Arcus Biosciences at Barclays Conference: Strategic Pipeline Insights

Arcus Biosciences (NYSE: RCUS) presented its strategic pipeline updates at the Barclays 27th Annual Global Healthcare Conference on Thursday, 13 March 2025. The company, led by CEO Terry Rosen and COO Jennifer Jarrett, highlighted promising developments in its clinical trials and strategic positioning, while addressing concerns about tariffs and FDA interactions, which were deemed non-impactful.

Key Takeaways

• Arcus is advancing its HIF2 alpha inhibitor program, with data from the ARK20 study expected over the next two years.
• The PEAK1 Phase 3 study will compare casdatofan plus cabozantinib against cabozantinib alone.
• Arcus collaborates with AstraZeneca on a study combining casdatofan with a PD-1/CTLA-4 bispecific.
• The STAR-221 trial for upper GI cancers is fully enrolled, with OS data anticipated in the fall.
• The CD73 program in pancreatic cancer is progressing rapidly, with a potential readout by 2026.

Operational Updates

• Supply Chain: No significant impact anticipated from tariffs.
• FDA Interactions: Ongoing interactions with no changes observed.
• Clinical Trial Enrollment: Enrollments are progressing well without issues.
• PEAK1 Study: Scheduled to start by mid-year, focusing on safety and efficacy.
• AstraZeneca Collaboration: Focus on safety in combining casdatofan with AstraZeneca’s bispecific.
• STAR-221 Trial: Enrolled 1,047 patients, with data expected in the fall.
• CD73 Program: Phase 3 trial in pancreatic cancer is advancing quickly.

Future Outlook

• HIF2 Alpha Program: Consistent data flow expected from the ARK20 study.
• PEAK1 Study: Aiming for rapid data acquisition due to the PFS endpoint.
• TIGIT Program: Anticipates positive OS data from the STAR-221 trial.
• Strategic Positioning: Casdatofan is positioned as a superior HIF2 alpha inhibitor compared to Merck’s belzutifan.

Q&A Highlights

• HIF2 Alpha Program: Mid-year data will focus on the CAST plus cabozantinib cohort.
• Dosing Strategy: Confident with the 100 mg QD dose of casdatofan.
• Combination Therapy: Expected improvements in response duration and rates.
• Prior Use: Not targeting patients with previous HIF2 alpha inhibitor use.

For more detailed insights, refer to the full transcript below.

Full transcript - Barclays 27th Annual Global Healthcare Conference:

Peter Lawson, Biotech Analyst, Barclays: My name is Peter Lawson. I’m one of the biotech analysts at Barclays.

I had the pleasure for the last five years or so covering Arcus Biosciences. And up on stage with me, I’ve got Terry Rosen, CEO and Jennifer Jarrett, the Chief Operating Officer. And I’ll be moderating the Q and A. I’ve been asking our companies kind of just on the macro level, any impact you’re worried about anticipating from tariffs on the supply chain? And I guess drawing back to COVID, I guess that helped insulate the company as well.

Terry Rosen, CEO, Arcus Biosciences: Yes. No. So far, keeping a close eye on everything. And as you know, like by the day, it’s sort of a moving target. But right now, we’re not anticipating anything major that would be an impact from the tariffs.

Peter Lawson, Biotech Analyst, Barclays: Got you. And then FDA interactions, have there been any changes?

Terry Rosen, CEO, Arcus Biosciences: No, not at all. Zero. So maybe they’re letting people go in other areas or withholding funding in other areas. But we haven’t seen we’re having a lot of ongoing interactions with the FDA as we speak and have seen zero impact.

Peter Lawson, Biotech Analyst, Barclays: No kind of income in resumes from the FDA or NAH? Yes.

Terry Rosen, CEO, Arcus Biosciences: That’s a regulatory team, but no, not that I’ve seen, yes.

Peter Lawson, Biotech Analyst, Barclays: Okay. And then NAH spend, I know that’s kind of a essentially a very large negative if you think about it longer term, but anything near term that could like trickle through to clinical trials?

Terry Rosen, CEO, Arcus Biosciences: No, I don’t remember. Yes. I mean, we’re not working with NIH or whatever. Everything that we’re doing is with institutional sites. So we expect zero impact from anything that might be happening a lot.

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: Honestly, our trial enrollments across the board is going quite well. Okay. It’s nothing we anticipate.

Peter Lawson, Biotech Analyst, Barclays: Okay. Perfect. And then I guess if we think about your pipeline, HIF2 alpha, I guess combination data in the middle of this year, what should we expect from that? How much follow-up data should we see?

Terry Rosen, CEO, Arcus Biosciences: Yes. So, what’s nice about how the ARK20 study has been designed is there’s a lot of different cohorts and we’re looking at a lot of different things within that study. And so as a result of that, there should be a very steady flow of data really over the next two years. And so the next data set that we’ve been talking about presenting will be around mid year. And so that’ll be the first look at the cohort that’s evaluating CAST plus cabozantinib.

It will probably include efficacy data on around 25 patients. The safety database will probably be a little bit bigger, just because I think on the efficacy side, we’ll probably focus on patients that have had a certain number of scans, but we want to give people as broad a look at the safety as possible because we know that that’s important to people. And so far the safety is looking really good. Later in the year, we expect to present more mature data from the monotherapy cohort that were the original cohort that were enrolled as part of ART20. And then as we go into next year, we should have more mature data from the CAST CABO cohort.

Maybe even later this year, we have some more mature data from that cohort. And then we’ve added some new cohorts to ART20. And so next year, we would actually start to generate some data from those other cohorts as well. But back to this year, as I said, the two data sets to focus on will be the one around midyear for CAST cabo and then later in the year for CAST mono where we’ll have more mature data and maybe we’ll have PFS from the fifty mg QD cohort at that time.

Peter Lawson, Biotech Analyst, Barclays: Got you. And so that’s the key thing you think to focus on for the combo data is with a PFS or

Terry Rosen, CEO, Arcus Biosciences: the data? The more mature ORR. So as we’ve seen like ORR can increase over time, responses can happen late with this mechanism. So it will be more mature ORR and then PFS for the cohort that we do not have mature PFS for at the ASCO GU presentation.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay. Thank you.

Terry Rosen, CEO, Arcus Biosciences: To the extent we’ve hit a median, yes, we still have not hit a median for the fifty mg QD or for the one hundred mg QD.

Peter Lawson, Biotech Analyst, Barclays: Right. Perfect. That kind of brings me on to the next question just about the I guess, the current CAS level, like what one hundred milligram dose in the combination? Is there any need or desire to push it higher or bring it down? Or kind of how should we think about that dose going forward?

Terry Rosen, CEO, Arcus Biosciences: Yes. We’re very, very comfortable with one hundred mg QD dose. We’ve talked about that with the FDA. We had our meeting with them last year. They were comfortable with that dose.

We’re starting to see some data from the one hundred and fifty mg monotherapy cohort. There’s nothing in that dataset that would tell us that we should be going with a higher dose. And as we’ve been saying, we think fifty mg QT is getting towards the top of the dose response curve and the flat part of the dose response curve. But we probably are squeezing a bit more efficacy out of the one hundred mg QT dose. But we don’t think we’re going to get a whole lot going to one hundred and fifty mg.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay. And then in the combo versus the mono, what does that do? What is the what’s the benefit? Is it response rates?

Is it duration?

Terry Rosen, CEO, Arcus Biosciences: Yes. It’s going to be all of those things. I mean, duration response is something the response for this mechanism is so long that that’s something I don’t think we’re going to know for a while, but we do expect to see an improvement in duration of response. As we said, just going back to the monotherapy expansion cohorts, when we presented that data, we had 26 responders across the three cohorts, only two of those responders had progressed. So, duration of responses for CAF mono and CAF cabo is going to be incredibly long.

But we do expect to show improvement on the other measurements, you mentioned ORR and PFS. ORR would obviously be the most nurturing ones that we’d be able to demonstrate. PFS will take a while to mature, but we do expect to show improvement on both those metrics and then ultimately overall survival.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay. Do you have a goal in mind for the improvement around ORR or DCR or prevention of

Terry Rosen, CEO, Arcus Biosciences: Yes. I think I mean, yes, so I just have to quantify improvement, but I think what we’ve been saying very consistently is that CAB CABO ORR will be higher than what we’ve seen with CAST mono as well as what’s been seen for CABO mono. And there’s a few different studies out there. And so that is our goal to show that we can get to a higher response rate versus both agents as monotherapy. And I think when you see the waterfall chart and other graphs, I think it will show clearly that there’s something more happening there than you would expect with either mechanism alone.

Peter Lawson, Biotech Analyst, Barclays: Okay. So at the moment, you’re not kind of guiding to a success rate for the O?

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: No. And I think the way you should think about our Cas Cabo data, it’s going to be early. But the most important thing is that you will look at those data and be able to look and say like they’re going to be running a trial of CATs cabo versus cabo. It’s going to look like you will believe that they’re going to that trial is going to be successful and it’s going to be clinically meaningful difference. And I think the data will already be telling that story.

Peter Lawson, Biotech Analyst, Barclays: Okay. Got you. Thank you. And then have you seen and where we see, I guess, patients that have had prior HIF2 alpha?

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: No, that’s easy. We’re not looking at patients that have had prior HIF2 alpha inhibitors. Okay. As a matter of fact, the patient population really doesn’t exist. You’re not seeing patients getting the approval for belzutifan is in late line patients.

So obviously, you won’t be having patients coming into this that have had HIF2 inhibitor. And it’s not even a sort of a feasible thing at this point.

Peter Lawson, Biotech Analyst, Barclays: Yes. Would you assume that too similar to if you’re not responding to HIF2 alpha, it would just be

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: So in general, we would feel that way. However, if you think hard about it given now I’m talking more downstream, you could imagine since we’re seeing that dramatic difference in the rate of primary progression, we see about half the rate versus balsutufin. What that tells you if that’s true that means that those fifty percent that are progressing on belzutifan that might not have otherwise were not intrinsically resistant to the HIF2 alpha mechanism. So you could imagine at some point a study where you would look at, for example, those early progressors and that that would not have represented some sort of resistance generation. And so you could imagine those patients going on to casratofan after belzutafan and there might be some benefit there, but that’s not in our near term plans.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay, perfect. Thank you. And then, so the data in the full, the additional monotherapy, I think we touched upon it, but kind of what should we expect to be seeing from that? I know there’s a couple of doses that we should be thinking about.

And does that data in any way change the registration strategy?

Terry Rosen, CEO, Arcus Biosciences: No. So you mean anything that we see in the monotherapy or cath copy? Yes. No. I mean, we’re obviously looking at the data on a regular basis.

I mean, there’s nothing that we’ve seen that would change our registrational strategy. And as a reminder, our first registrational study is a study called PEAK1, where we’ll be looking at CAS plus cabozantinib versus cabo. So that’s why that cabo cohort is so important. As Terry was saying, first of all, obviously, we want to look at safety and and make sure that we can combine those two mechanisms safely, which so far based on everything we’re seeing we can. And then obviously, you don’t want to start to look at efficacy as the data set matures.

But we’re super excited about the study. It’s very simple study about as simple as you get. 700 patients, PFS endpoints. We really set up the study so that it will enroll well and enroll quickly. As an example, we’re using two:one randomization.

So patients have twice the likelihood of getting in the experimental arm versus the control arm, which is something both patients and clinicians like. We don’t see a lot of competition out there, direct competition for patients in the study. That’s something that our investigators have been pointing to as well and why they’re really excited about the study and why they think the study is going to enroll quickly. And then obviously the fact that it’s a PFS endpoint should allow us versus overall survival will allow us to get to an answer pretty quickly as well. So, So far, I’m not seeing anything in the data that would make us change our plans and we’re as excited as ever about getting the study started and expect it started by mid year.

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: So to your specific question about the data sets, the monotherapy data sets that we’ll show later in the year, I think they will have, as Jen said, zero impact on registrational strategy. I think the only thing they’ll do is reinforce confidence that ketradifan looks both better than belzutifan and looks better than TKI monotherapy because what you’ll see is more mature data from those earlier cohorts. We’ll see deepening of responses. You’ll see actual where we had PFS that was immature or we couldn’t even state a medium PFS. PFS that’s likely to be double or more than that of what’s been reported for bilsudefan.

So it’ll just be confidence enhancing probably more to the external world than to ourselves or investigators, but nothing that will change any of our strategy.

Peter Lawson, Biotech Analyst, Barclays: Got you. Thank you. And then on the safety, what should we be looking for? What’s the worry? I mean, I guess, cover has been a fantastic drug, but it’s sometimes difficult to take just Yes.

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: I think there’s actually, the data will end up showing what was anticipated, but you need to play the game to know the outcome. And there are orthogonal mechanisms of any substantial AEs that you see from casadaptafen like dalzutapan are those that are on target anemia and more rarely hypoxia. And when you combine the two mechanisms, there doesn’t seem to be anything that ends up being some sort of synergistic tox. And as a matter of fact, we’ve been looking at the clinically used dose of CABO in combination with the one hundred milligram dose of castatapine and that seems to be quite good.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay. Perfect. Thank you. And just on to PEAK1, you’ve touched upon it.

Just how should we think about interim data? And kind of if it’s built in, what triggers it and what should we expect to be seeing for that interim?

Terry Rosen, CEO, Arcus Biosciences: Yes. We haven’t really talked about the statistical analysis plan and whether look and for competitive reasons and all sorts of reasons we probably won’t. But like I said, I think the important point is it is a PFS primary endpoint. All of the alpha is on PFS. And if you look at what cabo alone has done on PFS, it’s been about ten months and you’ve done a good job, I think, of of pulling together that data.

And actually the range has probably been about 7.5 to ten months. The METEOR was about seven point five months. Cosmic three zero three was I’m sorry, CONTACT three zero three was ten months. And so that’s the range that we’d expect for the control arm. So not a huge amount of time.

And that again is why we think we can get to data relatively quickly.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay. Perfect. And what else? Oh, and I guess the antiseetalate four PD-one combination as well, kind of when do we see that data?

And I guess what should we be looking for? It’s an interesting combination.

Terry Rosen, CEO, Arcus Biosciences: Yes. So the study that you’re referring to is part of the clinical collaboration between us and AstraZeneca where we’re combining CAS with their PD-one CTLA-four bispecific. They presented data on their molecule about a year and a half ago now at ESN RCC, which looked very, very interesting. We work with their same investigators. Investigators are very excited about that molecule.

So we are combining BOLRU with CAS as part of a study that they will be operationalizing. We haven’t talked about the economics of this study. But obviously there’s some cost sharing, so it’s a really efficient way for us to be exploring that combination. In that combination, we’ll be targeting patients that are IO naive, which are essentially going to be first line patients. So that study will start right around the same time as PEAK1.

The focus for this study will really be on safety, just again similar to what we’re doing with Cascabo right now, just just to make sure that those two mechanisms can be safely combined. We don’t expect there to be any overlapping toxicities again like CAST CABO. And so we expect very much that those mechanisms will be safely combined. And I think we’ll talk more in the future about what we want to do next. And I think around midyear, we’ll be able to say more about the study for competitive reasons.

We’ve been pretty quiet. That says AZ about what we’re planning. But like I said, when we’re getting the study off the ground, I think we’ll be able to say a lot more exactly what our strategy is with that program and in that setting.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay. And being several years behind Merck, how do you what’s the go to market strategy? It’s like having the right combinations, it’s just having a better molecule?

Terry Rosen, CEO, Arcus Biosciences: It’s all of that. I think like early on, we would tell people including you like even if our molecule looks just like those, we think we have a differentiated development strategy and differentiated combination partners. And we still very much believe that I think the thing that has changed as we generated more and more data from R20 is we are very, very confident now as I think the investigator community that we have a better HIF2alpha inhibitor. And I think Terry touched upon the efficacy data that we’ve seen, but we’re seeing half the rate of primary progressive disease. They’ve seen ORRs kind of ranging from eighteen percent to twenty one percent.

We’re now clearly north of thirty percent. Our PFS is much longer than what’s been seen with belbutafan. So we have a better backbone, hip two alpha inhibitor molecule. And then we are also evaluating combinations that we think are going to be better than what Merck is doing. As an example, they are combining Bells with lenva, which is their TKI.

The challenge with LEMBA is that it’s a more toxic TKI. So I think it’s going to be more difficult to combine with relative to cabo, which we’re combining with. The other challenge with lambatimab is that it’s a lot more difficult and complicated to dose. It’s available at a lot of different dosing regimens. So when you talk to investigators about like your experience with lemba, they would just tell you that just the titration up and down is a lot more complicated than with cabo or cabo is available three dosage four and twenty, forty, sixty that’s it.

So we think we have a better TKI combo study. The other challenge with their study is they are combining with lambo, but they’re using cabo in the control arm. So if Lenda underperforms cabo that could create some issues for them in that study. And then just the last point that I’d mentioned, our first line strategies are just completely different. They are combining with PD-one and TKI.

We’re combining with PD-one and CTLA-four. So we’re just going after different segments of the market and we’re competing, but with different combinations in the first line setting. And again, because ours is TKI free, we think we have a better combination.

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: I think the way you should think about that because we get to ask that question a lot and I think it’s not a situation like based in actual reality. So Jen talked about the difference in strategy, but the reality is Merck is ahead on one study, LENVA. And that study may or may not even be successful and it’s obviously the readout has been pushed out since it was initially reported. We get asked sometimes, oh, but they’re combining with ZANZZA, how is that going to be? That will actually end up being behind us.

So we have what’s clearly emerging is a better molecule and then not only are our strategies differentiated, Jen said they’re not even going right now with the TKI sparing regimen which we see is the direction that the field is going to go. As I was mentioning before, we see that casdatafan is looking even better than TKI monotherapy. So we see a paradigm shift where HIF2 alpha will be going earlier in the treatment paradigm with potentially the TKI being put off till later so patients can avoid the TKI. But we don’t even really see ourselves as substantially behind Merck in general other than in that single study.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay. Perfect. Thank you. And then, TIGIT, so the gastric data and kind of expectations, can you help us set expectations around the OS for the fall of this year?

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: Sure. So we let me remind everybody, we’re looking at our registrational studies called STAR221. It’s an upper GI cancers. Straightforward trial. It’s a Damsim chemo versus Nivo chemo.

Nivo chemo is the standard of care. We reported a median PFS some time ago of around twelve to thirteen months. That’s actually the equivalent of the OS for the standard of care and we’ll have data later in the fall that will where we will share the OS. We have said publicly that with eighteen months of follow-up, we had well over fifty percent of the patients still on study. So we think that’s going to look quite positive for the standard of care there.

There’s in addition to nivo chemo, there’s also KEYTRUDA chemo is approved and Tisley chemo approved very similar thirteen ish month OS. So we think we have opportunity to very substantially beat that in a very clinically meaningful way. But more importantly, the Phase three study that’s correlative to that STAR-two twenty one was fully enrolled as of June of last year with ten forty seven patients. So it’s a very well quality. So you can do the math and by the end of this year it will be eighteen months since the last patient was in.

And so with the standard of care of twelve or so months

Peter Lawson, Biotech Analyst, Barclays: you

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: can get a sense as to that readout. We’ve got we’ve been guiding to a 2026 readout and we’ll probably give tighter guidance as the year goes along.

Peter Lawson, Biotech Analyst, Barclays: Got you. And that trial

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: over

Peter Lawson, Biotech Analyst, Barclays: enrolled and does that kind of help with the stats or?

Terry Rosen, CEO, Arcus Biosciences: Yes. It did over enroll as one of those that was enrolling. It seems like 100 patients maybe more than that.

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: Fifteen months.

Terry Rosen, CEO, Arcus Biosciences: A month towards the end. So it was almost impossible to not over enroll because you can’t just all of a sudden stop and all the slots go away. Yes, so it did enroll, which is obviously a good thing because it gives us a bit more power as well in the study. But the over enrollment was a function of just how quickly it was enrolling at the end.

Peter Lawson, Biotech Analyst, Barclays: How are you thinking about kind of the probability of success in intent to treat versus the PD L1 high population?

Terry Rosen, CEO, Arcus Biosciences: Yes. So, again, without going to the stats plan, it’s probably a little bit difficult to give you a specific answer, but I think we’re very optimistic on both. I think when we look at the EDGE gastric data, which obviously includes the ITT patient population and we’ve been looking at different cuts of the data, I think we’re still optimistic that obviously very optimistic on PD L1 high, but also pretty optimistic on ITT. If it were to hit just in PD L1 high and to be honest, I think we’re thinking about it more about PD L1 positive versus PD L1 high. And so we actually changed the stat plan a bit where we’ll initially just like we were, we’ll look at PD L1 greater than five and then ITT is dual primary endpoint.

But if you hit on one of those endpoints, there’s been a hierarchical analysis and we’ll look at PD L1 greater than one. So if we do have a situation where we didn’t hit an ITT for some reason, but we do hit on PD L1 greater than five, you then have a really good opportunity to expand the label to PD L1 greater than one, which is eighty percent of the patient population. So as a reminder, the allocation across the PD L1 positivity is different than what you see in lung and it’s very weighted towards PD L1 greater than one. But all that said, we’re still very optimistic about ITT and we’ll see the data actually pretty soon.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay. And what would you have to do so if you didn’t hit, would you have to do PD L1 testing or?

Terry Rosen, CEO, Arcus Biosciences: Regardless, there’s going to be PD L1 testing. I mean, just like today, I mean, every we’ve been doing actually a lot of work on this, but almost everybody is tested for PD L1 just like lung and gastric today. So irrespective of what happens, like patients will likely be tested before they receive some common

Peter Lawson, Biotech Analyst, Barclays: And then there are no complexes around the testing as sometimes we see with lung or

Terry Rosen, CEO, Arcus Biosciences: No, no. It’s like it’s a very routine testing that everybody is doing now.

Peter Lawson, Biotech Analyst, Barclays: Got you. Okay. And then what are the expectations around the control arm for T21? Really

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: sort of straightforward because it’s been so consistent. So, the nivo chemo comes in about thirteen months OS and similarly it comes in around seven months PFS, even though PFS isn’t fee, the readout and as I mentioned before, Tisley chemo and KEYTRUDA chemo also are in that thirteen month range. So it’s very clear, very consistent standard there.

Peter Lawson, Biotech Analyst, Barclays: And then maybe in the last few seconds, just on CD73 kind of what should we expect like the translation of that Phase I into Phase III, any differences in the trial and have

Jennifer Jarrett, Chief Operating Officer, Arcus Biosciences: we been We think that’s a great trial. So that’s a little under the radar, but it’s a Phase III trial in pancreatic frontline pancreatic cancer. It’s off to an incredibly quick start. Enrollment is great. I think it’s very realistic that it could be enrolled even within a year and certainly a readout in 2026.

Simple design going on top of standard of care, gemabraxane versus gemabraxane, quemly, very similar to what we did previously and we think supported very well by a synthetic control arm that we had done in parallel to the initial trial as well as biomarker work that actually suggested we were doing better in patients that from a prognostic standpoint actually should have done worse, but those patients that have high adenosine. So we feel A, very optimistic about the reproducibility of those earlier results and B, that we’ll have those data very near term.

Peter Lawson, Biotech Analyst, Barclays: Perfect. Thank you so much. Thank you. It was a pleasure, Jin.

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