Garo Armen: For the pancreatic?
Colleen Kusy: Yes.
Garo Armen: Okay. So just to recap, the data package that we will go through the FDA with for the CRC indication is approximately 150 patients in our Phase 1 trial and the 230 patients in our Phase 2 trial. Now with pancreatic, the next step for us, and I will ask Dr. Steven O’Day to elucidate more. But the next step for us is to look at the randomized data result from the expansion cohort of the existing trial. As you know, we observed some remarkable activity in second-line pancreatic cancer patients that were treated with full fury and then relapsed. And the standard of care for them is abraxame. Now the standard of care, unfortunately, is not curative. And these patients relapse within a short period of time. Furthermore, the response rates for these patients according to the experts and published information is in the range of 10% to 15%.
So we’re talking about reference arm being 10% to 15% with response rates being very short in duration. Now, of course, the denominator of the data that we presented is small, but the fact that all patients have seen a significant drop in their cancer counts. And all patients have seen a shrinkage in tumor, now remind you, not all of them are classified responses, but patients have seen a shrinkage in their tumor size, has given us a high level of confidence that the trial should be expanded, and this is what we’re doing. So we have enrolled, I believe, around 30 patients in a randomized trial now. That data is maturing. And as the data matures and we confirm the results from the smaller denominator of the initial patients, then I think we will have a reason to go to the FDA and ask them for the requirements for a potential accelerated approval for this indication.
Now we have also, as our colleagues may have said before, other indications that are potentially indications that we will go for approval. One is, again, all of these will be subject to expansion of our trials to confirm the initial results on a smaller denominator. But the smaller denominator results are so compelling that for example, in lung cancer, in EGFR mutant patients, we will investigate. In fact, there’s a subset of specific EGFR mutation that we will expand that cohort to understand and verify the profound reduction in tumor size that we have seen in our earlier trials. So that will be similar to what J&J did for a larger patient population with their bispecific. And last report that I saw is for a patient population that is about a tenth of the size of what we may be pursuing, the estimates for their product is in the billions in sales.
So there are opportunities that we will pursue that are driven by small trials, very specific patient populations that will yield very high response rates and typically, de facto biomarker-driven identification of these patient populations and that applies to lung cancer, certain subsets of lung cancer and that applies also in a different format for the neoadjuvant. And in this particular case, what we have seen in our neoadjuvant trial is a surgery sparing and when we talk about surgery sparing, we’re talking about surgeries that would be debilitating for the patient. Removal of the rectum is a debilitating outcome, particularly in the younger patient population. Particularly. I mean, it’s debilitating for all patients. But if you’re in your 20s and 30s, and you have a lower colon — lower left colon tumor that is cautious to direct them and that’s going to yield radical surgery that would be horrible.
So if we can prevent that with our neoadjuvant strategy, we believe that’s a tremendous opportunity. So we’re looking at all of these options and more, of course, and stay tuned.
Colleen Kusy: That’s very helpful. One really quick follow-up, if I can. Just on the neoadjuvant, the next neoadjuvant setting study, will that allow for the potential to get surgery altogether? Or will all of those patients proceed to surgery?
Garo Armen: Well. Okay. So I’ll let O’Day elaborate, but I know at least one patient after a complete response, refuse to have surgery. Now of course, that’s a tricky situation. We got the ethical considerations, in which we don’t have an approved product in that indication yet. And hence, that recommendation cannot be made by a physician for ethical reasons right now. But if a patient refuses to have surgery, it’s their prerogative, it’s their life. But you are seeing that kind of a potential develop. And of course, I want to stress the fact that everything has to be done properly with appropriate regulatory guidance. And everything has to be done in an ethical way so that we don’t jeopardize the well-being of patients.
Operator: We’ll go next to Matthew Phipps at William Blair.
Matthew Phipps: So just curious, when you said data in the second half from the Phase 2 colorectal study, do you think you’ll have PFS data by that point? It seems like given the poor prognosis in this patient, that could be possible.
Garo Armen: So I will refer to our regulatory experts, but PFS in these patients relative to OS is such a short interval difference that I think OS is the gold standard, PFS is much less so. Steven, Todd, do you have any comments on that?
Todd Yancey: Yes. Steve, go ahead, and I’ll talk.
Steven O’Day: Matt, yes, I mean, obviously, we’ll have response rate, duration of response, PFS and preliminary survival in these patients as they mature over the course of the year from their last — from when they were accrued. So obviously, it’s a composite endpoint. But to Garo’s point, clearly, response and duration of response is what drives and prolonged stable disease drive the survival curve. So our primary endpoints are obviously response, duration response and then ultimately, the gold standard survival.
