Alicia Morgans: Hi. I'm so excited to be at AUA 2022 with Dr. Oliver Sartor. Thank you so much for being here.

Oliver Sartor: Thank you, Alicia.

Alicia Morgans: Wonderful. So, I wanted to talk with you a little bit about the implementation strategies that you have used, that we all might emulate, for getting Lutetium into our clinical practices, especially in light of some recent supply chain issues that have come up. Can you tell us a little bit about what's going on, and how we can think through getting Lutetium to our patients?

Oliver Sartor: Well, first of all, let me talk about getting Lutetium to the patients. And then, we'll talk about the supply chain; it's two—


Alicia Morgans: Okay.

Oliver Sartor: —distinct issues. The first thing is, I'm a medical oncologist, you're a medical oncologist, neither one of us is licensed in an appropriate manner to be able to administer an isotope like Lutetium-177. We have patients, we can control the patient population, and who we see, and be able to make the proper referrals. But I think, the most important thing for somebody like you and me, is to have a good partner. And I'm very fortunate. I've got a great partner. And we work very closely together. She's a radiation oncologist, and we're very simpatico, and our clinics are literally adjacent to one another. And we've created a multidisciplinary team that really works.

And I don't think there's anything better that you can do. Because first of all, somebody's going to have to have the license, and somebody will likely have the patient. They may not be the same person. So that means working together. And yes, there are licensure requirements. You have to have your state licensure for the particular isotope in the proper quantity. You're going to have to be able to have a safe harbor when the drug arrives at your facility. You're going to have to be able to measure, and be able to administer the drug in a safe environment, and be able to give proper instructions to patients, so when they exit, that they'll follow safe practices. But I think, the real key thing is multidisciplinary care, and really, communication and cooperation. That's the key to our success at Tulane.


Alicia Morgans: Absolutely. And you've worked hard to establish that multidisciplinary collaborative relationship. For people who don't necessarily have that established, what would your guidance be?

Oliver Sartor: Well, I think this therapy lends itself to multidisciplinary care. And I believe, that if you don't have those relationships set up, well, let's get them set up. You know? Now's the time.

Alicia Morgans: Yeah.

Oliver Sartor: Why wait? If I look further down the line, right now we have the initial FDA approval, I'm anticipating more FDA approvals. I'm seeing a slice of the patient population that's this big today, but it's going to be that big tomorrow. So why wait until tomorrow to set up something that you're going to need? Not only today, but it's going to be in even more demand as you move into the future. So working collaboratively, I think, is going to be real key. Having somebody who really understands the patient population of prostate cancer is key. Somebody's going to have to do the patient selection. Right now, we're talking about PSMA, PET positive, by certain criteria set out in the VISION trial adopted by the FDA.

You're going to have the patient who's going to be post-taxane, post-novel hormones, such as abiraterone/enzalutamide. And you're going to have to have a patient who has metastatic disease, castrate-resistant disease. So, fulfilling the criteria, and then working the referrals, and doing the coordination. And by the way, implementing the scans. Because you need a PSMA PET scan, in order to properly select the patient. All of that goes together. Nuclear medicine, radiation oncology, or nuclear medicine for administration, proper facilities, and a population of patients that are trusting and willing to accept the referrals that you generate. So that all fits together.

Alicia Morgans: It absolutely does. And while patients are getting treatment, also having someone be the point person for supportive care needs, or also, of course, to follow up if cytopenias are developing, and those kinds of things, is really, really important too.

Oliver Sartor: Really important. These are advanced prostate cancer patients. If you actually look at the median survival in VISION trials, a little over 15 months, now these patients have bone metastases, in the vast majority of cases, they may have visceral metastases. They may have cytopenias. They may have complications with therapy, such as dry mouth. They are going to need to be managed, not just injected. The idea that you'll inject somebody every six months, or every six weeks, and that's going to be the proper way to do it, that's not so. These are patients who need care, and all the supportive care measurements. The bone health agents that are potentially important. The management of palliative care, in terms of the morphine. By the way, external beam radiation. Important concomitant therapy that can be used in combination with Lutetium. All of that has to be managed and dealt with. It's not just about giving an injection.

Alicia Morgans: Absolutely. Well, one other thing that I think we should acknowledge, is that there have been some recent supply chain issues. We are expecting that they will go away at some point in the near future. But right now, we are looking at a paucity of availability. Would love to hear your thoughts on how we think through this, and manage our patients as we wait for the drug.

Oliver Sartor: No. Great point, Alicia. We're sitting in an incredibly awkward time. So now we have an FDA approval, and that was on March 23rd. And here we are speaking at AUA 2022, and we're sitting about the second week of May. And it turns out that, the availability of the PSMA Lutetium is simply not there. And through strange coincidences, bad luck, if you will, the two manufacturing facilities for Novartis, and it's very specifically Novartis's drug that's gotten FDA approved, both of them have gone down because of quality issues that arose in the manufacturing process. Now, we've been given the word that, six weeks is the approximate date. It's hard to be precise when you're talking about quality issues that need to be resolved. I can simply say that, Novartis has taken this incredibly seriously. I've been on multiple conference calls. There are patients who are requiring care. There are protocols that are in the middle of the process. I've just mentioned, PSMA four, PSMA addition, both of them are halted right now. And you have patients on protocol, who are not able to get protocol treatment. This is a mess.


So I'm going to say, manage your patients as best you can. And this is, it sounds almost like a bit of BS, but literally, right before you and I are getting together, I had to run back to the clinic, to have a patient who's on the MAP program for Lutetium, who was initially responding, now is having dose delays. And I had to go back, and write him for some hydromorphone, and some high-dose steroids, and collaborate with my radiation oncologist to start some palliative care. So literally, the patients need care, even if the drug's not available. And even talk to him about the possibility of restarting some chemotherapy, even though they don't have great chemotherapy options. So the patients have to be managed, even if the Lutetium is not available. Hopefully, six weeks, but it's a little bit of a conjecture. I don't think any of us really know for sure. But it's awkward, very awkward.


Alicia Morgans: Well, I think acknowledging it is important. And thinking through, and as you said, treating the patients when they need to be treated. Keeping a close eye on patients, because they're aware, and they know that we don't have control, and nobody really has control here. We're all doing our best. But making sure that we meet the needs of the patients when they have them, as we wait for the availability of the drug, I think, is really important.

Oliver Sartor: Absolutely. And I think that's the message. Patients can't wait. They need our attention on an ongoing basis. And even when the best therapy that has been chosen for that patient is not available, you just have to adapt to the situation, and do what you can do. The patients need help, and that's the priority.

Alicia Morgans: Absolutely. Well, I sincerely appreciate you talking us through the implementation of this really exciting drug that has a recent approval, and some of the challenges that we're facing in this short period of availability issues. I always appreciate talking to you.

Oliver Sartor: Thank you, Alicia. Glad to be here.