Alicia Morgans: Hi, I'm so excited to be at AUA 2022, where I have the opportunity to speak with Dr. Oliver Sartor. Thanks so much for being here.

Oliver Sartor: Thank you, Alicia.

Alicia Morgans: I wanted to speak with you today about the NCCN guideline updates on how we can think about selecting patients using a PSMA PET scan for treatment with Lutetium. I'd love to hear your thoughts and comments on that as this was a new update.

Oliver Sartor: Absolutely. Brand new update. And it's interesting because I think it's very valid. And if you go to the VISION Trial and that's the basis for the PSMA-617 Lutetium-177 approval, that you go to the trial and you see it was all PSMA-11 gallium-68 that was used in patient selection. And so why would you consider a different type of PET scan, if you have one PET scan used in the trial? And the answer is, because they're essentially equivalent. The actual data in advanced patients, has not been well compared. So we have the DCFPYLF-18 scan, otherwise known as Pylarify. And if you look at the initial FDA, it mentioned PSMA-11 gallium-68.

Alicia Morgans: The FDA for Lutetium.

Oliver Sartor: The FDA for Lutetium, thank you for the clarification. But PSMA PET's used in the selection. But in this case, I don't think there's a substantial difference between the PSMA-11 gallium-68 and the DCFPYL F18, to say that we have to have one scan or another. I think either is acceptable, I'm on board of the change from the NCCN. And I think what'll really be important is how the insurance companies really respond. Oftentimes they do respond, but interestingly, I've heard through the grapevine that the DCFPYL F18, even before the NCCN change, has been accepted for the PSMA Lutetium treatment paradigm. So I'll simply say, I think this is going to be moving forward. It's good for patients because now there's more availability when we talk about multiple types of scans and I'm all for flexibility. And in this case, I think the flexibility is perfect. So let's go forward.

Alicia Morgans: Wonderful. So really I think this has been a bit stressful as clinicians have been thinking about using Lutetium, they didn't necessarily think that the PSMA PET identification of patients required for treatment was going to be tied to a certain tracer. And as you said, the label for Lutetium was really tied to this gallium PSMA PET, so there was a lot of consternation. Is this going to allow me to use DCFPYL or not? Because the label suggests gallium, but the NCCN guidelines now expand that, or at least suggest that we could use either a gallium PSMA PET imaging agent, or a DCF PYL imaging agent, at least through the NCCN guidance.

Oliver Sartor: You know, I'm comfortable with either one. And I'll simply say that the critical element is to be able to choose the patients in a reasonable manner. If you go back to the VISION trial, we excluded about 13% of the patients on the basis of a PMA PET scan. By the way, it's not always PSMA PET negative. Sometimes it's lesions like in the liver that maybe two centimeters has seen on a CAT scan, but they're PSMA cold, even though they have other diseases positive. Those patients were excluded. So about 87% of the patients who get a PSMA PET are going to be appropriate for the PSMA Lutetium, but not everybody. So I think you do need a scan beforehand, and we're going to be hearing more, by the way, about the scans and the prediction of responses fairly soon. Come back for ASCO 2022.

Alicia Morgans: Wonderful. So always stuff for us to look forward to. I really appreciate you talking us through the NCCN guideline updates and how we can think about selecting patients for this new therapy Lutetium PSMA. So thank you so much for your time.

Oliver Sartor: Thanks, Alicia.