express PD-L1 with a TPS score of less than 1%. Cohort 2 will have tumors that express PD-L1 with a TPS score greater than 1%. Cohort 3 patients also will have TPS scores less than 1% in which we will grow TIL from core biopsies to infuse back to the patient. And finally, cohort 4 will offer retreatment for patients who progress in cohorts 1 to 3. The cohorts in LUN-202 study are distinct from the 2 cohorts in our ongoing IOV-COM-202 basket study in patient populations that they enroll. The primary efficacy endpoint will be objective response rate, or ORR, assessed by Independent Review Committee or IRC. With that, I will hand it over to Fred to discuss the milestones.

Thank you, Madan, and thank you, Friedrich, for your updates. I'll just briefly touch on some of our milestones in non-small cell lung quickly, and then we'll move to questions. Two milestones that we've achieved recently. Obviously, cohort 3B, which we reported on today is a big milestone for us, and we fully enrolled that cohort. We've also just announced today that the first patient has been dosed in the registration supporting study IOV-LUN-202. Two upcoming milestones of importance in NSCLC for us are additional cohort 3b data at a medical meeting, hopefully, in the second half of this year, and activation of additional sites and enrollment in IOV-LUN-202 as well as the other cohorts that we've got open. Or as you heard, we have 7 total cohorts open of lung studies counting the retreatment cohort, LUN-202. I'd now like to hand over to the operator to begin the Q&A session.

[Operator Instructions] Our first question comes from the line of Michael Yee of Jefferies.

Congrats on this data. Two questions. One was your thoughts about the LUN-202 study in the context of comments around the potential pivotal nature of that or registrational nature. Can you just comment on how you think about what the bar is? Or why you think that could be pivotal as other companies, I think, generally are trying to run randomized studies? So maybe just comment on the context of LUN-202 in the context of this data presented today. And then one detailed question is just can you comment on the severity of these patients, your prognostic factors such as LDH, et cetera? Maybe just comment about that.

Michael, I want to -- Friedrich, would you be able to take those questions?

Sure. Happy to. Thank you for the question. So as Madan described, the LUN-202 study is a study that will generate response rate data that are IRC-reviewed in 2 cohorts separated by PD-1 status, PD-L1 negative or PD-L1 positive, which gives us some flexibility in exploring and determining the activity and the benefit/risk separately, but also these are similar to pool the data and look at this together in the larger sample set. The bar that we are looking at really is the currently available therapy for these patients, which is as it was in the initial approvals of checkpoint inhibitors in second-line monotherapy chemotherapy. So docetaxel is probably the best bar here, with response rates below 10% and short durability of responses. We believe that single-arm data may be a potential route for a registration strategy, given the fact that this is a novel therapy. The TIL regimen is a onetime therapy. So we are, as you all know, administering this only one time with no maintenance therapy. And obviously, depending on the degree of benefit and difference in response rates over docetaxel. The question about the prognostic factors. Really, what we are planning on doing -- and since this involves kind of a summary of the larger context here, business data and detail that we would be presenting at the future upcoming medical conference.

Our next question comes from Mark Breidenbach of Oppenheimer.

This is Matt on for Mark. Just wanted to touch on the topic of biopsy banking. I think as you mentioned, the Moffitt trial was banking the biopsies before PD-1 exposure, whereas your biopsy right before TIL infusion, so post PD-1. Do you think we have enough data now to really determine that banking biopsies is not the optimal way to go?

Why don't I -- I can answer that initially, Mark, but then I'll ask Madan and Friedrich to chime in if they have any additional thoughts on this. Right now, there's preclinical information -- preclinical data out there that suggests that we are -- that the tumor microenvironment and the TIL repertoire changes when you administer checkpoints, right? So that's the key aspect of that. The banking model is also -- you have to remember, is not really commercially viable from our perspective, at least today, because of the fact that you have to find a way to somehow reimburse and pay for banking treatment ahead of some other line of therapy long before you ever had TIL therapy. So again, I'd like to just reemphasize those 2 points as being pretty critical. While it's great in an IST-type setting, an investigator sponsored trial setting, or an academia -- MD Anderson does this as well, it's difficult to see that in the commercial landscape. Madan and Friedrich, do you want to add anything that you have from the scientific side?

This is Madan. Yes, I echo Fred's comments over there. I think this is not feasible in the commercial setting. And also, if you look at the other tumor types where Iovance has experience, we have successfully harvested tumor specimen grown until after prior PD-1 exposure. And also, biologically, it is possible that the TIL repertoire that the patient had at initial therapy and a subsequent progression is significantly different. So we feel that harvesting the TILs at the time most proximal to the administration TIL biologically makes more sense.

That makes sense. And I had a follow-up on LUN-202, if you don't mind. Can you just jog our memory if you're going to be excluding patients with oncogenic drivers? So mutations like EGFR RET MET? And maybe given the strong data that we've seen today, maybe just explain what would be the rationale behind excluding those patients? .

From -- I assume you mean from IOV -- from LUN-202, right?

Correct. Correct.

Yes. Friedrich, do you want to explain the enrollment criteria?

Yes, absolutely. So what we're going for here really is patients who has received a single line of prior systemic therapy for non-small cell lung cancer with chemo and ICI combination. That is usually a standard of care that is not used in patients with driver mutations. -- because there's an understanding that the addition of checkpoint inhibitor in that population would not necessarily generate benefit in these patients. So in order to, number one, keep the cohort homogeneous, which is important if you're making a statement around -- or if you're trying to generate a data set supporting potential registrational efforts, but also in order to reflect standard of care, we are excluding these in alignment with label for the use of check inhibitors in first-line non-small cell lung cancer.

Our next question comes from Mara Goldstein of Mizuho.

Just a clarification on the data set and then a question on the overall study. The patients in the data that you released had at least 2 lines of therapy. How many had more than 2 lines of therapy, if you don't mind me asking, if you know the answer to that? And then the second question, I just had is that the LUN-202 study, right, will include individuals who had disease progression on prior checkpoint plus chemo. Is that described as checkpoint plus chemo or checkpoint follow -- like a sequential treatment as opposed to combination, and do you think that will matter?

Yes. Why don't I take the first one, and Friedrich, you can take the second one? So on the first one, Mara, we're trying to save some of this stuff for a scientific conference later and that's -- our intention is to present more detail on the prior lines of therapy at that conference. We've disclosed what we have in that, what you've seen already today is that 24, 23, including all the responders have received at least 2, not more prior lines of therapy all just PD-1, PD-L1 and all responders prior chemo. Other than that, we still are analyzing and we still have to look at that for future medical conference. Friedrich, do you want to talk a little bit more about sequential versus the same time for CPI plus chemo, LUN-202 study? Everybody go on mute please.

Sure . Absolutely. Thanks, Fred. So we're requiring the [ check inhibitor ] and the chemotherapy to have been given as the combination therapy as part of a single line of prior therapy. The rationale for doing that is, number one, that's really how the majority of patients is receiving this therapy now. And second, what we are trying to accomplish is to keep the number of prior therapies and the time on systemic therapies for metastatic disease somewhat shorter because we believe that patients in earlier settings with less pretreatment -- less time on pretreatment may fare better on TIL therapy.

Our next question comes from Peter Lawson of Barclays.

Thanks for the update today. Just as we think about the next update, kind of will we get further data, more data or just more detail around the existing patients that we've seen?

Peter, you mean the medical conference where we would potentially present the additional data on cohort 3B or more generally?

On the 3B.

We don't know for sure, but if that conference -- the timing permits, it's possible we could put more data in there. It depends on when we cut the data and the timing for the conference and everything else. So that one, all I can say there is stay tuned. And we'll go to that...

But that's where we get lines of therapy and spider plots, et cetera?

Yes. Well, our intention is to submit additional -- to have a full package for a medical conference later this year. And typically, we'd have that kind of thing in that sort of presentation.

Okay. And then you had a -- for the patient that was a CR, would that have been a CR under RECIST? And I guess why wasn't that a 100% reduction when you look at the waterfall chart?

Friedrich, do you want to take on the PET question there?

Yes. Yes, happy to. So why you're not seeing a reduction to 100% on the waterfall is because there was a remaining math on the CT scan, so that stayed remaining for a while, which triggers the PI to look at whether that math is actually representing tumor or potentially scar or fibrous tissue, which is sometimes what you see with immunotherapy. The way to do that is to do an FDG-PET scan. So you're looking at whether that is actually high metabolic activity with high glucose uptake that would indicate presence of tumor cells in this. This particular math did not enrich, did not uptake labeled glucose, indicating that it's likely not tumor. And in a situation like that, the RECIST 1.1 criteria, that data and that information to support a CR assessment is part of that because really, it's an assessment as non-tumor. And then still have something -- you still measure something on the CT scan, and that's what you're seeing on the waterfall plot.

Got you. And then I guess on the other side of things, you had a couple of patients with 3D PRs. What kind of kept them away from being called CRs?

Yes. So for what you're seeing on these -- on the labels on the waterfall plot are really confirmed response assessment. So all the PRs and all the CRs that you're seeing now are confirmed assessments, which requires confirmation in at least 2 subsequent assessments or CT scans or FDG-PET scans in the case of the CR patients. These are patients where an initial response was not confirmed by subsequent CT scans. So you're seeing the best single time points and then the color code is giving information on the BOR assessment by RECIST, which requires confirmation.

Got you. And with these on like PET scan showing activity? So there was residual tumor there?

In a situation like that, there's really no good clinical reason to do a PET scan. This -- the PET scan is really something that is done by a PI in the right clinical context, which oftentimes is when you have a tumor that, over a number of assessments, doesn't change in size.

Our next question comes from Asthika Goonewardene of Truist Securities.

Maybe one to Friedrich. I'm going to ask you a baseline question, but I'll ask it qualitatively. So hopefully you can give us some indication, Friedrich. Did you have any patients with primary progressive disease or best responsive progressive disease to prior PD-1? And if so, did any of them have a PR? And then I have a follow-up.

Thanks, Asthika This is a good example for the type of data that we want to -- that we really want to show as part of the description of the entire population as part of a future medical conference.

Okay. And then maybe, Friedrich, could you tell us anything about the patient that had the initial response and then progressed? Was that maybe a new lesion or was the actual target lesion grow?

So I believe this was a new lesion.

Our next question comes from Boris Peaker of Cowen. We'll go to the next question that comes from Madhu Kumar of Goldman Sachs.

This is Rob on for Madhu. I was just going to ask a question, do you envision using LN-145 as a monotherapy immediately after PD-1 or PD-1 plus platinum chemo regimens? Or after these regimens, plus taxane chemo?

No. We're focused right now on monotherapies, and that's what we're looking at in the LUN-202 study, for example, cohorts 1, 2, and 3. And as we're talking about today, with respect to Cohort 3B. Not in combination with that -- well, it's something you could explore, but it's not something we're currently working on with these studies.

Okay. And were there any unconfirmed responses among the remaining 28 patients?

The data set here is fully RECIST. So it's -- everything is confirmed. Friedrich, do you want to add to that?

I think that's the correct response.

Yes. We don't -- we're only reporting confirmed PRs. So...

Okay. And then one last one. Do you think between the Moffitt EGFR responder plus your data, you could support the use of LN-145 monotherapy in the post-TKI setting in RTK mutant non-small cell lung cancer?

Certainly, it's promising. It's an example of the power of TIL therapy. I think it needs to be further explored. It's something that we're certainly very interested in. You can see the focus value on 202 right now is on patients who got actual driver mutations. Friedrich or Madan, do you want to add anything to that?

No, I would agree with that. Go ahead, Friedrich.

Yes. And I think I can share that we have studies that are enrolling patients who have failed TKI therapy and then go into TIL-containing regimens as part of our ongoing non-small cell lung cancer study. So we are interested in exploring and generating data in that setting.

Right in COM-202.

That's correct. It's on 3A.

Our next question comes from Ben Burnett of Stifel.

I just wanted to ask a clarifying question about -- I think this is something that's come up. But on the waterfall plot, 2 patients looks like they had a reduction in tumor size beyond that 30% threshold needed to codify a PR. Is the reason they're not codified as a PR and codified a stable disease because they were unconfirmed and they only have 1 scan?

Friedrich, do you want to take that one?

Yes, that's correct. RECIST is reporting patients with an initial response as a single assessment that is not confirmed in follow-up assessments as stable disease. And that's what they're using as the conventional way they're following.

Okay. So the subsequent follow-up scan showed not a response, and that's why they're deemed stable disease, not because there just hasn't yet been a follow-up scan?

That's correct. Yes.

Got it. Okay. And then I just want to ask, the other question is, so how did the number of IL-2 doses used here compare to, like, say, melanoma, for example?

Are you asking the -- why don't you take it, just bear in mind that some of this might be on our future medical [indiscernible] presentation.

Exactly. That would have been my answer.

But if you want to ask -- the paradigm is the same, if that helps you at all. For some reason IL-2 is 600,000 IU same approach.

Okay. And then maybe just a last question. Are you still enrolling patients in this cohort?

In 3B?

In 3B.

Yes, I mentioned, though, one of the milestones. 3B is fully enrolled.

Our next question comes from Ren Benjamin of JMP Securities.

Congrats on the data. As I think about PR to CR conversions or even SD to PR conversions from prior studies like melanoma and cervical, is there any reason a non-small cell lung cancer indication might not behave in a similar way? Or should we be anticipating or thinking about the potential for other conversions to take place, given the follow-up?

Friedrich or Madan, maybe it's worth just reviewing some of the other -- the experience we've had in other therapy -- other indications, and then try to provide some color there.

Sure, I think the question is about previous data that we reported where you saw conversions from stable disease to PR or from initial PR to then a later CR. I think you see examples for that happening in the study as well. So on Slide 5, which is the main part. Patient 17 developed a PR at an assessment about 5 to 6 months in. That patient would have been stable disease at the assessments prior to that. So there, you have an example for stable disease to PR conversion, and then patient 2 had an initial PR and then converted to a CR. So I think you'll see some of the things happening here, obviously. More follow-up though will give us a better idea of what's happening in the patients that are currently ongoing with the PR.

Got it. And then from the safety profile, I know that it's supposed to be similar to other studies, but the background here is different, right, different chemo regimens and the like. Is there anything different at all from the safety perspective that's worth noting? Or is it pretty much all the typical grade 1, 2, 3s that we've seen before occur here as well?

Friedrich, you want to -- well, let me preface it by saying, obviously, this is -- a lot of this will be in the future medical conference presentation, so just bear that in mind. But Friedrich, please feel free to comment.

Yes. I mean at a high level, again, keep in mind, the TIL regimen consists of the non-myeloablative lymph depleting chemotherapy, the TIL administration and the post TIL Interleukin-2, how we are usually looking at the safety profile and what we would be presenting similar to how we have presented this in the previous presentations is look at the common treatment-emergent adverse events and then basically go from top down, right, and then we will be able to compare kind of side by side what makes the cut into the more common group. So I think that's the type of data that we would be presenting. The -- and that is the basis for what we've said in other settings as well, and this one is really the consistency of those adverse events with either the chemotherapy or IL-2 therapy.

Got it. And just one, I guess, 2 real quick ones for me. Fred, can you remind us -- I think you mentioned this in the prepared remarks, but what triggered the reporting of the data now versus, let's say, closer to an abstract being accepted at a medical conference? And then also the reporting of the cadence of data, you said an update for 3B, right? This is fully enrolled. What's happening with 3A?

Sure. So remember, we are going to -- our intention is to present this at a medical conference. What we tried to do here, in the spirit of communicating with the investment community, is get data out when we could. We've been -- in a lot of the calls we've held recently and hosted, we've heard the feedback, and we want to make sure we're getting data out as soon as we possibly can. So what we did here was recognizing the fact that it's a long time for some of the major medical conferences. We tried to get some data out as quick as we could, and then we want it to be meaningful data. So we tried to provide some extra data here, which is hopefully useful to everyone. That doesn't stop us from having meetings, having presentations at meetings, and we intend to do that. With respect to 3A, 3A is one of the cohorts that's active in COM-202, obviously, and we've been -- we mentioned several times today, I can't commit to any dates on that, except to say that stay tuned on that, and we will try to get data out as soon as we can, just like we did with 3B.

Our next question comes from Nick Abbott of Wells Fargo.

So other than the 6 patients in the swimmers plot, are there any other patients still being followed on the protocol? And if so, how many? And why were 4 patients efficacy ineligible? And I have a follow-up.

Friedrich, why don't you answer those, please?

Sure. So on the patients in follow-up, again, that's a question related to the entire larger population. So we'll give updates and summarize that at the upcoming medical conference. Typical reasons for patients being nonevaluable is if they are not on study long enough in order to make the first tumor assessment. So it...

Okay. And then I guess if I think back to the head and neck data, there was a 38% response rate, but duration was considered suboptimal. So why do you consider these data in lung encouraging given such a limited follow-up? And what additional response duration should we expect at the time of data presentation?

Friedrich, are you going to answer that one?

Yes. So I think really what interests me in this data set and why we think it's worth showing and why we also think there is value in sharing this with the scientific community is this additional driver for enrollment in our programs is the response rate. Seeing a response rate above 20% in this population, which is similar to what we've seen with the first checkpoint inhibitor studies post platinum doublet chemotherapy when pembro and nivo were approved in second or second and third-line setting, that's encouraging, particularly since these patients are more heavily pretreated than those patients because they have also seen prior checkpoint inhibitors. So I think just the response rate is worth updating the community on. Obviously, following the durability of this response will be important. But the response rate itself merits attention and sharing.

Our next question comes from Joe Catanzaro of Piper Sandler.

This is Sam on for Joe. Could you talk to us about what's the intent to treat number of patients and the data cut for this analysis?

Friedrich, could you take that one, please?

So the data cut for this -- let's start with that one for this presentation that's very recent, it's the 24th of June, just last week. We are considering sharing information around the entire population as part of our upcoming presentation. But just this context, I think we've shared in the past, the success rates across indications in our entire portfolio being above 90% in regards to manufacturing.

Okay. Great. And then could you also just talk to us one more about the decision to close enrollment?

Friedrich, do you want to handle that? I mean, it wasn't -- it was -- it reached a predefined size. But Friedrich, please comment on that, if you want.

Yes. No, I think that's exactly it. You've predefined, you accept some over enrollment, obviously, in these types of signal-generating studies like this one, you have some flexibility there, and you get it to a point of where something is decision-enabling and gets you the confidence that you need to then build on that. In this case, for non-small cell lung cancer, we've described the LUN-202 study. That really is the study that is the next step, building on the data from this study as well as on the data from our collaborators at the Moffitt, which Madan described. So really we have taken it to the next step and now bringing this therapy to a more homogeneously and better defined population with less prior therapy and better comparability with benchmarks.

Thank you. At this time, I'd like to turn the call back over to Fred Vogt for any closing remarks.

Thank you, operator. With that, we'll close today's call. I'd just like to thank all the teams at Iovance, all the patients and their families, everybody who participated in the study, all the investigators for their help with cohort 3B. I thank all of you for your attention. Have a nice afternoon.

And this concludes today's conference call. Thank you for participating. You may now disconnect.