Andrew Berens: I know you’re not able to promote first-line for PADCEV until you get a label, but I’m just wondering if you’re already seeing some usage following the presentation of the data set. Some of our doc checks suggest that they’re already using it in the first line already. And then, I just was wondering if you could — you mentioned developing some novel ADC technologies. Wondering if you could let us peak under the covers and see if you can give us an idea of what you’re looking at?
David Epstein: So, first, I’ll just ask Chip any sense of whether or not PADCEV may be already used in the first-line bladder cancer setting?
Chip Romp: Yes. So that would be organic. We don’t promote to that, obviously. But there’s been a little bit, but not much. It’s minimal right now.
David Epstein: And then you asked for — to hear a little bit more about our discovery efforts. At JPMorgan, we talked about multiple waves of therapies and technologies. And we were, I would say, purposely superficial so as to not give too much away. I indicated in one of my answers already earlier today that we are filing our first campto-based payload INDs. So, that’s certainly one area will be coming in the very near term. We have a number of other proprietary targets that we think will be particularly suitable for our current vedotin technology. And then, I’ll go a little further and just say we are now working on what we believe could be better linkers as well as payloads that are quite different from anything you’ve seen so far.
There’s quite an expertise into our discovery group. Roger, as you know, recently became Head of R&D and we’re working to prioritize where we focus. There’s actually many, many opportunities, and we’re going through the process of now choosing the assets, which we will heavy up on the resources to get them into the clinic.
Andrew Berens: Great. I appreciate it. And congrats again.
Todd Simpson: Thanks, Andy. I think we have time for one– maybe one more question. Operator?
Operator: Our next question comes from Dane Leone from Raymond James.
Dane Leone: One for me, if you will. With regards to the readout that we could expect of HER2CLIMB-02, it’s interesting, it’s obviously a larger study, well-controlled, signal of the benefit of tucatinib with trastuzumab amazing. And the question that I think a lot of people have is what are the actual expectations statistically that your team put in place to tease out a PFS signal in this study. And is your expectation that that PFS benefit would come primarily from tucatinib’s ability to address brain mets and progression on intracranial disease, or is your team ultimately looking for a bigger PFS hurdle more broadly from the synergy of the two agents?
David Epstein: Hey Roger, do you want to start on that one?
Roger Dansey: Yes. It’s an interesting question. Just to remind you or sort of set the scene for you on HER2CLIMB-02, it has the same essential design elements as HER2CLIMB. And importantly, for this population, obviously, Kadcyla is a well-known drug, it is used in second-line and plus, and as David said, focusing on metastatic disease. But as we did with HER2CLIMB, the eligibility criteria allow patients with brain mets, either controlled or active. And so, we expect to have a meaningful number of patients with brain metastases in HER2CLIMB, obviously, as we did in — in HER2CLIMB-02 as we did in HER2CLIMB. With regard to assumptions around treatment effect, just to remind you again of the design, this is a simple add-on design.
So, this is the addition of tucatinib to Kadcyla. And so, any benefits of tucatinib accrues, I think, will be pretty evident. I can’t share with you specific assumptions. But we are looking for all of the above. You mentioned, are we looking for treatment effects in a broad population? Yes. Are we looking for meaningful treatment effects in a subset of patients with brain metastases? The answer is yes. And I think we see the potential for tucatinib instead of being an all decision for physicians, if a trial is positive and the results are meaningful, physicians will and patients be able to make the decision if Kadcyla is part of the treatment plan to add tucatinib to that combination.
David Epstein: Great. So thanks, Roger. Let me just conclude by saying this is going to be a very exciting year for us, many data and regulatory milestones. I’m thrilled to be here, and I thank you for all the attention you’re paying to our company. With that, we’ll close the call.
Operator: Ladies and gentlemen, with that, we’ll conclude today’s conference call and presentation. We do thank you for joining. You may now disconnect your lines.
