Phillip Koo: 

Pluvicto is a new–is a drug that's been around for a couple of years. It's a radiopharmaceutical. We've seen ads about it on television. Most recently, the pool of patients that are eligible for this drug have increased, which is great.

But obviously it's not meant for everyone. It's meant for certain populations. But it's nice to see data continuing to come out regarding this treatment. And one of the pieces of data–one of the areas is around quality of life. What impact does this drug have on quality of life? Because that's, in many ways, just as important as that drug has on the disease. So can you tell us a little bit more about what we learned about quality of life? First off, how do we define quality of life? And what do we learn about quality of life with this drug?

Zachary Klaassen:

Yeah, absolutely. I think–just to give you a little more background– as you mentioned, Pluvicto has been around for a couple years based off the VISION trial. And this was men with mCRPC. So metastatic castration resistant prostate cancer, who had received an ARPI [editor’s note: Androgen Receptor Pathway Inhibitor].

So this may have been darolutamide, apalutamide, abiraterone, enzalutamide, as well as a chemotherapy, so either docetaxel or cabazitaxel, who then had a PSMA PET scan that had lesions that were visible, they were then eligible for Pluvicto. The most recent data was presented at ESMO 2024, called the PSMAfore study, and that was exactly the same type of men, but without chemotherapy beforehand. So we're sort of moving it a little bit more upstream in that mCRPC disease space.

And so what's exciting is that, as both of us know, and we'll share with our listeners, and they probably know as well, that at the end of March, we now have FDA approval in that new disease space of pre-chemotherapy for mCRPC for Pluvicto. And what's important, as you mentioned, quality of life is a huge aspect of my practice, because we all want to extend quantity of life.

But we also want to do that with the highest degree of quality of life. And so a lot of these big trials will certainly look at oncological efficacy of the treatment, but they'll also collect different metrics of what the patient's reporting, and I think this is important to sort of balance out. How much are we gaining? But at what cost to the patient's quality of life? 

And so Dr. Neal Shore, at AUA a couple of weeks ago, presented the quality, some of the quality of life data for PSMAfore, which was that second trial we talked about. What's interesting is that in this pre-chemotherapy space, not only are we having improvement in radiographic progression-free survival, which means the disease is not progressing on imaging, but it also improved time to pain–and also improved people that had pain, it got better. And I think that's important.

Another aspect in terms of that is the time to symptomatic skeletal-related events. And this is something that is a devastating event if it happens, and this is fracture, spinal cord compression, along those lines, from bone metastases. And this treatment also delayed time to that as well.

And so we're seeing that on top of people living longer and having disease–less disease progression, it's also improving pain in the people that have pain and decreasing the time to pain in those that don't have pain at the time of the trial. So we're seeing that combination, which is really encouraging, because, again, we want to improve quantity of life. But we also want to keep or improve quality of life as well.

Phillip Koo:

You know, that's a real encouraging message, and I think it provides, you know, even more optimism. You know, if a drug is actually becoming more effective, it's actually helping you live longer, helping you, you know, delay the time to which the disease progresses, and you–the way in which you can go about your life and go about your normal daily living is real encouraging. So just, you know, for the listeners out there, how is it measured? How is it sort of studied? And how do we know that it, you know, it is a real finding?

Zachary Klaassen:

Great, great point, you know, when people get enrolled in these trials, they do it–they do a baseline collection of data. So this is everything from all the demographic stuff, the prostate cancer aspects, but also they'll give them surveys. And these are validated tools to sort of assess quality of life.

And this would–this ranges from, you know, pain, physical activity, emotional, spiritual, sexual. All of these metrics are collected at baseline, and then they're collected at certain time points throughout the trial, usually every three months, give or take, on the trial. But then these are compared between the treatment groups and the control groups, and sort of delineating what changes are happening, not just at baseline, but over the course of that trial.

Phillip Koo:

Yeah, that's great. So you know, if there are any listeners out there who have been involved in trials, and even if you're not involved in trials, I think it's, you know, this is really good message. To be honest and open with your provider team with regards to what you're feeling and what's happening. And as you mentioned earlier, the caregivers are often the ones who bring this to light. But you know, patients need to sort of be honest and upfront as well, because this really has an impact on your treatment course.