Phillip Koo: We're here today less than 24 hours after the FDA approval of Pluvicto, and we have Dr. Kendra Harris, Chair, Radiation Oncology at Tulane,. and Dr. Oliver Sartor. So, clearly, there's a palpable excitement with regards to this therapy that's now available across the US. What advice do you guys have for facilities who are looking to start offering this to their patients?

Kendra Harris: First they need to make sure that they have the right radioisotope conjugate on their RAM license. And now that we have achieved FDA approval, that RAM license needs to not include the word "investigational" because now it's standard of care. So that's really a first step. Then they can do an assessment of whether they have the appropriate equipment in either their radiation oncology or their nuclear medicine department, which involves having appropriate shielding equipment, having the appropriate sort of hot lab facility, and can make contact with the company in order to start a discussion about getting the contracts set up so that you can order this medicine. 

And then they need to find partnership with medical oncology colleagues because this is not a radioisotope which really should just be delivered without any attention to what's happening to the patient's other systemic therapy. And in that, Dr. Sartor and the other GU medical oncologists here at Tulane, Dr. Barata, Lewis, and Layton, have been really indispensable partners without whom our program of delivering molecularly targeted radioisotopes wouldn't exist.

Phillip Koo: That's great. I think it's very clear from the VISION trial that it is team-based science, as Oliver discussed before. And when it comes to the clinical implication or clinical rollout of this, it's going to be a team-based approach as well, and I don't see it being successful without that type of teamwork. So what are your thoughts on how to optimize this now that it is FDA approved?

Oliver Sartor: Well, the first thing is you've got to have a partner that understands what they're doing, and that's somebody like Kendra Harris who's been a delight to work with from day one. As a medical oncologist, I've been involved with patient care for over 30 years in advanced prostate cancer, and I'll simply say that the patients need to be continually managed. Some of them will end up with painful episodes. Some of them will develop anemia. Some of them will have complications associated with the disease. Maybe they'll have spinal cord compression. All those issues have to be managed. 

I'm sort of in the background, if you will, maintaining medical management of the patients. The actual lutetium is done by Dr. Harris and colleagues, and I don't think you can really do this without a teamwork. I honestly don't. I mean, I can't give the isotope. And on the other hand, I've been seeing these patients for years and years and I think I can manage their complications, hormonal agents and bisphosphate and other such things that need to be taken care of. And that's all in the context. I want to remind you that the VISION was best standard of care plus the PSMA lutetium. So the best standard of care is what we can do to help the patients every day of the week, and the lutetium is given every six weeks. Without her, we can't do it. Maybe I'm a little bit arrogant, but without me, we can't do it optimally. So it takes two, it takes teamwork.

Kendra Harris: Yeah. Being able to give the radioisotope is one thing, but one ought not be giving that radioisotope without the partnership of a strong GU-specific medical oncologist in lockstep. Because, as Dr. Sartor said, we have one piece, which is delivering this exciting therapeutic, but it's in addition to whatever the managing medical oncologist designate as the best standard of care.

Oliver Sartor: I might make a little bit of comment, and we mentioned medical oncology. There's some urologists who are expert in managing the disease-

Kendra Harris: Sure. Sure. 

Oliver Sartor: ... as well, advanced disease. 

Kendra Harris: Sure. 

Oliver Sartor: I mean, Fred [Saat 00:04:16], I mean, he's fantastic. Neal Shore, I mean, these are fantastic doctors. And so it doesn't necessarily have to be a medical oncologist, just be somebody who's accustomed and accomplished in managing the advanced prostate cancer patients. But then you have to have a partner.

Kendra Harris: Yeah. But this is the interesting point, which is it's a patient-led avalanche, right, which is that the magnitude of the benefit, the relative safety and really favorable overall toxicity profile when compared to the other options that patients have in this space, means that patients are flooding our phone lines and clinics trying to get this therapy. And so with respect to who gives the injection and who manages the management of the larger disease overall, there are lots of qualified people who, from a regulatory standpoint, can give the injection, and from, to Dr. Sartor's point, can do the management, that teamwork is required. The specifics are a lot of different configurations could work, and the more individual physicians and facilities that get approved, the better, because frankly, we can't handle even a fraction of the number of men who are qualified to receive this and want to receive it. So the more, the quicker, the better.

Phillip Koo:Great. The models, you're right, are going to vary across different practices. I think in the end, it's really the integration in that communication piece that'll set programs apart and be able to do this in a safe and effective manner. Final question I have is, how do practices go about identifying the appropriate patients? Because I imagine whenever we get this type of approval, you see a flood of patients, as you talked about, clamoring to get this. How do you manage that initially and how do you sort of foresee it playing out in six months or a year once that wave sort of flattens out?

Oliver Sartor: Well, most of the patients we've identified have come from our practice. We're using the novel hormones, the abiraterones, enzalutamides, apalutamides, darolutamides, in our everyday practice. And then, typically, there will be progression at some point, and then we use taxanes in our practice. And, certainly, we use use docetaxel, cabazitaxel. We use both. We've been involved with bazitaxel since 2010. And I'll simply say that it's an integrated approach and the patients sort of flow from the practice we already have in place.

Now, yes, we're going to get these outside calls. Those have to be evaluated. In truth, what I'd really like to do is to disseminate this new therapy across the United States, so you don't have to refer into particular centers. Yes, we're particular centers that ran the trial, but let's diffuse this out so that people can get it in their home towns. People don't have to travel. People can get it back where they're comfortable being treated near their homes. That'd be my hope.

Phillip Koo: Well, wonderful. Thank you very much for your time.