Immunocore Holdings plc (NASDAQ:IMCR) Q2 2023 Earnings Call Transcript

Michael Schmidt: Hi guys. Good morning and thanks for taking my question. I had a question going back to the planned Phase 3 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.

Brian Di Donato: Yes. David or Mohammed, you can?

David Berman: Yes. I’m happy to start. So the data was based on the ctDNA, but also based on the survival and first line is better. I think we have two 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-PD-1. 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: Thank you. Our next question comes from the line of Patrick Trucchio with H.C. Wainwright. Please proceed with your question.

Patrick Trucchio: Thanks and good morning, good afternoon, and congrats on all the progress here. Just a follow-up question on the Phase 2/3 trial with KIMMTRAK in second-line or later cutaneous melanoma. With the randomization of Phase 3 portion to commence immediately following completion of accrual into a Phase 2 portion, I’m wondering if you can discuss how efficacy from the Phase 2 portion might inform changes to the Phase 3 design. What changes could you implement? Would there be potentially accelerated pathway depending on what you see in that Phase 2 portion of the study?

David Berman: Yes, Patrick, that’s a great question. And we specifically spent a lot of time designing this seamless Phase 2/3. So what we’ll look at in the Phase 2 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: Thank you. Our next question comes from the line of Ahu Demir with Ladenburg Thalmann. Please proceed with your question.

Ahu Demir: Good morning. Congratulations on the progress and thanks for taking my questions. 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 2 data you got from the PRAME program?

Bahija Jallal: Go ahead, David?

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 PD-1s, including nivolumab, you see that most of the progression – in fact, the majority, 2/3 of progressions occur during the first 12 weeks. So that’s where we plan to have the weekly dosing because that’s where the trial PFS is one and last. 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: Thank you. Our next question comes from the line of Peter Lawson with Barclays. Please proceed with your question.