Exelixis at TD Cowen’s Summit: Strategic Growth in Oncology

On Tuesday, 27 May 2025, Exelixis (NASDAQ:EXEL) participated in TD Cowen’s 6th Annual Oncology Innovation Summit, offering insights into its strategic initiatives and future growth prospects. The discussion highlighted both the company’s promising pipeline and the challenges posed by regulatory changes. Exelixis emphasized its commitment to data-driven decisions and commercial execution to drive growth in its CABOMETYX franchise and neuroendocrine tumor (NET) launch.

Key Takeaways

• Exelixis aims to expand the CABOMETYX franchise from $2 billion to $3 billion by 2030.
• The recent NET approval is expected to drive growth, with a strategic focus on data-driven marketing.
• The company is addressing the impact of the IRA changes on its Medicare-related rebates.
• Exelixis is advancing its ZANZA pipeline, focusing on CRC and head and neck cancer trials.

Financial Results

• CABOMETYX Q1 Performance:

- Driven by increased prescriptions and market share in RCC.

- Included a $12 million clinical trial order, maintaining a historical range.

- NET approval had minimal Q1 impact due to its late-quarter approval.

- Gross to net ratios remained stable.

• Impact of IRA Changes:

- A 1% rebate phase-in due to Medicare business percentages, with improvements seen over the quarter.

- Initial disruptions in January, with stabilization by March.

• Future Growth Projections:

- CABOMETYX is projected to grow significantly, aiming for a $3 billion franchise by 2030.

Operational Updates

• CABOMETYX Commercial Strategy:

- Emphasizes the robustness of five-year survival data, with no erosion seen in trials.

- Focused team ensures CABOMETYX’s role in every RCC patient’s treatment journey.

• NET Launch Strategy:

- Targets patients on oral cytotoxics, leveraging CABOMETYX’s data.

- Plans to market data compliantly, highlighting benefits over generic options.

• ZANZA Pipeline:

- Prioritizes liver mets patients in the Stella 303 study.

- Aims to learn from past trials to enhance trial designs and outcomes.

Future Outlook

• CABOMETYX Growth Drivers:

- Sustained momentum in the core business and new NET launch.

• ZANZA Studies:

- Stella 303 data expected in the latter half of the year.

- Stella 305 phase two results will guide future decisions.

• Early Pipeline:

- Focus on bispecifics, particularly the PD-L1 NKG2A bispecific program, combining adaptive and innate immunity mechanisms.

Q&A Highlights

• IQVIA Data Accuracy:

- Considered directionally accurate but subject to seasonal and algorithmic variances.

• 1% Rebate Specifics:

- Tied to overall discounts and patient burdens, not a direct sales rebate.

• Nonclear Cell RCC Trial:

- Aims to establish a new standard of care, with data expected later this year.

Exelixis continues to leverage its robust data and strategic initiatives to drive growth in the competitive oncology landscape. For more detailed information, readers can refer to the full transcript below.

Full transcript - TD Cowen’s 6th Annual Oncology Innovation Summit:

Yaron Werber, TD Cowen biotech team, TD Cowen: Well, good afternoon everybody, and thank you once again for joining us for the sixth Annual oncology innovation summit. I’m Yaron Werber from the TD Cowen biotech team, and it’s a great pleasure to have with us today. Really needs no introduction, Andrew Peters, senior vice president of strategy, and a former very well esteemed wall, Wall Streeter. So, Andrew, thanks for joining. We appreciate it.

Andrew Peters, Senior Vice President of Strategy, Exelixis: Yeah. Thanks for the invite invite. You know, love, love doing these sorts of things.

Yaron Werber, TD Cowen biotech team, TD Cowen: So, lots to cover. We were just talking. We only have twenty five minutes. And with Exelixis, there’s really a lot going on these days. So let’s kinda dive right into let’s talk about commercial first.

So Cabo had a very strong q one, you know, driven by by, you know, several things. Number one, prescriptions continue to go up. It’s obviously we continue to capture share in RCC. There was a a 12,000,000 clinical trials order, but for the audience, historically, that’s ranged between 4 and 22,000,000 per quarter. In the last two years, it’s kind of ranged between 4 and 12.

So, you know, it kind of fluctuates up and down a little bit. There was very little you said on the NET approval, the neuroendocrine tumors. It was only approved a week. There was a week left in the quarter. And the gross to net was mostly in line.

So I guess the the first question is IQVIA the the trackers really didn’t do a good job tracking this quarter. Usually, they do. I know there was a usually a gross to net benefit or a Part d. The Part d reset, I think, was also a tailwind. You don’t have to pay under SG and A for the co pay support, but that’s an SG and A line.

That’s not a revenue line. So I guess the question is why what else are we missing? Did something happen on the three forty b channel? Or why wasn’t IQVIA tracking it well this quarter?

Andrew Peters, Senior Vice President of Strategy, Exelixis: Yeah. So, you know, great great set of questions there. So kinda we’ll we’ll we’ll jump right into it. I I I guess before I start, actually, wanna, as a reminder, we’re gonna be making some forward looking statements today. So please see relevant risks and disclosures in our regulatory filings around any of the forward looking statements today.

So, you know, obviously, a couple of weeks ago, reported 1Q results, very strong results. Couldn’t be more excited about how kind of the business is shaping up. And as we’ve talked about, you know, we think we’ve on the been on this cusp of a breakout for a while, not only kind of with the core cabo business, but everything we’re gonna talk about later with Zanzan and the pipeline and all of that. But really at the heart of it is, the continued success and momentum, we have with kind of that core, cabo based business and then the newly nascent neuroendocrine tumor launch. You know?

So within that, we think really kinda there are a bunch of components to keep in mind. You know, the first one is all drugs and their success commercially come down to two things, the data and the team. And as it relates to kind of cabo and this continued momentum that we’ve had, it really is an outlier. So if you think about most drug launches tend to hit steady state, you know, five to seven quarters post new indication launch. And we’re now four years plus into cabonivo and frontline RCC based on the back of the nine ER data.

And so we’re clearly an outlier there, and the question becomes why. You know, a big chunk of that, as I mentioned before, is the data. So at ASCO GU, in January, we actually had the five year kind of final survival data, five year update. And, you know, kind of the key message, from that dataset is something that resonates kind of on the KOL side, resonates on the physician side, certainly resonates on the patient side, is that erosion that often times you see, as trials progress really hasn’t been seen in the the nine ER study. And so the data continues to remain robust, and that’s really why we think it it remains the number one IO TKI combo and then also kind of the number one, TKI, as a monotherapy as well.

So data. Then the second part, you know, and as Mike likes to talk about is I like to talk about, it’s really about the team as well. And so if you think about kind of who Exelixis is, we describe ourselves as a big small company. And the big side of that dynamic is that our team, we think, you know, is not only the best in biotech and our little sea of the world, but really the best in biopharma. So we have the ability with just focusing on kind of that GI, GU oncology solid tumor landscape to go out and really excel.

We don’t have distractions from other drug launches. We don’t have distractions from being kind of in that big pharma ecosystem that can have various pulls on all the reps. We have a team that’s focused on the cabo data, that’s focused on the cabo mission of really kind of making sure that cabozantinib, CABOMETYX is part of the patient journey for every patient who has RCC. So kind of those two dynamics really kind of what we think kind of drive results. As to kind of the dynamics around IQVIA, you know, I think the reality is is it’s an imperfect metric.

It’s an imperfect tool to try and help, you know, everyone, us included, get a sense of kind of how real world data are tracking. You know, the the asymmetric information here, kind of the challenges is, you know, we see every day kind of that real time sales. And Acuvia essentially uses really sophisticated algorithms to take a little sliver of the overall pie and try and extrapolate as to kind of what the pie looks like. Directionally, it can be accurate, but there’s certainly some seasonality, you know, seasonality or kind of changes within that that that can make it, you know, somewhat challenging. You mentioned, you know, gross to net, as Chris talked about.

Gross to net was a little bit higher in the first quarter, but one of the dynamics that we didn’t see this year was actually kind of relative to one q, ’24, that phase in of the the rebate period of the IRA change really was a something that was new and novel for a lot of practices last year. And January was kind of chaos. February was a little bit better. March was a little bit better than that. And kind of by April and the rest of the year, these practices understood kind of how the new rebate rules and changes around IRA, actually worked in practice.

And so that kind of impacted some of the year over year dynamics as well. So, you know, one q results, ultimately, I tend to think about a lot of that stuff as the noise. It’s really much more and as PJ talked about, kind of a demand based, you know, team based, database results that we’re seeing that continued momentum in the base business and what drove, you know, not only kind of our increased guidance, but, you know, frankly, the enthusiasm that Mike and PJ and Chris and all of us talk about around how we see Cabo growing from, you know, kind of the $2,000,000,000 plus minus franchise now to 3,000,000,000 by 2030, not only on the back of the net launch, but certainly continued momentum in that base business.

Yaron Werber, TD Cowen biotech team, TD Cowen: Okay. Yeah. That that’s terrific. The so maybe let let’s just focus on the biotechs moment factor or rebate that that phase in because that’s that’s not I you know, we don’t hear that mentioned often. That’s about a 1% rebate.

So can you can you explain what that is? Is it when one looks it up, it talks about part b, like like boy. You’re obviously much more part d, you know, like dog. So it has to do with rebating over of price increases over the CPI, but you’ve not been really so maybe talk about the the recent price increases and why this why why you qualify.

Andrew Peters, Senior Vice President of Strategy, Exelixis: Yeah. I mean, there’s there’s a lot in there. And, you know, to kinda get into the weeds, get into the minutiae of it, we’ll probably take, you know, the the rest of the time. But I think in general, you correctly highlighted, it’s a 1% rebate phase in this year. And then we qualify simply because there’s a certain thresholds and metrics around percent of revenue dedicated to, you know, essentially Medicare business.

And, you know, we qualify under under that that metric. You know, one one of the things that I often joke about is anytime you try and kind of extrapolate as to what’s gonna happen in the future as it relates to what government programs are gonna do, you know, no one knows. But I think, you know, the best way to think about it is for this year, it’s kind of that 1%, rebate, as opposed to kind of the the the differences that that pharma faces either in the phase in or the catastrophic period, and that’s around that kind of 80%, threshold that we qualify for.

Yaron Werber, TD Cowen biotech team, TD Cowen: 80% of sales. Right? Yeah. Related to that drug. But you you do not get that rebate from next year onwards.

Right?

Andrew Peters, Senior Vice President of Strategy, Exelixis: So, again Based on the IRA. Getting into the specifics. It’s a phase in period, over time that the small small manufacturers, qualify for. So it’s 1%, and it grows incrementally from there. But, again, kind of there’s a, you know, a little bit of we’ll wait and see as to how that actual change, actual implement implementation goes over time.

Yaron Werber, TD Cowen biotech team, TD Cowen: So that’s a 1% that’s literally 1% of sales to Medicare over

Andrew Peters, Senior Vice President of Strategy, Exelixis: No. It’s it it’s it’s a little bit more kind of complicated than that. It’s not a 1% of sales. The total sales is more the the threshold, around, do you qualify for the exemption or not? The the rebate period is is the 1% rebate amount.

Got it. Okay.

Yaron Werber, TD Cowen biotech team, TD Cowen: But that’s a rebate back to the company. Right? Or the or something of of what you don’t need to pay to Medicare Or what It

Andrew Peters, Senior Vice President of Strategy, Exelixis: it just it’s it’s related to kind of the overall discounts that I mean, the the purpose of the overall, legislation was to, you know, ultimately impact how the the burden that the patients face. And so the percent of that burden that falls on various participants in the ecosystem, whether it’s the manufacturer, whether it’s the insurer, whether it’s Yep. Medicare, etcetera, in the patient. And so it’s it’s that component that the small manufacturers In the catastrophic phase. Yeah.

Correct. That are treated differently than, say, large, you know, conglomerate pharma sort of.

Yaron Werber, TD Cowen biotech team, TD Cowen: Right. It’s it’s it’s out of the 20% in the catastrophic that the industry is on the hook for.

Andrew Peters, Senior Vice President of Strategy, Exelixis: Yeah. Again, I mean, a lot of that’s just kind of, you

Yaron Werber, TD Cowen biotech team, TD Cowen: know Yeah.

Andrew Peters, Senior Vice President of Strategy, Exelixis: Very minutia y. Okay. You know, from really kind of the way that that I’ve conceptualized and I think about it as it relates to our business is really you know, that 1% is relatively de minimis to the overall hit of our business this year.

Yaron Werber, TD Cowen biotech team, TD Cowen: Yeah. Great. Let’s talk about the NET launch, coming up, though, that’s ongoing right now. You know, on the call, there was a question about, would do do you expect a bolus? And, I mean, you know, historically, right, we we both known when you’re launching into an unmet need refractory solid tumors with a new product with great data, there’s always going to be patients who are gonna wanna come and get treated, and physicians are gonna wanna use a new drug pretty quickly.

Whether it’s a bolus because of warehousing or just initial, you know, typical curve. Right? Why shouldn’t this launch go pretty quick just given the data? Broadly.

Andrew Peters, Senior Vice President of Strategy, Exelixis: I mean, so so PJ talked a little bit about this on the one q call. I mean, one of the dynamics that, you know, we consider as we think about, you know, bolus of patients or just launch curve, trajectory and dynamics is the relative state of the patients who are likely to get treated. And what PJ has talked about is given that these are later line more advanced patients, they don’t necessarily have that ability to just remain untreated while they wait for cabo approval. And so given the advanced state of in stage of these patients, we don’t really see kind of that bolus dynamic, as necessarily happening. Much different than other tumor types where you have kind of more of a watch and wait, you know, situation where, you know, maybe patients are coming in for regular scans, but they’re not being treated currently.

So the physicians have the ability to withhold therapy or kind of continue to watch and wait until the next avail the therapies on market. And so with cabo, given kind of the the nature of these advanced patients, you know, we really don’t see that dynamic playing out as much as, you know, it has in in other, you know, analogous launches.

Yaron Werber, TD Cowen biotech team, TD Cowen: Yeah. And so you you essentially got a fairly broad label. Which population do you see coming on therapy, you know, kind of the the fastest?

Andrew Peters, Senior Vice President of Strategy, Exelixis: Yeah. So I I I mean, one of the things that’s always jumped out to me kind of when I’ve listened in and sat in on a lot of the the market research and kind of ad boards and KOL panels and patient panels that we’ve done is really kind of the the breadth of the the label, not only kind of, from a regulatory perspective, but NCCN guidelines as well, is really that, you know, the cabinet data show that cabozantinib has the potential to really have a positive impact for the pretty wide, range of patients. And so what has never jumped out to me is individual pockets of PNET or EPNET or, you know, any of those dynamics who, we see as especially likely to kind of, you know, move towards, coming on to therapy. It’s more that, you know, the response has generally been near universal. You know, I always joke that, you know, it’s really rewarding and and heartening to see in this industry.

You know, when data come out, you see, you know, point 2.4 in front of the HRs on PFS. That really means you’re having quite a quite an impact on these patients’ lives. And the the totality of that cabinet data really resonates across the, you know, spectrum of nets. And because of that, you know, I don’t really think there’s gonna be any sort of pocket of, you know, accelerated uptake relative to the others.

Yaron Werber, TD Cowen biotech team, TD Cowen: K. What about Lutathera? Right? That’s it’s not the easiest drug to, you know, to to to be on, and that drug is is actually moving up. So how much of a void, is it is it really creating?

How fast is it really moving up?

Andrew Peters, Senior Vice President of Strategy, Exelixis: Yeah. I mean, you know, Lutathera’s relative to the oral options is a little bit of a, you know, somewhat unique dynamic. I think you correctly identified some of the challenges that, you know, patients and physicians have with with Lutathera. And, again, coming back to some of those ad board discussions, you know, I’ve heard anecdotally around patients who are trying to work through whether or not they’re gonna go on to something like Lutathera. Given the fact that you’re functionally radioactive for a certain amount of time.

You can’t be around children. And so if someone’s, say, a kindergarten teacher or something like that, how does that influence their decision making around whether to go on drug or not? So it’s a kind of a unique dynamic that’s starting to to emerge in the marketplace. But, really, again, what I’d point to is when we’ve talked about that billion dollar total addressable market across the oral options for these patients, you know, that tends to be kind of on the later side of things as you point out if if Lutathera goes early. So it it’s much less around taking share from Lutathera, but identifying kind of who are those patients right now that currently get some of those oral cytotoxics, and then how does Cabo and the cabinet data fit in.

And, you know, with our team, our, you know, voice share, how do we kind of go out and compliantly market to that data to make sure that patients and physicians understand the the potential benefits of the of that cabinet dataset. That voice share dynamic is certainly something that, you know, is probably underappreciated. You know, when you think about that segment, whether or not patients get everolimus, Sutent, or Captem, those are all generic options right now. So there’s really not a voice in the market, kind of advocating and, you know, really kind of driving utilization. So we think we have an the opportunity with our team to kinda go out there and appropriately frame, you know, the cabinet data and the breadth of the impact that it has, potentially has for patients.

And so, that’s kinda why, you know, you’ll always hear this enthusiasm from from us because we really think this is, you know, a great opportunity.

Yaron Werber, TD Cowen biotech team, TD Cowen: And and the the or or the SSAs, MYCAPSSA, is that branded? Chiasma, that’s part of Emirate Pharma. Are there any sort of branded SSAs at this point?

Andrew Peters, Senior Vice President of Strategy, Exelixis: Well, so the the SSAs are kind of a slightly different bucket. So somatostatin analogs depending on if the patient’s SSTR positive or negative, they’re kind of always used. So if you look at the cabinet dataset, for example, cabo was used on top of background SSA for a pretty good chunk of patients. I, you know, I always think it’s analogous to say, like, a prostate cancer market where patients, you know, remain on background kind of, you know, ADT, and then additional therapies are are layered on top of. Obviously, it’s different based on SSTR status, but, it’s something that, you know, is probably more familiar to a bigger group of investors who may not, you know, live and breathe the the net world, as much as we do.

Yaron Werber, TD Cowen biotech team, TD Cowen: Yep. Okay. Let’s move to ZENZA. Lot to talk there. So let let’s maybe move first to the, specifically to the CRC, upcoming data in the second half of the year.

So you’ve at this point now elevated, this is the Stella three zero three study, elevated the liver mets patient to be a co co primary and survival. Dual primary. Yeah. As a dual dual and and not co. The before it was really the the endpoint was in in non liver mets.

What and the the data is obviously blinded. You’re able to see a blinded dataset. What led to that decision at this time point?

Andrew Peters, Senior Vice President of Strategy, Exelixis: Yeah. So, you know, we talked about, you know, on the call and subsequent to that is really, you know, pretty simple. So if you think about it, we see blinded event rates coming in And patients with liver metastases and patients without metastases in the liver, you know, tend to have functionally pretty distinct diseases. You know, if you think about it, it makes sense that if you have a tumor that’s in the liver, you tend to have much worse prognosis, much worse outcomes, and, unfortunately, you’re much likelier to expire in a shorter period of time. So if you think about it come from kind of a blinded event rate perspective, we were seeing differentiated rates coming in in those two populations.

And so the relative maturity of those two datasets allowed us to make this change so that we can, you know, really have the opportunity to have the the widest or largest, you know, group possible. You know, we’ve we’ve talked about the liver met and non liver met populations being roughly equal from a market size perspective even though the the non liver met group’s about thirty percent. The reason for that is that, non liver met patients tend to do better, tend to live longer. They tend to be on drug longer. So even though kind of the the liver met group is much larger, the opportunity set similar.

So making this change based on a temporal analysis of the relative event rates between the two group essentially allows us to, have the opportunity to evaluate, the the biggest group possible to potentially have the an out beneficial outcome, for more patients. So it really was about kind of the the difference in the temporal event rate between the two groups that, you know, really makes a lot of sense based on the physiology of those patients.

Yaron Werber, TD Cowen biotech team, TD Cowen: That you would expect to have benefits in both?

Andrew Peters, Senior Vice President of Strategy, Exelixis: That’s the hope. Yeah. I mean, you know, if you look at the the stellar o o one data that we presented at ASCO GI, earlier this year, you know, that’s what drives a lot of my enthusiasm, drives a lot of our enthusiasm because you can see, again, three zero three is comparing the combination of tezozanza versus regorafenib. And so if you compare, you know, the the ITT data there as well as the data in the nonliver met group, we think that, you know, if those data hold up in three zero three, they certainly would compare favorably with what you would expect based on kind of historic rego outcomes. And so, you know, combination of all of those things.

Yaron Werber, TD Cowen biotech team, TD Cowen: Yeah. And then Stellar three zero five is the the go, no go based on the phase two portion in head and neck. This is Zanza with with Keytruda against Keytruda alone. The LENVIMA the LEAP 10 the LEAP 10 study failed. LENVIMA KEYTRUDA actually did worse than KEYTRUDA alone in the phase three, which was was a surprise relative to the phase two.

Yeah. I think that there’s a thought that it was because of tolerability. So why would ZENZAT be any better? Yeah.

Andrew Peters, Senior Vice President of Strategy, Exelixis: So I I I mean, I I think it’s a a good illustration of, you know, our approach in general. So, obviously, with 03/2003, we’ve made amendments to that study to, in our mind, increase the probability of success, including learning from other contemporaneous trials, like in the case of CRC, looking at the LEAP 17 results to understand some of those important dynamics around trial design. Similarly, with LEAP 10, so you mentioned that LENPEM actually showed a a detriment and was not a successful study. But importantly, it wasn’t a successful study on overall survival. The doublet actually showed pretty robust improvements not only on response rates, but PFS.

But those you know, the benefit that those patients saw was ultimately very, very short lived. And because of what we think are tolerability and toxicity issues, drove kind of that inversion of the the survival curve. So what we thought with 03/2005 was really to say, okay. We’ve generated really compelling data, we think, in a prior kind of smallish phase two IST with cabo and pembro. So clearly, a a patient population that we think is sensitive to a cabo like drug.

But can Zanza, which we envision, which we designed to be a more user friendly, more combinable, potentially, you know, more tolerable TKI, can those benefits that you see, their own response rate in PFS, actually translate to overall survival? Because if you look at the LEAP o one o data and you look at the discontinuation rate, what you really have are two groups of patients. Patients who discontinued, you know, the LEN arm. So on you know, depending on the the durability of the time on that doublet, what you’re really doing is you’re randomizing survival PEM versus PEM. And then the second group of patients discontinued both therapies due to tox.

And so, again, you’re having a group of patients which is functionally placebo versus PEM on a longer term kind of survival look. And so unsurprising if you’re seeing a lot of this heightened tolerability concern with lenvatinib, not necessarily translating to a survival benefit. And that’s something that unfortunately has been seen with a lot of the LEAP studies that that Merck has run over time. So really kind of the the question that we wanted to ask with Zanza is can that more combine a more more potentially user friendly, you know, potentially, you know, more tolerable TKI partner with pembro to drive survival in these patients. So that’s really the the the goal of the 03/2005 study.

Yaron Werber, TD Cowen biotech team, TD Cowen: And the phase two component, is that looking at o ORR and MDOR? What what drives the go, no go?

Andrew Peters, Senior Vice President of Strategy, Exelixis: So we actually haven’t broken out kind of what that, go, no go decision is based on obvious for obvious competitive reasons. But I think an important dynamic for you to consider and for investors to consider is that we’re actually not gonna see that data. So understandably, you know, as you imagine, in order for that phase two portion of the data to be used in the overall analysis, we don’t see it. We remain blinded to it. Because otherwise, if we saw that data, we’d essentially have to restart the phase three study.

And from a temporal perspective, again, that’s not super practical. And so we’re just gonna get a decision around is this study gonna get going to continue or not.

Yaron Werber, TD Cowen biotech team, TD Cowen: Yeah. And at that point, you’ll communicate it to us. I mean, presumably, it’s based on ORR and some kind of durability. I imagine it’s gonna be way too early to look at survival.

Andrew Peters, Senior Vice President of Strategy, Exelixis: We just haven’t said one way or the other.

Yaron Werber, TD Cowen biotech team, TD Cowen: Okay. So that that’s just a go, no go announcement, basically. Yeah. The okay. And then maybe I know we’re we’re running over now.

The, maybe a non CC RCC. I mean, that that trial design makes a lot of sense because cabo is on it is not formally approved. It’s on the NCCN guidelines. What’s

Andrew Peters, Senior Vice President of Strategy, Exelixis: the risk to

Yaron Werber, TD Cowen biotech team, TD Cowen: that study? I mean, that study really should work.

Andrew Peters, Senior Vice President of Strategy, Exelixis: Yeah. I mean, you know, the that’s the that’s the point of running these studies, so to speak, but it’s it’s one we’re particularly excited about. You know, one of the things that I’ve always found interesting is that there haven’t been, large randomized studies done in the nonclear cell population. It’s one of the reasons why we’re doing it actually. Utilization is really driven by a lot of kind of guidelines, based on, you know, single arm unrandomized data.

So what three zero four is is really an opportunity to define a new standard of care, in that nonclear cell segment of RCC. So, you know, we’re excited to share that data later this year. You know, obviously, it’s event based, so we’re kind of monitoring that real time, but, certainly something we’re looking forward to.

Yaron Werber, TD Cowen biotech team, TD Cowen: Yeah. And that second half. And then for going back to first line RCC, I mean, given that you have a collaboration with Merck, I mean, they’re not they’re not trying to salvage KEYTRUDA at this point. At some point, it will be biosimilar. They’re interested in Wellyreg.

You’re interested in combo, and you’re in the business of better outcomes for patients, right, as you say. The best outcome right now is nivo cabo, so that’s the control. So you potentially can go Keytruda, Zanza. That’s pretty that’s risky. But maybe doing a Welly reg, PEM, Cabo would make sense.

Anything I’m missing? Because that that it’s and someone feel.

Andrew Peters, Senior Vice President of Strategy, Exelixis: You know, again, so we’ve agreed with our partners Merck not to share additional details on the the ZANZA studies until they’re up and running later this year. So kinda stay tuned there. Certainly a lot to talk about, but we’ve just agreed with our partners to kinda keep that a little under wraps. Obviously, super competitive space. So, you know, wanna make sure that that those studies are up and running before we really kind of flush out a lot of those details.

Yaron Werber, TD Cowen biotech team, TD Cowen: Yep. Okay. The, and then maybe finally on, for the early pipeline, I know we’re we’re at 03:00, so maybe I’ll you have a lot going on in the early pipeline. Maybe is there one drug you wanna highlight to us really quickly in the phase one stages?

Andrew Peters, Senior Vice President of Strategy, Exelixis: Yeah. I mean, you know, we’re as we were talking about before this got started, kinda we’re on that pre ASCO reading up on anything phase, and, seems like bispecifics are the topic du jour. So six two eight is a is a program that recently went into the clinic, and I think I and and and a lot of folks have been surprised at the interest and enthusiasm for that program. So that’s a p d l one m k g two a bispecific that, in my mind, really reflects a kind of novel approach of taking two well understood mechanisms, combining them to really get that adaptive and innate immunity and kind of the same molecule. The biology behind it is super interesting.

And, you know, when we’ve talked with kind of these KOLs about it, that’s when you see kind of the lights going off in their eyes and their head around, oh, man. This really is kind of a something that’s different. And so, you know, ultimately, we’re in the business of p values as we like to say. This one’s in the very earliest stages of getting that going. But, you know, when I hear that, oh, this is different.

Oh, this is unique. I’m really excited about it. It’s something that I always internalize and, you know, think, okay. This is this is one that I like to talk about. But, you know, when they don’t have favorite kids, so to speak, ultimately, the data is gonna have to show which of those programs are gonna raise their hand, for us to, really invest and and run with.

Yaron Werber, TD Cowen biotech team, TD Cowen: And where where would that go? I mean, NKG two a, that’s been historically AML lymphoma. It’s been tested in autoimmunity. There’s a little bit of a gut excess too, at least on the on the

Andrew Peters, Senior Vice President of Strategy, Exelixis: I nine It’s really kind of a combination of of what I briefly mentioned before of, you know, how do you colocalize collocate the NK cells into the tumor microenvironment and solid tumors. So it’s not only kind of the activity of the PD L1 side, not only the activity of the NKG2A side, but kind of that colocalization dynamic of the bispecific and how do you form that trimer? Can you form that trimer of kind of the tumor cell and the NK cell? And, you know, that’s something that I think is is unique. We had some data, earlier this year on that, that that that I think you should check out.

But it’s it’s really about some of that novel biology. And, you know, as I mentioned before, as we head into ASCO, bispecifics are certainly on top of a lot of people’s minds, so kind of making sure that, you know, people are aware of that that program.

Yaron Werber, TD Cowen biotech team, TD Cowen: Yeah. Well, terrific, Andrew. Always great to see you. We’re

Andrew Peters, Senior Vice President of Strategy, Exelixis: over Good to see you.

Yaron Werber, TD Cowen biotech team, TD Cowen: I appreciate it, and we’ll see you soon.

Andrew Peters, Senior Vice President of Strategy, Exelixis: Flying out to Chicago, and I’m sure I’ll

Yaron Werber, TD Cowen biotech team, TD Cowen: see you around. I’ll see you there at the airport as usual. Yeah. Alright. Bye.

Thank you.

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