Eric Joseph : It was sort of — it’s actually more about as you are backfilling some of the prior dose cohorts to sort of take into consideration when thinking about or deflecting the Phase 2 recommended dose. I guess, really, it’s a matter of what dose cohorts, what dose levels are you perhaps growing more aggressively prioritizing and whether sort of the patient mix going in is either perhaps being more concentrated to certain histologies or perhaps even being opened up as well.
Mark Goldsmith : So it’s about monotherapy and dose selection comment.
Steve Kelsey : For pragmatic reasons, Eric, which are related to, firstly, the number of patients queuing up to get on the study. And secondly, the relative positive guidance coming from the FDA about the specific requirements for — to fulfill the Project Optimus initiative. We are aggressively backfilling most of the dose levels actually at 300 and below. And the priority right now is to backfill with patients who have non-small cell lung cancer and pancreatic cancer because those are the ones that the FDA are going to be interested in, in the exposure response analysis that we submit them for when we recommend a go-forward dose into Phase 3. There is an amendment to this protocol, which has now been approved, it’s on clinicaltrials.gov, which allows us to expand in several different histologies, including colorectal cancer and other tumor types.
And it also includes — does include G12C mutant tumors. But that’s completely separate from the exercise to select the recommended Phase 2 dose for both non-small cell lung cancer and pancreatic cancer, the parallel activities at the moment.
Eric Joseph : Okay great. Very helpful. Appreciate you taking the questions.
Operator: One moment for our next question. Our next question will be coming from Jonathan Chang of Leerink Partners. Your line is open.
Jonathan Chang: Hi, guys. Thanks for taking my questions. First question, how should investors be thinking about time lines for next data updates across your pipeline?
Jack Anders : Yeah. I don’t have much specificity on that right now. Obviously, we’ve been asked that a lot over the last couple of weeks. We just need to see how things play out. I think it’s pretty clear what we’re trying to do in the near term. It’s largely around dose selection and acquiring more durability data and, to some degree, more ORR data at higher doses. So I don’t think we’re talking years out, but I can’t give you specificity the most sort of narrow question we get asked is, will we make a presentation at ASCO, and I just don’t know. In order for us to do that, we’d have to submit an abstract in February, which means we have to know what it is we’re going to present in May to do so. So we’ll just have to see. But we’ll try to provide more clarity once we sort of get past these next couple of months and give some more specificity about expected milestones in the coming year.
Jonathan Chang: Understood. And second question, what do you see as the duration of disease control and PFS benchmarks in previously treated PDAC and what do you see a sufficiently good duration of disease control and PFS data relative to those benchmarks?
Jack Anders : Yeah, I think Steve can comment mostly on the first part of that question because that’s objective information. And then as to what we consider an improvement is, will be the subject of ongoing conversation with experts in the FDA.
Steve Kelsey : Yeah. The benchmark right now is pretty universally set at around three months. There are a few series where the PFS is two months and one or two where it’s longer than that. But the vast majority of studies that have been done in that second-line salvage setting show three-month PFS. And frankly, that’s when the scans are done, and there’s a very dramatic drop-off in freedom from progression at the point at which that second scan is done. So I think that’s the key — that’s definitely the benchmark to be. Your question about how good is good. I mean there are three constituencies that we have to satisfy here. That’s the regulators, those the prescribers, and then there’s the payers, and those exist in multiple geographic jurisdictions.
