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2026.10.05 | TB | Pharma | Daiichi Sankyo DESTINY-Lung04 Update

原标题：Daiichi Sankyo – DESTINY-Lung04 Update

#pharma

Third Bridge · 2026-10-05

Analyst-led • 25 Sep 2026

Companies: 4568 JP, AZN GB

Gilles Gallant (GG) Member, Research Advisory Board at MBrace Therapeutics Inc

Michelle Lee (ML) — Third Bridge Sector Analyst

Agenda

Key Insights

Introduction

ML [00:00:03]: Welcome to Third Bridge's Interview entitled Daiichi Sankyo – DESTINY-Lung04 Update. I'm Michelle Lee, and I'm joined today by Mr Gilles Gallant.

Before we start today's Interview, please state I agree or I disagree to the following statement: You understand the definition of material non-public information and agree not to disclose any such information, or any other information which is confidential, during this Interview.

GG [00:00:36]: I agree.

ML [00:00:37]: Could you begin with a brief introduction to your background?

GG [00:00:45]: Thank you, Michelle. My name is Gilles Gallant, and I was Chief Development Officer at Mythic Therapeutics until one year ago. I am now a consultant for different biotech companies. I'm a member of different scientific consulting companies. Prior to Mythic Therapeutics, I worked for five years at Daiichi Sankyo as the Senior Vice President of Clinical Oncology. I'm well aware of the DESTINY-Lung04 study and happy to discuss this with you today.

Questions

00:01:34] Recently, WCLC [World Conference on Lung Cancer] 2026 was held in Korea. Enhertu demonstrated a median PFS [progression-free survival] of 14.3 months as a first-line treatment, which shows significant superiority over the standard of care. How do you think these data will shift the first-line NSCLC [non-small cell lung cancer] treatment paradigm?

GG [00:02:15]: Let's first make sure people understand that first-line non-small cell lung cancer is a very big indication. That particular study was performed in patients with HER2-mutated non-small cell lung cancer, which is about 2-4% of all non-small cell lung cancer. It is also different from the HER2 overexpressed non-small cell lung cancer, which we may discuss a little bit later. Currently, as we speak in the US and elsewhere around the world, it is approved Enhertu as monotherapy for that particular patient population in patients that have prior systemic therapy, but this indication was based on a small study, and it's under accelerated approval in the US. Now the data that you just mentioned, the DESTINY-Lung04 with a median PFS of 14 months is actually in first-line non-small cell lung cancer in patients with HER2-mutated cancer. If you look and put that in perspective, you have currently in the NCCN guidelines, the version is version 8, 2026.

It's on page, by the way, NSCL-36. You have two drugs, two possibilities for those patients. Zongertinib, which is also indicated in first-line non-small cell lung cancer, but it is based on a small study, and it's under accelerated approval as well. The other options you have is systemic therapy. With a median PFS of 14.3 months, Enhertu would go to first line and competing in a way with systemic therapy, which it has beaten in that study and zongertinib, which has, if you look at the number in first line, a response rate of 75%, which is quite similar to Enhertu at 70, but a median duration of response in the label, which range from 1.3-15-plus months, while Enhertu has a median duration of 13.4 months. Difficult to compare because in the case of the TKI, you have only 71 patients. In the case of Enhertu in DESTINY-Lung04, you have 227 patients treated. This is clearly an unmet medical need area. Clearly, when it is approved, this is most likely going to be in the NCCN guidelines as a first-line choice.

00:05:46] If we look at the data a bit more deeply, there's some evidence of Enhertu's superior PFS, like 14.3 months, but the interim overall survival trend is that systemic treatment is four months longer. How will regulators reconcile this with Enhertu's acceptance as a first-line therapy? I think overall survival is a more important indicator for choosing treatment.

GG [00:06:54]: Again, let's look and think about that particular setting, a real unmet medical need. You have an improvement in PFS of about six months. This is statistically significant, of course, but more importantly, clinically significant. DESTINY-Lung04 was actually a study that was to confirm the DESTINY-Lung02 and DESTINY-Lung01 studies that showed that the drug had activity in second-line HER2 mutated patients. Now DESTINY-Lung04 study as a confirmatory study, went to the FDA, was reviewed. At the time, FDA agreed on PFS as the primary endpoint. This is important because the way the study is designed is the PFS is the primary endpoint, but overall survival is a key secondary endpoint. Now it's a very important endpoint, but if you think about it, if the FDA and other global health authorities accepted the protocol, is that they were ready to accept PFS as the reason to approve the drug as long as there is no detriment in overall survival. Now the data that has been quoted at the meeting in Korea shows that it's very immature, meaning that there's not that many patients that actually have an OS endpoint yet.

The problem is, in addition, according to the company's press release, there are imbalances between the use of secondary therapy. After the use of Enhertu first line, there are significant imbalances as to what they received after that particular study that could explain the early overall survival results, but importantly, they will need to perform a real overall survival analysis much later when they have way more events in that particular study. It's interesting, though, if you look at the study, the way it was originally designed, there was to be 264 patients to be enrolled in the study. However, the companies did an amendment to the protocol, and they actually enrolled 454 patients. The question is, why did they do that? I suspect that they did that to have, first of all, a faster response, a faster answer to the overall survival question, and increase the power to actually detect a statistical difference. Now they've talked about the results at this meeting in South Korea. However, these results are much too early to really make sure that this is a real finding, but in any case, the study was designed to show a PFS difference, and this is what they reported at the meeting.

00:10:55] This monotherapy arm showed an ILD [interstitial lung disease] incidence rate of over 20%, including several grade five really severe events. How might this toxicity profile complicate the regulatory review for the first-line approval?

GG [00:11:21]: That's a real good question. Now in the Enhertu development, since the beginning and very early in phase 1, those ILD pneumonitis events were identified very, very quickly. The drug has been approved since 20 December, 2019, in the US. We are aware of the safety profile of the drug. The drug was approved initially in breast cancer, as you remember. Now the ILD pneumonitis is not surprisingly more frequent in patients with non-small cell lung cancer. In DESTINY-Lung02, for example, in 100 patients, the ILD rate was about 15%. In DESTINY-Lung01, in 91 patients at a higher dose, though, they reported an ILD rate of 26%. These data have been either in the FDA-approved label or in the New England Journal of Medicine article. The data at 20% for DESTINY-Lung04 is in a similar range as previously seen with other HER2 lung cancer study. Importantly, if you look at the label in the US and elsewhere around the world, there are no black box in the label for ILD pneumonitis, and ILD pneumonitis is not included in the warning and precaution section of the label.

It's important to say that because it's a drug that has been extensively studied in breast cancer, in gastric cancer, in lung cancer and other tumour types as well. Finally, one thing that is very important, the ILD incidence varies tremendously according to the tumour type, the number of prior therapies, if you had prior instances of ILD, the ethnicity is extremely important. We know for a fact that Japanese patients are much more sensitive to this effect compared to the Asians in general and compared to the Caucasians. If that particular study was to have many Japanese patients, for example, that might influence the numbers at the end. Finally, the combination drugs, if you combine the drug with other drugs that have potential ILD effect like a PD-1 or PD-L1 inhibitor, then you have a chance to have a little bit more ILD. Now in the case of DESTINY-Lung04, that was a single-agent study. That 20%, as I mentioned, is in the range of what we've seen in other studies.

00:14:53] What innovative patient management strategies are necessary to successfully establish Enhertu in the first-line lung cancer setting?

GG [00:15:13]: That's a very good question. I think that HER2 mutated non-squamous non-small cell lung cancer as well as HER2 IHC3+ non-small cell lung cancer are relatively small indications. It's maybe 2-4% of the patients overall. When you compare that to breast cancer, it's two different world. There's many more patients with breast cancer that receives this drug. The thoracic medical oncologists that actually treat lung cancer, they're not going to see those patients very frequently because it's a low rate of incidence. What they need to do is actually test those patients for those mutations and test for IHC to really identify those patients. In addition, those companies, AstraZeneca and Daiichi Sankyo, really will have to increase their efforts to really inform the physicians about that particular drug. One final point is that patients that have EGFR-mutated disease, when they progress, one of the progression factors that you will see is seeing those HER2 mutations. There may be an additional group of patients there that might be eligible for this drug that were not necessarily in first-line receiving or actually showing an HER2-mutated disease.

00:17:15] If you are trying to move Enhertu from the second-line to the first-line setting, what is your realistic estimate for the timeline covering full regulatory approval and subsequent integration into the clinical practice guideline like NCCN [National Comprehensive Cancer Network]?

GG [00:17:39]: Let's talk a little bit about the regulatory approval. As I mentioned at the beginning, Enhertu is currently approved in second-line HER2-mutated patients. This would be the confirmatory study that would actually move this into first line. When it was approved in second line, Enhertu had received FDA breakthrough therapy designation, which actually accelerate the process to get the approval. If you look at this, this goes pretty fast. Now in first line, currently, they do not have breakthrough therapy designation. However, I'm pretty sure that companies like AstraZeneca and Daiichi Sankyo will probably request to have breakthrough designation with the data that we know. That famous 14.3 months vs the 8.3 months in chemotherapy. With that, they may get really acceleration to get this full approval. In addition, I would not be surprised, in fact, I'm pretty sure that those companies will also make sure that this is reviewed under Project Orbis, which will allow the approval of that particular indication in many other countries around the world based on the US FDA review.

Now for the NCCN guidelines, knowing that the data is quite exciting and knowing pretty well how those companies work, they will be assembling a dossier, so a file, for the NCCN review committee to evaluate the data. Now usually, you submit to the health authorities and then you get the approval and then the NCCN reviews and then get the approval. However, I know that those companies can actually prepare the files while they are preparing the files for the regulatory approval at the same time as preparing the files for the NCCN approval. By the time the drug is actually approved, the new indication, the NCCN is in a position to actually put that immediately in their guidelines. In addition, the NCCN non-small cell lung cancer panel, the people that are part of this committee, the members, they are known. If you look at the NCCN website, you can find the names of all those people that are reviewing this. I'm pretty sure that companies will be sharing the data that has been presented at the World Conference in Seoul in advance. I would not be surprised that at the time of the approval, the NCCN guidelines are immediately implemented at the same time.

00:21:16] What treatment options should follow for patients who already experience progressive disease after first-line Enhertu? How can we strategically sequence treatment to overcome HER2 [human epidermal growth factor receptor 2] downregulation or resistance to the DXd?

GG [00:21:42]: If Enhertu becomes standard of care in first line, then in second line, there are still those TKIs that exist. Zongertinib is one of them. There's a new very recently approved sevabertinib as well that has been approved and can be given in second line in those patients. Chemotherapy will remain as an option as well, but as you can see, if in first line Enhertu can beat chemotherapy, in second line, it's unlikely that chemotherapy will be much more effective. Now things will change in the future. Zongertinib is, I think, a Boehringer Ingelheim drug, and they are also approved with accelerated registration. They need to complete a successful confirmatory study to obtain full approval. They actually perform the phase 3. According to Clinicaltrials.gov, the enrolment has been completed with 428 patients on 2 September, 2026.

They anticipate the data to be available on 28 January, 2028. There will be competition in first line with that particular drug if the drug, of course, has a successful study. The endpoint is the same. It's PFS and the key secondary endpoint include overall survival, response rate and so on. Sevabertinib, which is the other agent that has been recently approved, also need to get a successful confirmatory study. However, there has no confirmatory study for this particular drug currently listed in Clinicaltrials.gov. It may take them a little bit longer, but zongertinib might be in first line as well, maybe possibly in 2028. There's a lot of competition in this particular area with only 2-4% of non-small cell lung cancer patients.

ML [00:24:22]: Is it very crowded?

GG [00:24:25]: Yes.

00:24:30] Let's talk about the combination strategies, given that the triplet combination in DESTINY-Lung03 was limited by excessive toxicity. Should Enhertu's combination strategy in NSCLC pivot away from the immuno-oncology agent or any other future partners available?

GG [00:25:02]: To me, the answer is no. I think the combination of Enhertu with PD-1 or PD-L1 inhibitors that has shown to be very effective preclinically, but also in patients with non-small cell lung cancer. I'm talking about patients with non-small cell lung cancer in general, not specifically those with HER2 non-squamous non-small cell lung cancer. I think there is still a place to combine Enhertu with PD-1, PD-L1. Preclinically, it shows synergism and/or additivity. I think there will be studies studying that particular combination. The issue with DESTINY-Lung03 was really combining Enhertu with chemotherapy. This is very challenging as we heard from the study results due to the overlapping toxicities. When you give chemotherapy with Enhertu, you see a high rate of febrile neutropenia, of thrombocytopenia and other drug-related serious adverse event. It may not be the way to go in that particular disease. I mentioned previously, zongertinib and sevabertinib. I think these drugs are active in patients with HER2-mutated disease. These could be partners with Enhertu. If you look at the toxicity profile, it's quite different. It may make sense to combine those drugs in that particular patient population.

00:27:05] What combination therapy strategies would be most effective to successfully expand into the HER2-overexpressing NSCLC population?

GG [00:27:22]: I think, as I mentioned, zongertinib and sevabertinib would be probably the preferred one, but really, if you want to expand this particular area, because currently, the actual indication would read patients having metastatic disease, for example, or locally advanced disease. However, there are possibilities to bring these drugs much earlier in the disease. If they have stage 1 or stage 2, maybe use adjuvant therapies or neoadjuvant therapies might be where you could expand significantly that particular use, either as single agent or in combination.

00:28:19] There are many other novel modalities and ADCs [antibody-drug conjugates] rapidly advancing in the NSCLC space. How does Enhertu maintain a durable competitive advantage in the frontline setting over the next 3-5 years?

GG [00:28:47]: There are a large number of HER2 ADCs out there being developed. Some of them are with different payloads like MMAE, for example, or other different payloads. That seems like a good idea, if you will, to try to develop those drugs and see if that would work in patients that either have received Enhertu before or even before giving Enhertu, are they going to be more active? What's important in this particular area would be the understanding of the mechanism of resistance. Those patients that receive Enhertu and then progress, what is the reason why they're progressing? Are they progressing because the drug doesn't internalise, for example, or the payload is no longer active?

There's a resistance mechanism there. Depending on how we understand from that mechanism of resistance, then you can give different ADCs in HER2 ADCs in that particular setting. Now would other ADCs that are not targeting HER2 be as effective, that would be a little bit surprising. You have TROP2, you have HER3, you have other agents that are coming up, but again, what is defining the disease, this HER2-mutated disease, it's all based on HER2. You need to have a drug that really targets the HER2 receptor, if you will. Drugs that have different receptors might be used later on, but probably are not going to be as effective in first-line therapies.

00:30:57] We were talking about efficacy vs toxicity. If a competitor develops an HER2-targeted agent with a slightly lower objective response rate but a significantly better safety profile, how competitive could it be?

GG [00:31:29]: That's a very good question. DESTINY-Lung04 now will create an efficacy bar for other potential competitors. Of course, a PFS bar, other drugs will need to be as effective, if not more effective, but if there were to be an overall survival advantage at the end, then people will prefer to receive the most effective agent, even if that means they have a little bit more safety risk. However, if everything is equal in terms of efficacy, in terms of PFS and OS, of course, then toxicity becomes an issue. I'm basing that on the fact that if you are a patient and you have non-small cell lung cancer, this is a bad disease, and you want to have as much efficacy as possible. You're willing to tolerate a little bit more risk, and that's really the case. I'll point out also that drugs like zongertinib and sevabertinib, they do also have toxicities. It's not lack of toxicities. There are different patterns of toxicities, and that includes also ILD, not as frequent as Enhertu, of course, but it's there. Something to remember as well. Again, I think Enhertu has just put the bar. If ever the OS is really significantly longer, the other drugs will have to demonstrate the same, if not better efficacy.

00:33:26] You mentioned that HER2-mutant NSCLC is 2-4% of total NSCLC. How can Enhertu's potential commercial ceiling in this area be overcome considering the small target population?

GG [00:33:48]: It's going to be a challenge, of course. In HER2, it's very positive data that we've heard about. We hope the overall survival would be also positive. The drug is already used in non-small cell lung cancer in the second line. Also, don't forget also in those patients that have three-plus IHC, HER2 overexpression. It just gives you even more certainty, if you will, that the drug works very well in lung cancer. One of the indirect effects, I think, will be that we'll see possibly an increase of use of the drug in patients that have HER2 overexpression. Those patients, by the way, it's about 1-5% of patients with non-small cell lung cancer. That's an additional group. It gives you a little bit more confidence that the drug will also work there. As I mentioned also, one area that is interesting is those that have EGFR.

EGFR-mutant disease is treated with tyrosine kinase inhibitor TKIs, and the TKIs works very well, but when they actually don't work anymore, one of the mechanism of resistance appears to be HER2. It is amplified in those patients in, from what I read in the literature, about 12-13%. That could be a very significant group that could benefit from Enhertu in that particular patients. One of the most important part, though, in all of this is to make sure that physicians detect those alterations. Testing non-small cell lung cancer for HER2 will become very important. If you want to expand the group of patients receiving this drug, you need to identify those patients. I think that's extremely important. It is routine in the US at least, but they may not be routine elsewhere. Something to think about making sure that the testing is being performed.

00:36:26] If Enhertu successfully captures the first-line NSCLC indication, what is your estimate for its potential peak annual sales in this indication? What is the possibility of expanding, like EGFR [epidermal growth factor receptor] for HER2 mutation or the case you've mentioned?

GG [00:36:59]: I'm not a marketing person, so I'm not a specialist there. It's difficult for me to say that. However, as part of my job in the past, I was sitting on the sidelines where these estimations were made. I was there to make sure that the numbers, the percentage of patients that they think they're going to be able to treat with, were reasonable. However, because of the level of evidence we're going to get from that particular study, this is a phase 3 comparative study against the standard of care chemotherapy, I think Enhertu should be able to take a very significant percentage of the first-line HER2-mutated non-small cell lung cancer. The two other drugs, zongertinib and ultimately, when sevabertinib is approved and possibly in first line, it is approved in first line. I'm sorry that it's in NCCN. The data we have in their label is very, very small, small number of patients. Uncertainty about duration of response. No data on PFS and certainly no data on OS. Enhertu should be able to take a very big percentage of the first line and really move chemotherapy from first line back to second, third or maybe fourth line.

00:38:39] What does the adoption curve look like for Enhertu assuming this first-line approval? How rapidly would you expect to displace the standard of care?

GG [00:38:57]: You know that new standard of care tend to be established quite quickly in oncology after publication, after an ASCO meeting, an ESMO meeting or a World Lung, as the data is disseminated and people tend to really change their pattern of their standard of care very, very quickly. Again, because the study is a phase 3, it's 400 patients compared to a standard of care, I think that this will provide a very high level of evidence. The other drugs that can be administered in that particular setting may have similar efficacy, but it's not proven, I think that it's going to be really quickly adopted by the physician. Now it's all a question about who reimbursed this. Sometimes you need to have the actual approval from the FDA or the approval from NICE in the UK or approval somewhere else. It's sometimes difficult to get the drug until it's actually approved by the health authorities.

00:40:22] Previously, when Enhertu was expanding its indication in the breast cancer space, have you seen any demand or attempt to prescribe it off-label after data release, but before the approval? Are you expecting similar cases in NSCLC for now?

GG [00:40:56]: I was at Daiichi Sankyo when we got the approval in breast cancer. I was there several years after that. There were requests already at that time for patients to receive the drug even in non-small cell lung cancer. We didn't have approval in non-small cell lung cancer. Those patients that can actually afford it, even though it may not be paid by insurance, we already had use there. Now that's in the US and it's probably very specific to the US. I don't think it's the same thing elsewhere in the world. Don't forget, even if you have limited data available, you have an enormous amount of data on Enhertu in general, in breast cancer, in gastric cancer, for example. People are comfortable with the drug. They know it's active, and they heard about this non-small cell lung cancer, DESTINY-Lung04 study. It wouldn't be a surprise at all that there is some use. Now is it going to be a tremendous amount? I don't know, but it will. I can tell you for sure, this will happen.

ML [00:42:22]: In that case, what are the practical mechanisms for securing payer coverage? How often will insurance approve it for off-label use in the US?

GG [00:42:47]: Countries and regions have very, very different approaches to pricing. Now we have with Enhertu a very significant amount of data supporting its use in several tumour types. Now AstraZeneca and Daiichi Sankyo will need to really convince governments of the very positive risk-benefit of Enhertu in patients with HER2-mutated non-small cell lung cancer. Now it's a small group. It's easier for government budget to support it, but if you look very, very recently, I think on 16 September last week, NICE in the UK recommended Enhertu for routine use in NHS in England for people with HER2-low advanced or metastatic breast cancer.

This is a huge group of patients compared to non-small cell lung cancer, it's enormous. NICE can find that this drug really improved survival, PFS in general and can support this in HER2-low breast cancer. It wouldn't be surprising that they will most likely approve the drug also ultimately in non-small cell lung cancer as well. This takes time in most countries because you need to have the approval first from the regulatory authorities and then the pricing negotiation and so on. Again, this is a relatively small slice that you're adding to the much bigger slice of Enhertu budget for breast cancer and gastric cancer and other tumour types.

00:44:52] What flexible pricing strategies are necessary to achieve commercial success in this first-line setting for Enhertu Amid global healthcare budget constraints?

GG [00:45:10]: First, I'm not aware. I would be very, very surprised that AstraZeneca or Daiichi Sankyo would request, for example, premium pricing for frontline Enhertu in patients with HER2-mutated non-small cell lung cancer. That would be extremely surprising. In fact, I think that Europeans, for example, will request a lower price for the drug because it becomes a larger and larger, bigger piece of the pie in their drug budget for lung cancer. I think that will be negotiated for sure, but again, if you are improving survival and we don't have the data yet about that, but if that's the case, it becomes more and more difficult for HTAs to refuse to actually pay for a drug like this to reimburse because of the implication. It takes time. It's a long process, but I think that ultimately, if you have OS advantage, then there's going to be very, very difficult for them not to approve it.

00:46:32] How long does it take to prove the final OS data?

GG [00:46:42]: It's going to take a little while. You saw that in their press release, they talk about 40%-somewhat of patients of the event data. If you look at the PFS data, you have a median PFS currently of 14 months. It means that all those patients, the midpoint is actually 14 months, but a lot of patients, half of the patients actually have a PFS longer than 14 months. First step is to get the PFS, then they get another drug, then possibly another drug. Then ultimately, unfortunately, they passed away from their disease. Just imagine how long it can take from there to actually getting to the end there. Currently, the median OS is 29 months for that, 33, I think, for the chemotherapy, but it's going to take a little while before getting there because the number of events is certainly not there. At this point, even though it's not statistically significant, it's not powered at this point to be statistically significant. I wouldn't worry too much about that.

00:48:10] Would the health technology assessment bodies, regulators or insurance payers push back against premium pricing for Enhertu, given the high cost associated with severe adverse events like ILD?

GG [00:48:39]: Again, the data is very well-known for this particular drug. They are aware of the side effect profile of this particular drug. When it was originally approved in breast cancer, the percentage of ILD was a little bit high because at the time, in breast cancer patients, we weren't aware of what ILD would be and so on. We have now learned about this. The rates are a little bit lower, but that's a risk. It's an important risk. If it's not treated very rapidly with steroids, for example, it can really rapidly degenerate. Unfortunately, some patients have died from this. This is an extremely important area.

Now when the pricing of drug, and I'm not a specialist here, from what I understand, it's unlikely to go up because of an additional indication. That's simply because, again, you're asking governments and regions to pay for more patients being treated with the drug. It's tough for them already. It's an expensive drug. Getting more patients on it will cost more. There's no reason to actually go and increase the price at this point. There's always the inflation every year, companies increase the price of their drug because of inflation, but this is not, I think, going to be a way for Enhertu in the future, and particularly in Europe and Australia and places like that, where the control of price is extremely important.

00:50:40] I thought the DESTINY-Lung01 to 04 trials represented a massive investment in clinical trials. How can they offset those expenses by selling to such a small population of patients with HER2-mutated NSCLC?

GG [00:51:11]: It is a small population. However, I think for the image of the drug, it's important to show that the drug works in different areas. Remember that they got this study called pan-tumour as well in patients with all sorts of tumour types that have either an HER2 alteration or an overexpression of HER2. This is a huge group of patients as well. When you demonstrate that you have activity in several different diseases, it just reassure you that the drug really works in many, many patients. I think even though it's an investment, it's 400-patient study that was done globally. I think it's very good for the image of the drug that it really demonstrates an advantage here for patients.

00:52:15] Given Enhertu's massive established commercial success in the breast cancer area, does it still need to demonstrate overwhelming success in the NSCLC space, or would a more modest clinical or commercial impact in the lung cancer area be strategically acceptable for Daiichi Sankyo and AstraZeneca?

GG [00:52:49]: Non-small cell lung cancer, HER2-mutated and even if you had the patients with HER2 3+ IHC, it's a relatively small, very small indication compared to breast cancer or even gastric cancer for that. Gastric cancer is very frequent in Asia, for example. Again, I think for the drug image in general, it's important to demonstrate that this drug works also in non-small cell lung cancer, but does it need to be overwhelming? No, it's an option. In this particular case, again, it's going to be approved because PFS is the main endpoint. The health authorities have accepted it, and it's a really confirmatory study. It will get improved.

The difference of six months in terms of PFS is very significant. It is something that is eye-popping. Remember, recently, we had the RAS drug that have demonstrated in pancreatic cancer a six-months improvement in survival and everybody was floored. Here, it's not survival, it's PFS, but it's a six-month difference. It's the same kind of difference. It is for patients something very, very important for them. Of course, it is important for non-small cell. Is it going to be an overwhelming success? There is competition, as we mentioned throughout the talk here. It's going to be successful, but probably not as much as a success maybe in breast cancer or gastric cancer.

ML [00:54:47]: Still is fine.

GG [00:54:50]: No, I think it just adds up and means the drug works very well in different diseases. It gives confidence to investigators about that particular drug.

ML [00:55:04]: Maybe it is to help convince other people of Daiichi Sankyo's other ADC portfolio.

GG [00:55:15]: It was the first in the portfolio. As you saw, many other drugs are coming up the pipeline, very interesting drugs. I'm following that with a lot of happiness to see that this can help other patients with other diseases as well. It's a first. HER2 was an excellent, excellent target. The other targets, TROP2, B7-H3, CDH6 and so on, these are different targets, may not be as successful as HER2, but it will help patients and improve, hopefully, their survival after all. In the case of Enhertu in breast cancer, you've seen the recent results in adjuvant and neoadjuvant breast cancer, and these are spectacular. You may even think that you may be able to cure some patients with very, very early disease. That would be overwhelming spectacular for that particular drug.

ML [00:56:33]: Thank you very much. I think that's about all we have time for today. I want to say thank you for joining me and sharing your valuable insight.

GG [00:56:45]: Thank you for the opportunity, and happy to talk about this. It's an exciting time to be in oncology.

ML [00:56:55]: Yes. Thank you very much.

GG [00:56:57]: Bye-bye now.

ML [00:56:59]: Bye.

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