The answer is often not, no. Now of course, we don’t know if we’re curing cancer. We don’t know that. And the term curing cancer is a very dicey term because how do you demonstrate it? How do you clinically demonstrate curing cancer? And the only thing that we know for sure is that there is a product called Yervoy that has cured, de facto cured a slice of melanoma patients. But it’s been mostly restricted to melanoma. In fact, Dr. O’Day was one of the pioneers in clinical development of Yervoy. Now of course, one of the attributes of the Yervoy is that it binds to CTLA-4, a very important receptor in the activation of the immune system, specifically T cells. Now we also know that our botensilimab binds to CTLA-4, but it does so many other things.
So we are hopeful, hopeful that eventually, botensilimab’s activity will be broader than what Yervoy’s activity has been in melanoma. And so with that, of course, we’re excited about what we’re going to be doing with it. And that makes the question of a like-minded partner that will put in the resources to develop botensilimab and balstilimab for the kinds of cancer patients that deserve it, deserve it, meaning that our aim is that once we get the regulatory buy-in and we go for our first BLA filing, our aim is an explosive expansion for the development of botensilimab. Explosive expansion because, as you know, we have said, across nine different indications, with varying denominators of 900 patients in total, we’ve seen some remarkable activity.
There is no two ways about it, remarkable activity. And that is, of course, the basis for why the right partner that will be selected hopefully, in the next several months would be the partner, not just for us, but for the benefit of the patients to develop this product in the way it deserves to be developed. So again, we have, I think, Christine slipped a number of active discussions. There are a number of active discussions right now that are going on. And unfortunately, on one hand, these discussions take a long time. Our longest corporate discussion that has resulted in a significant partnership has taken nearly two years. The shortage one was a year. So I’m not suggesting that the partnership is going to be a year from now. But I just want to give you guidance that these things take time.
Mayank Mamtani: Very helpful, Garo. And just maybe lastly on that marketable activity just on the pancreatic and this TKI refractory lung cohort data, which seems new, could you talk to what patient numbers you’re expecting to have in your mid or second half update for pancreatic and maybe lung, if you could just comment on that. Thanks again for taking our questions.
Garo Armen: If I may ask either Steven or Todd to address this question, and if you have more specific clarification for the questions, please feel free to ask.
Steven O’Day: So yes, Mayank. In terms of pancreas, we have a randomized Phase 3 trial, and we expect to treat 60 patients total, 30 on each arm, and that trial is actively accruing for further proof-of-concept. In terms of the lung data, we have expanded the cohort, as we’ve said, to approximately 50 patients. This data is maturing. We’re showing you the preliminary TKI data in our press release today. You can see in that very refractory TKI population of seven patients, we had two patients have responses and both of them were complete. The overall data continues to mature, and we’ll have more data in the second half of the year to report.
Operator: Next, we’ll go to Colleen Kusy at Baird.
Colleen Kusy: Can you just comment what are some of the outstanding items do you think you need FDA feedback prior to the MSS CRC filing?
Garo Armen: Is the question, what are the alignments with the FDA that will comp to potential BLA filing?
Colleen Kusy: Yes.
Garo Armen: Okay. So we want to — first of all, we’ve made a strategic decision because we were moving, as I said earlier, we were enrolling our clinical trials rapidly, for example, Phase 2 trial and go very rapidly and it was a very important trial for us to go to the agency with because of the dose selection as well as the contribution of the elements. And of course, we had also a small reference arm. Now of course, mind you, this trial is not powered statistically to show any differentiation between the arms. However, it is designed to address the project optimist questions. And so the question was for us, if we go to the agency and ask them a question in an abstract form. What is this? What is that? The answer is likely to be, well, when you have the data, come back to us, present it to us, and we’ll give you an intelligent answer.
And so in order to for us to be able to get to that point, we made a strategic decision, Colleen, that we would wait until all the data mature to the point where we had a compelling package with to present to the FDA. So that’s the reason why we are waiting until the data matures, which will begin somewhat before the middle of this year. And as you know, procedurally requesting meetings and being granted meetings or in a discussion with a comprehensive data package takes a little time. So we are planning on asking for the meeting very soon and planning on having the meeting sometime around mid-year, plus or minus a month.
Colleen Kusy: Great. And then just one follow-up on the pancreatic development program. I know we’ll have data from the Phase 2 trial midyear. What would the next steps look like in the development path towards approval there?
