Phillip Koo: 

Moving back onto EMBARK, you mentioned how it was first presented 18 months ago or so. Now we have continued data coming from it. Any changes or what should patients expect now that they see this type of data presented at a big meeting?

Zachary Klaassen: 

Yeah, I think, you know, with these, what these sort of supplementary or secondary analyses do is just give us as providers a little more confidence that we're not seeing something different in patients that are in the real world.

And so what I mean by that is, again, like, until they did this analysis, did we really know if a patient that started with radiotherapy or started with a prostatectomy, did their primary therapy mean they were going to act differently once we gave them the EMBARK protocol, you know enzalutamide plus Lupron or enzalutamide alone?

And so, the answer is no, it's more of, the answer's no because it doesn't matter which one you get. So, it's a more of a confidence for us to be able to tell patients, you know, we know this data's been presented, it's great data, but now we have all these other little check boxes that help us with our confidence in saying, yeah, we think this is the right treatment for you.

Phillip Koo: 

You know, that's great. So, for EMBARK and this data, it really sort of solidifies its presence and its use as a great tool. Alright, so for ARANOTE, interesting, that was presented before…. You kind of talked about it. There was interesting news at ASCO, I think at the tail end of ASCO with regarding to ARANOTE. So, can you sort of walk us through that process?

Zachary Klaassen: 

Yeah, so as I mentioned, the FDA approval just kind of happened to be around the time of ASCO. So, there was a lot of excitement around that. There was some buzz that they were going to get it maybe in May. But again, we had an idea that darolutamide works great with metastatic hormone-sensitive prostate cancer in combination with docetaxel and ADT. And so, when that came down at a huge cancer meeting, obviously among providers, that's a huge deal. So, it was really exciting to know that we could go back to our clinic the next day literally and start giving the combination of just the darolutamide plus ADT.

And I think it's important when we're thinking, we know that the triplet works great for a lot of patients. Perhaps people aren't chemotherapy candidates, whether it's they have kidney dysfunction, they have already neuropathy, they can't feel in their fingers or their feet or they have bad hearing, things that we may not want to give a chemotherapy to. We know that in those patients, now we can just give the doublet therapy of darolutamide and ADT. So, I think when we look at somebody who's a candidate for treatment intensification, it's still important to give chemo that to the patients that truly need it. And that's a discussion between the physician and their patient and their family members. But now we know that doublet therapy works excellent as well.

Phillip Koo: 

That's great. So, ARANOTE, the data comes and then all of a sudden it gets a change, and FDA approved and their label can be updated. AMPLITUDE sort of falls into a different space where we're seeing the data from AMPLITUDE. When can patients expect to see this available for them if they're in that metastatic hormone sensitive space?

Zachary Klaassen: 

Yeah, I think, you know, it's taking the information we already know about niraparib and abiraterone in mCRPC. So, we know it works in mCRPC. We know that combination is safe. They'll need a new label for the metastatic hormone-sensitive disease space, which is what AMPLITUDE was.

So, I'm hopeful again, because we already have a label in prostate cancer, advanced, that they'll be able to move it quickly into the metastatic hormone-sensitive space. And so, I think, again, I'm hopeful that's in that 6-to-12-month timeline, that we'll see that.