Mike King: Right. Okay. And I assume by your traditional practice, these new responses are all confirmed responses, yes.
Dr. Steven O’Day: So, out of the eight patients, we have four responses, three are confirmed, and a fourth is waiting for confirmation with the next scale.
Dr. Garo Armen: So just to clarify, by the way, the way it works with our reports, the definition of a confirmed response is the outcome of the second scan, not — whether or not first is a real response or not real response. And we’ve confirmed that the first response is a bonafide response. But by definition, you have to wait for the next scan to just give a check mark of it’s confirmed. So, none of the four patients have not confirmed with a second scan.
Operator: David Dai with SMBC. Your line is open.
David Dai: So first question is just around the first active trial MSS CRC. Since you will be looking at to submit BLA in 2024, if you assume that we’ll see some top line data in 2024. And then I guess sort of similar to the question that we had earlier, do you — just to confirm that you could be rolling down liver mets patients in that trial. Is that correct?
Dr. Steven O’Day: That trial — the Phase 2 trial is in patients who have no active liver mets, meaning they could have never had liver mets or they would have had treated liver mets, but not active at the time of the trial opens.
David Dai: Got it. And so just to confirm, are you going to be — we’re going be seeing the top line data in 2024 — early 2024. Was that correct?
Dr. Steven O’Day: That is our expectation, but we’ll have to follow the data and the accrual.
David Dai: Got it. That’s helpful, Steve. So another question just around the expectations for the upcoming Society of Gynecology Oncology annual meeting. So how many should we be expecting? And what’s the length that follow-up for these patients with the ovarian cancer patients?
Dr. Steven O’Day: So we’re not going to give you the details, but stay tuned for the oral plenary presentation on the 27. What I will say, though, is we’ve obviously had multiple conferences in front of GI community with our MS stable colorectal. The real only opportunity for expanded other diseases was at SITC last year where we highlighted lung and ovarian and sarcoma. We did have the opportunity to present the sarcoma data, as I said, at a disease-specific sarcoma meeting last year with CTOS. And this is our first opportunity to really present this data, the GYN data, the ovarian data in front of a large GYN community. So, we’re looking forward to that and there will be additional data and follow-up presented. And remember, we’re producing follow-up that’s mature, too. So the number of patients presented is less than what we are currently enrolled. So, we feel that this is very important data that will be presented in a couple of weeks.
David Dai: Got it. And then just one last question around the safety side of botensilimab, balstilimab combo. So we do see some incidence of unit-related Grade 3 plus diarrhea and colitis in CRC. So what are the latest thinking around mitigation strategies around that. And then how has been the receptivity of the physicians with respect to balancing the efficacy and safety side of equation?
Dr. Steven O’Day: So that’s a great question. Toxicity-related — immune-related toxicity correlates with clinical benefit. The important thing is early intervention, and it’s highly reversible with effective treatments. We’ve come a long way in the management of RAEs. In terms of the diarrhea colitis, it’s a spectrum. It’s now — diarrhea and colitis are the same immune-related phenomenon in the gut. And we have reported this toxicity and anywhere from 30% to 50% of patients at different doses and schedule. It’s dose schedule dependent. The important thing is that it’s are manageable with early intervention with steroids and TMS inhibitors, and we have a very targeted program in our Phase 2 trials, the early recognition of this toxicity and early intervention and subsequent prophylaxis with the combination of steroids and TNF inhibitors.
