Philippe Bishop: So this will be obviously — it would the eligibility criteria. So for patients that would be considered to continue on pembro — to receive the pembro containing regimen, those indications are, as you know, based on the pembro label. So there, we have some differences with the monotherapy. And the monotherapy, as you know, was based on our earlier data showing that there was a high prevalence of target in these various tumor types. So if a physician thinks that pembro is not indicated or the patient had already received PD-1 or PD-L1 agent and unlikely to respond, it is likely that they’ll be brought on to the monotherapy if they need eligibility. And for those for whom the physician believes that continuing on pembro would be suitable, we would probably see those coming on through the combination arm.
And I should point out that urothelial malignancies, esophageal malignancies, that head and neck malignancies and subset of breast cancer, the triple-negative breast cancers and the hepatocellular carcinoma would be indications that we would see in the combination arm that will not be appropriate for the monotherapy arm based on the eligibility criteria.
John Orwin: Yes. And I think even in the setting where we have cohorts open for monotherapy and carbo with pembrolizumab, I think we would likely need to show more suggestion of single-agent activity for the FDA anyway. So to some extent, we’d like to see more combination patients. But to some extent, we also benefit from more monotherapy because I think that’s something that, that individual contribution is something that probably the FDA would want us to be after. But at this point, those centers, most of them would have been basically the choice and use their own discretion, at least, ovarian, colorectal.
Operator: Our next question comes from the line of John Newman of Canaccord.
John Newman: Just wondering with the currently ongoing Phase 1 study for 101, how much follow-up time will be allotted. Just wondering if you’ll be able to follow the study longer term for things like overall survival, where perhaps there’s a signal that shows up that doesn’t initially show up in the response rate.
Philippe Bishop: Yes. So right now, the data that is being collected, obviously, is response rates, and we’re looking at progression-free intervals. Survival is collected when that event occurs for patients that are on study during the period of follow-up, but we are not following patients once they come off study. So the overall survival data would not be something that we would expect to report on with this trial. I think what we’re looking at is for response rate and disease control to give us an idea of the signal and help us prioritize which indication is most likely to be seeing, driving some kind of benefit from being treated with ATRC-101, and that sets the stage related for the Phase 2 study that John was talking about, where there in a more formal way and ideally in the controlled fashion, appropriate control, we would be assessing what a true treatment effect would be for Phase 3 in order to appropriately design the Phase 3 trial.
And that Phase 2 could include collecting survival data.
Operator: Our next question comes from the line of Tony Butler of EF Hutton.
Tony Butler : So if I understand correctly, preclinical work had demonstrated that ATRC-101 actually remodeled the tumor microenvironment, if I’m correct in that. If that’s true, one of the questions that comes to mind is this notion of combination where is — I think you stated utilizing pembro with 101 was really related to those indications where pembro was already indicated. If that’s true, that’s fine, and I’m respectful of that. But the real question is in cold tumors, for example, in CRC and ovarian where pembro just has no effect, there may be — if, in fact, you do get TME remodeling, there may be some really signals here where in those tumors, that combination could then, therefore, be And so for example, it wouldn’t take a lot from a response rate to really demonstrate in the late line CRC patient that you really have something of benefit.
