Q2 2023 Immunocore Holdings PLC Earnings Call

Participants

Bahija Jallal; CEO & Director; Immunocore Holdings plc

Brian R. Di Donato; CFO & Head of Strategy; Immunocore Holdings plc

Clayton Robertson; Head of IR; Immunocore Holdings plc

David Berman; Head of Research & Development; Immunocore Holdings plc

Mohammed Dar; Head of Clinical Development & Chief Medical Officer; Immunocore Holdings plc

Ralph Torbay; Head of Commercial; Immunocore Holdings plc

Ahu Demir; MD & Senior Research Analyst; Ladenburg Thalmann & Co. Inc., Research Division

Gil Joseph Blum; Senior Analyst; Needham & Company, LLC, Research Division

Graig C. Suvannavejh; MD and Senior Biopharmaceuticals & Biotechnology Equity Research Analyst; Mizuho Securities USA LLC, Research Division

Jeff Hung; Equity Analyst; Morgan Stanley, Research Division

Justin Alexander Kim; Associate; Oppenheimer & Co. Inc., Research Division

Justin Reid Zelin; Director & Biotechnology Research Analyst; BTIG, LLC, Research Division

Michael Jonathan Yee; Equity Analyst; Jefferies LLC, Research Division

Michael Werner Schmidt; Senior Analyst & Senior MD; Guggenheim Securities, LLC, Research Division

Patrick Ralph Trucchio; MD of Equity Research & Senior Healthcare Analyst; H.C. Wainwright & Co, LLC, Research Division

Tyler Martin Van Buren; MD & Senior Equity Research Analyst; TD Cowen, Research Division

Unidentified Analyst

Presentation

Operator

Greetings. Welcome to the Immunocore Second Quarter 2023 Financial Results and Business Update Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. At this time, I would like to hand the call over to Clayton Robertson, Head of Investor Relations. Thank you. You may begin.

Clayton Robertson

Thank you. During today's call, we'll be making certain forward-looking statements, including about financial projections, development activities, business strategy and the timing and impact of future events. Actual results could differ materially from those projected by these statements, which are based on management's views as of today and subject to risks and uncertainties, including those noted in our most recent Form 20-F and any 6-Ks we filed with the SEC in the earnings press release we issued this morning. You're cautioned not to place undue reliance on these statements, and Immunocore disclaims any obligation to update them. We will also disclose certain non-IFRS measures on today's call, which are reconciled to comparable IFRS measures in today's slides. I will now hand over the call to our CEO, Dr. Bahija Jallal.

Bahija Jallal

Thank you, Clay. Good morning, and good afternoon. Welcome, everyone. I am here today with Brian Di Donato, our CFO; Ralph Torbay, Head of Commercial; David Berman, our Head of R&D; and Mohammed Dar, our CMO. We will answer your questions after my closing remarks. During this call, we will share an overview of our second quarter and first half of the year performance as we continue to deliver our mission to radically improve outcomes for patients with cancer, infectious disease and autoimmune diseases. I am proud to report that we have delivered another excellent quarter of performance, both commercially and in terms of progress with our pipeline.
In the first half of the year, KIMMTRAK revenue was $111 million. That growth reflects a robust commercial execution and the recognized benefit that KIMMTRAK provides to patients. Now approved in over 35 countries, KIMMTRAK has recently launched in 4 additional countries. Ralph will share some insights on the Q2 commercial execution and the growth drivers for the second half of the year. Disciplined expansion, expense management and our strong cash position allows us to continue to advance and invest in the pipeline in Oncology and Infectious Diseases and we are thrilled to announce that we will start the first Phase III randomized trial with our PRAME-targeted ImmTAC.
David will walk you through the trial design today and provide an update on the durability from the melanoma patients we presented at ESMO last year. And we have continued to treat patients in the PRAME Phase I monotherapy and combination cohorts with plans to present data in the first half of next year. We are also randomizing patients in the Phase II/III late-line cutaneous melanoma trial with KIMMTRAK. The expansion of our Oncology pipeline continues as our teams are working on IND or CTA application for 3 new products with PIWIL on track for IND by year's end. And finally, trials with our Infectious Disease candidate investigating the potential for functional cure for people living with HIV and HBV are ongoing and enrolling patients as we speak. I will now hand over to Brian.

Brian R. Di Donato

Thank you, Bahija. Good morning, everyone. Earlier today, we released our financial results for the second quarter ending June 30. I invite you to review the release and our SEC filings for more details. I'll share some of the key highlights.
On Slide 7, you'll see the summary of our financial results. I'm delighted to report that our teams have delivered another impressive quarter of KIMMTRAK sales. Net KIMMTRAK revenue grew to $57.8 million in Q2 from $52 million in Q1, primarily driven by growth in the United States. We have now launched with reimbursement in 7 countries, including Italy. I am pleased to announce that we have reached a reimbursement agreement with Germany, which is slightly improved from our accounting assumptions.
We expect Germany to publish the price in September. Ralph will take you through the launch details. Both R&D and SG&A expenses for the quarter were broadly flat with Q1 with a net loss for the period of approximately $18 million. Year-to-date, SG&A expense includes approximately $12 million of currency mark-to-market and $14 million of noncash share-based payment expenses, so in total, $26 million. For a net cash year-to-date SG&A expense of roughly $60 million.
Looking ahead, we expect R&D expense to increase gradually over time as we expand our PRAME investment, including the new Phase III melanoma trial announced today. Our cash position of $435 million has continued to increase over the past 3 quarters, driven by KIMMTRAK revenue, U.K. tax credits and disciplined expense management. With that, I'd like to congratulate the teams on another great quarter, and I'll turn the call over to Ralph, who will review the KIMMTRAK commercial performance.

Ralph Torbay

Thank you, Brian, and hello, everyone. KIMMTRAK is approved in over 35 countries, and we have launched in 4 additional markets this year, including Italy, Austria, Finland and Israel. With U.S., Germany and France, we estimate these 7 markets represent 3/4 of KIMMTRAK's global potential sales. In Q2, we had our strongest revenue quarter to date with $57.8 million in net sales, up 11% quarter-over-quarter. Importantly, this represents the fifth quarter of growth.
Next slide, please. There are 3 factors underpinning our growth this quarter. First, we saw 14% demand growth in the U.S. where we increased our first-line market share from around 50% in Q1 to 60% in Q2. The second driver of growth is that patients are appropriately remaining on therapy. This is the result of our focus on educating healthcare professionals around the importance of continuing treatment in the presence of clinical benefit.
Lastly, in Europe, nearly all first-line patients in Germany and France received KIMMTRAK. We have seen incremental growth driven by our new launches, including Italy, where the team transitioned all patients to reimburse KIMMTRAK in a record 3 months. Looking ahead, in the second half of the year, we see 2 significant revenue drivers for KIMMTRAK. In the U.S. we expect further growth from our continued educational push into the community while supporting patients on therapy. KIMMTRAK's 3-year overall survival data expected later this year will be instrumental in achieving this goal. We also expect to grow Italy and continue to launch in several additional European countries by the end of the year.
Let's move on to reimbursement updates. As we shared with you in the July 6-K, the CMS in its draft rule, named KIMMTRAK as meeting a unique circumstance for an increased exemption threshold. If this language is maintained in the final rule, expected in Q4, it would functionally exempt KIMMTRAK from a refund. In Germany, we successfully completed price negotiations and the agreed price will be published in September.
We're pleased with the outcome, which is not materially higher than our accruals to date. The price remains confidential until publication. In the U.K., we expect reimbursement discussions will continue well into 2024. It has become, unfortunately, more common for innovative products to receive a negative funding decision from NICE and the process to be extended. In France, we're confident going into reimbursement negotiations with KIMMTRAK having had a strong ASMR III rating from the Commission de transparence and plan to have an updated agreement in place in 2024.
So to sum up, I'm delighted with our continued progress in the second quarter, and we remain firmly committed to our mission of making KIMMTRAK available to over 1,000 patients per year by 2025. I'd now like to pass the call to David to walk you through our exciting R&D plans.

David Berman

Thank you very much, Ralph. We continue to make good progress in our Oncology and Infectious Disease clinical pipeline. And today, I'm going to focus on 2 programs. First, I'm going to share recently published KIMMTRAK data, which we believe provide insights for how we will develop PRAME. And second, I'm going to update you on PRAME including the original 18 melanoma patients from ESMO, and I'm very proud to also introduce our new Phase III study in first-line cutaneous melanoma. We presented the Phase III first-line ctDNA data for KIMMTRAK result at AACR earlier this year. And there are 2 points that I take from these data. First, a majority of patients are benefiting from KIMMTRAK since most patients are having ctDNA reduction. And second, KIMMTRAK has higher activity in first line compared to second line based on the threefold higher rate of ctDNA clearance. This informs for our platform, including PRAME that where possible, we should strive to move to earlier lines of therapy. Also at AACR, we presented that KIMMTRAK, at 3 years, has long-term survival benefit in second-line uveal melanoma compared to historical controls.
We have been following these patients to look for a long-term survival tail since this is the hallmark of other I-O therapies such as (inaudible). These data are very encouraging, and we will share the 3-year survival update from the first-line Phase III study later this year. The emergence of the long-term survival benefit, however, increases our confidence that this platform can be transformative to patients and we hope to extend with PRAME to other tumors.
Turning to cutaneous melanoma. We recently published the final results for KIMMTRAK plus checkpoint combinations. Most of the data has previously been shared. However, there are several insights I would like to emphasize. First, the durability of partial responses and disease control for this combination is remarkable with some ongoing for over 2 years. This increases our interest to study PRAME plus checkpoints. Second, the safety profile was consistent with each therapy alone providing confidence for combining PRAME safely with checkpoints. And finally, we have historically dosed ImmTAC's monotherapy on a weekly basis.
However, we had hypothesized that we can switch to less frequent dosing when impacts are combined on a backbone of an active therapy and after initial disease control. In this study, we successfully piloted switching from weekly to monthly KIMMTRAK 1 year with most of these patients maintaining their disease control. This provides confidence for doing similar with PRAME. These are some of the many insights we are applying to the PRAME program.
At ESMO '22, we shared the initial PRAME monotherapy Phase I data that led to the expansions in melanoma, lung, endometrial and ovarian carcinoma as a monotherapy in heavily pretreated patients and in combination with standards of care since this will allow us to move into early lines of therapy. We always anticipated to see signals earlier in some tumors that would provide confidence to start registrational trials. And today, I am very pleased to announce our first Phase III registrational trial, PRISM 301 in first-line cutaneous melanoma.
Here is the ESMO melanoma data we shared last year, which included 18 melanoma patients, 7 cutaneous melanoma all had prior ipilimumab and either nivolumab or pembrolizumab and 11 uveal melanoma patients, roughly half of which were to tebentafusp naive and have had prior tebentafusp. Here is an update on those original 18 melanoma patients. We continue to see strong durability, including partial responses ranging from 6 to 17 months. Even in some patients whose tumor shrinkage did not meet the criteria for a RECIST partial response, we see durable disease control. Some of these patients are still on therapy.
The cutaneous melanoma activity is remarkable to me given these patients are heavily pretreated, and the fact that F106C is being administered as a monotherapy. As a monotherapy, the durable responses and disease control from F106C in melanoma were clearly compelling. This, coupled with the well-tolerated safety profile, our belief in combinability with checkpoints and the insights that our platform will work best in a first-line setting led us to consider opening a Phase III first-line melanoma trial with the primary endpoint of progression-free survival.
In addition to the original 18 patients, the emerging data from the newly enrolled cutaneous melanoma patients, which although has less follow-up, increases our conviction to start the Phase III trial now. Finally, the platform insights into how we can design a more patient-friendly and less frequent dosing regimen in first-line solidified our decision to move forward. We had a successful Type B meeting with the FDA who agreed to the Phase III design and for us to start the study now, and I will walk you through that study design.
PRISM-MEL301 was designed with help from global melanoma experts and input from the FDA. We will randomize previously untreated metastatic cutaneous melanoma patients who are HLA-A*0201 positive in two arms, the experimental arm, nivolumab plus F106C versus a control arm of either nivolumab or nivolumab plus relatlimab. The selection of therapy within the control arm will be country specific and will not be investigator choice. This is the first Phase III trial we are aware of to randomize to a control arm that includes checkpoint doublet.
The primary endpoint is progression-free survival and the secondary end point are survival and response rate. The F106C regimen, shown on the slide reflects a growing confidence on how to dose ImmTACs when in combination with an active backbone. Because we had multiple doses that were clinically active and well tolerated, we agreed with the FDA to include an initial randomization to 2 F106C doses, 40 micrograms and 160 micrograms. This approach is consistent with FDA's Project Optimus. We will drop one of the two F106C doses after an initial interim analysis. But importantly, there is no pause in their recruitment and all patients in the go-forward dose are included in the intent-to-treat analysis.
This is a really exciting time for us at Immunocore. The PRISM-MEL301 study represents the first Phase III study for the PRAME target and for a TCR therapeutic in first-line cutaneous melanoma, which is one of the largest melanoma indications, an opportunity of over 10,000 patients per year. The Phase I/II Study 101 is still enrolling the 4 monotherapy expansions at the 160-microgram dose. And we continue to look at the other tumors, lung, ovarian and endometrial for the next tumor for development.
For the Project Optimus FDA discussions, we will also enroll some more patients with the same tumor types in the 40-microgram cohort, which will serve to help confirm the dose. The combinations with standard of care are also progressing and these will provide safety that will allow us to move into the early lines where we believe our platform will be most active. Finally, based on our excitement for PRAME, we are building a franchise around this target with our half-life extension and our PRAME A24 programs on track for regulatory submissions next year. I'm now going to hand it back to Bahija.

Bahija Jallal

Thank you, David. Thank you, Brian and Ralph. As you can see, the team is not letting up, and I'm grateful for everything they do. So looking ahead to the second half of 2023 and into next year, the commercial and medical teams will be focused on maintaining the momentum to reach patients who could benefit from KIMMTRAK globally. By the end of this year, we expect to launch in additional European countries and to achieve reimbursement agreements in France in 2024.
As you have heard, our commitment to people living with cancer is expanding as we embark on our first Phase III trial with our PRAME targeted therapy with the aim to randomize the first advanced cutaneous melanoma patient by Q1 2024. We will also continue enrolling more patients in the monotherapy and combination cohorts of the Phase I PRAME trial as we investigate the potential and further indications and will share updated data at congresses during the first half of 2024.
Finally, in Oncology, we plan to submit 3 INDs or CTAs over the next 18 months starting with the PIWIL-targeted candidates in Q4 this year. In Infectious Diseases, we intend to present data next year in our multiple ascending dose trial in HIV, and we continue enrolling patients with HBV as well as with hepatocellular carcinoma in the HPV trial. To conclude, Immunocore continues to execute on our strategy, and we remain really excited by the potential to reach even more patients with our ImmTAC's platform. We will now open the call for questions. .

Question and Answer Session

Operator

(Operator Instructions) Our first question comes from the line of Michael Yee with Jefferies.

Michael Jonathan Yee

Good morning and congrats on all the progress and congrats on the Phase III PRAME program, I guess I'll keep my one question to PRAME. David, can you just talk a little bit about your plan to start the Phase III in melanoma. I know you gave an update on the ESMO data and the duration. I think I just saw the curves. And how much of the ongoing expansion cohort data played a role on that?
Are you seeing similar response rates? I think you had 33%. Are you seeing same number of patients? Just talk a little bit about the totality of that, particularly in the expansion that you are seeing going on now? And then as a follow-up to that, you did comment that you're thinking about the next tumor type, can you just talk a little bit about what you're looking at and what you're seeing in front of you in ovarian and maybe lung cancer for PRAME?

Bahija Jallal

Thank you, Michael. David?

David Berman

Yes. Sure. So 2 questions. So number one, Michael, again, we looked at the ESMO data, which we showed a very promising update in terms of durability. We're enrolling the expansion, although it's still early, we looked at this data. And from a general drug development point of view, I won't speak specifically to the data, which we'll share next year. But from a general drug development point of view, Michael, we asked 2 questions. What are the percent of patients that are benefiting? And can the treatment effect in that population support the primary endpoint we're interested in, in this case, PFS.
For us, it was clearly yes, based on that data plus the original ESMO. We took that to the FDA who agreed with us when they reviewed the data. We shared that data with global KOLs and so I think it became clear to us and everyone who sought to move forward with the Phase III study. With regard to the other tumor types, we saw the activity in ovarian, which triggered us to do that expansion. That's still ongoing. We are very interested, of course, in lung and endometrial as well. So those expansions are still ongoing, and I think more to come on that as we review the data.

Operator

Our next question comes from the line of Tyler Van Buren with TD Cowen.

Tyler Martin Van Buren

Congrats on the strong KIMMTRAK quarter, and it's exciting to see all the new updates. Just a follow-up on PRAME and the cutaneous durability update. So clearly, the initial response rate is higher than KIMMTRAK, but again, just to follow up on durability. How confident are you that the durability you are seeing with PRAME even though it's early, is what you saw with KIMMTRAK. And I guess the same question just asked another way, based on the PRAME construct and design relative to KIMMTRAK when you consider TCR and CD3 potency, is there any reason why you wouldn't see similar durability?

David Berman

Tyler, so the only direct comparison we can do, and it's limited is in the uveal melanoma because that's where KIMMTRAK monotherapy has been mostly dosed and where we have PRAME data. And we have the 3 PRs with durations of 12-month, 16-plus and 17 months on PRAME. In the Phase III KIMMTRAK study, the median duration of response was 11 months. So that's Phase III, and this is Phase I. But I think the data for PRAME is very promising in terms of tolerability. In terms of differences between the molecules, I think that was your second question, the TCR end has the same picomolar potency, the CD3 end is the same. The peptide density for PRAME is higher than it is for gp100, but that's essentially what we know right now. .

Operator

Our next question comes from the line of Justin Zelin with BTIG.

Justin Reid Zelin

Maybe for David, can you just walk us through obviously, you're moving forward PRAME here in the first line versus KIMMTRAK and second and third in cutaneous melanoma. Can you just walk us through just the numbers for the accessible market for gp100 versus PRAME and cutaneous.

David Berman

Yes, Justin. So the current Phase II/III study, TEBE-AM and KIMMTRAK, we estimate to be 2,000 to 4,000 patients per year, and that's patients who have progressed on ipilimumab and BRAF targeted therapy and anti-PD1s. For PRAME in first line, part of the reason we're so excited about this, the opportunity is greater than 10,000 patients per year. That's the difference in terms of size.

Operator

Our next question comes from the line of Graig Suvannavejh with Mizuho.

Graig C. Suvannavejh

Congrats on the progress from me as well. A lot of questions on PRAME, but I would just want to focus on KIMMTRAK and the cutaneous melanoma opportunity. Well, actually, uveal, I know that there's been developments on the competitive landscape, and I know that there are thoughts around potentially combining KIMMTRAK with PRAME. So can you just give us your overall strategy there in uveal melanoma?

David Berman

Yes, I'm happy to take that and invite anyone else to join also. So KIMMTRAK had a great survival benefit, and there's a lot of patients who benefit. We are really excited about our combination of KIMMTRAK plus PRAME. We're currently doing the dose escalation optimization. They're both very active drugs and the idea there would be to study KIMMTRAK plus PRAME in the first-line setting. So once we have that data available and we can have a good regimen, we'll be able to share that data.

Operator

Our next question comes from the line of Justin Kim with Oppenheimer.

Justin Alexander Kim

Maybe just pivot a little bit to the HIV program. We're hearing a lot more interest in sort of the program as we see potential data near-term. Can you just frame for us how we should expect the initial data cut to look? And what exactly is the expectation for patients who withdraw ART over a 12-week time frame?

David Berman

Yes, I'm happy to take that. So in terms of the data, we were doing the multiple ascending dose where we treat patients for 12 weeks with intra-patient escalation and then at a target dose. We expect to have multiple cohorts completed, multiple dose escalations completed when we share the data. The data will include, of course, safety and biomarkers during the initial 12-week run in. After 12 weeks, we will interrupt both our bispecific as well as the antiretroviral therapy, and there we'll look for a rebound of the virus. Historically, I think the virus will rebound usually within a few weeks. I think most of the patients usually rebound within 4 weeks. We have a 12-week planned interruption. And so in terms of what we're looking for there it's a new field. I mean no one has ever really had a functional cure in HIV. So we're really excited to see where this data leads us. .

Operator

Our next question comes from the line of Michael Schmidt with Guggenheim.

Michael Werner Schmidt

I had a question going back to the planned Phase III study for PRAME and melanoma. So it sounds like the decision to go into first line was driven partially by the KIMMTRAK ctDNA data. And so I was just wondering about the concept, why the activity on ctDNA was higher in first-line patients and whether that is something that would be the case for other tumor types as well.

David Berman

Yes. I'm happy to start. So the data was based on the ctDNA, but also based on that survival in first line is better. I think we have 2 hypotheses, the first is that perhaps newly diagnosed first-line patients have a better immune fitness. And the second hypothesis is that the patient's tumors might not have been edited as much in contrast to after anti-PD1. So that's a pretty standard phenomena, by the way, for all immunotherapies. And so we do expect -- I mean, we haven't treated first-line patients, but we do expect that the activity will be larger in the first line for cutaneous as well.

Operator

Our next question comes from the line of Patrick Trucchio with H.C. Wainright.

Patrick Ralph Trucchio

Congrats on all the progress here. Just a follow-up question on the Phase II/III trial with KIMMTRAK in second line or later cutaneous melanoma. With the randomization of Phase III portion to commence immediately following completion of accrual into a Phase II portion, I'm wondering if you can discuss how efficacy from the Phase II portion might inform changes to the Phase III design. What changes could you implement? Would there be potentially accelerated pathway depending on what you see in that Phase II portion of the study?

David Berman

Yes, Patrick, that's a great question. And we specifically spent a lot of time designing that (inaudible) Phase II/III. So what we'll look at in the Phase II is, number one, we have a KIMMTRAK monotherapy. We have a KIMMTRAK-plus pembrolizumab. Do we need to have the pembrolizumab on board, yes or not. So we can decide to discontinue one of those arms. Number two, we'll be looking at the treatment effect relative to the control arm because we may need -- may be clear that we can decrease the size of the trial if the treatment effect is larger.

Operator

Our next question comes from the line of Ahu Demir Ladenburg Thalmann

Ahu Demir

Congratulations on the progress. Two on our side. First one is on the cutaneous melanoma. Could you elaborate more on the less frequent dosing, what led you to take that leap. And is it only driven by KIMMTRAK or is it driven by the Phase II data you got from the PRAME program?

David Berman

Yes, I'm happy to do that. So there's a couple of things that led us to the dosing. Number one was we talked about the KIMMTRAK experience. Number two is if you look at the -- if you look at the Kaplan-Meier curves for first-line PD1s, including nivolumab, you see that most of the progression, in fact, the majority, two thirds of progression occurred during the first 12 weeks.
So that's where we plan to have the weekly dosing because that's where the trial PFS is won and lost. After 12 weeks, the Kaplan-Meier curves really plateau out. And so we didn't think you need to have a weekly dosing regimen after 12 weeks. And then, of course, by one year, it moves to a once monthly regimen. And then I think just finally one other point. When we look at the PRAME data, but also KIMMTRAK we see the majority of the tumor shrinkage occurs in the first 12 weeks. So that's the time to have the weekly dosing.

Operator

Our next question comes from the line of Peter Lawson with Barclays.

Unidentified Analyst

This is Jay on for Peter. I just want to get a little more color around the organic growth for the second quarter for KIMMTRAK? And if you could give any talk to the volume of volume growth versus price growth? And any onetimers we should be thinking about here stocking orders and pricing benefits for U.S. versus ex-U.S.?

Ralph Torbay

So -- most of the growth was driven from the U.S. with the 14% quarter-over-quarter growth. That was pure demand growth. We did not see any difference in patterns of stocking per se. And you have to consider that we took a price increase at the beginning of the year in January of 2.5%.

Operator

Our next question comes from the line of Nick (inaudible) with Goldman Sachs. .

Unidentified Analyst

Nick on for Rajan. If we could just come back to the PRISM trial and the design there. I was just wondering what the rationale was for the selection of the 2 doses, they seem to -- or at least optically, they look quite far apart. Is -- why was there not a dose in between? Is that something that you've agreed with the FDA? And then looking further ahead, could you just give us an idea of what you see as the bar for efficacy and what good data would delight you?

David Berman

Yes. So with the selection of the 2 doses, we had multiple doses that were active and well tolerated in Phase I. In fact, we had a sevenfold dose range. We have 20 micrograms all the way up to 160 micrograms. And we chose the 160 originally based on modeling and simulation, although we had fewer patients at the lower doses. And I think that was the reason for the need to explore a lower dose. When it came to the selection of the lower dose, we had 2 choices, 20 or 40, 20 was the threshold dose. And we felt just in general good drug development never to choose the lowest dose because of variability in PK, you'll end up with some patients having too low of exposure.
And so that really set us on the choice of 40. With regard to the bar for efficacy, the nivolumab median PFS has really ranged, I think, between 4.7 months to, I think, 8 months. The most recent RELATIVITY-047 was 4.7 months from a median perspective, we're going to have a blended median PFS because we'll have some patients who are on Opdualag and some patients who are on nivo, but I think that the median PFS blended is probably still going to be less than 8 months. It just will depend on how many patients are randomized to the Opdualag.

Operator

Our next question comes from the line of Jeff Hung with Morgan Stanley.

Jeff Hung

How is enrollment going for the PRAME-A02 trial? And what should we expect to see in the first half '24 data?

Bahija Jallal

Mohammed, do you want to take that?

Mohammed Dar

As we had said earlier, we have moved from a Phase I footing to a Phase II footing. So we continue to open up in additional sites and continue to accrue to our multiple priority expansion cohorts as well as the standard of care combination. So all of that continues to go according to plan. And as we've said, we plan to share the data as it matures in the first half of next year.

Operator

Our next question comes from the line of Gil Blum with Needham & Co.

Gil Joseph Blum

So this is a bit of a hypothetical at this point, but it'd be interesting to see kind of what are you expecting to play would be between the PRAME agent and the KIMMTRAK agent in cutaneous melanoma. When you did previously PRAME post KIMMTRAK data and I suggested there was a ton of activity, but what happens the other way around?

David Berman

Yes. So in cutaneous. So the PRAME after KIMMTRAK was in uveal and although we didn't see RECIST partial response, it was really remarkable, the disease stabilization that we saw there, now why was it disease stabilization and not RECIST partial responses like we saw in first line, we don't know that we can speculate, but we don't know. I think we really are excited to study PRAME plus KIMMTRAK to understand how our platform works when you do multiple combinations.
It makes sense to study it initially in uveal melanoma because we have a lot of KIMMTRAK experience there. But I think clearly, cutaneous melanoma would be the next step. I think there are 2 ways to think about it, Gil. One is because both PRAME and gp100 are broadly expressed, we could target more cells within the tumor. And you could also think for cells that will express both, there might be more peptide HLA targets on the cell for the T cell to kill. So I think both of those are active hypotheses.

Operator

There are no further questions at this time. I would now like to turn the floor back over to Bahija Jallal for any closing comments.

Bahija Jallal

Yes. Thank you, operator. I just want to thank everyone for taking the time today and listening to the progress that we've made. So thank you very much.

Operator

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.