Ashish Kamat: A warm welcome to all of you from the UroToday studios. I'm Ashish Kamat, Professor of Urologic Oncology at MD Anderson Cancer Center in Houston, Texas. And we are live at AUA 2025 in Las Vegas. It's a great pleasure to welcome to the studios Dr. Patrick Soon-Shiong, who really needs no introduction. Patrick, thank you so much for taking the time. And welcome.

Patrick Soon-Shiong: Thank you. Thank you for having me.

Ashish Kamat: So there's so much that we can talk about, right? You've been out there. You've been on Tucker Carlson. This is not Tucker Carlson, but we want to hear everything you have to say. And we'll focus on bladder cancer to start with. So tell us about what's going on in the bladder cancer world when it comes to the recombinant BCG that you're bringing to the US.

Patrick Soon-Shiong: Well, Ashish, this could be the Tucker Carlson, I think. No, seriously, though, having said that, the reason I went on the show, it's really important now for somebody to stand up and speak to the science. You hear so many things out there that are not only confusing to the patients, to the community, to the nation, even to the academics, and even to the regulatory bodies. So this kind of forum that we're having is probably one of the most important forums. I'm going to do more of these now.

I think it's a real important obligation for me, where there's really no axe to grind other than to share the science that's in the best interest of the patient. I was honored to give this keynote address yesterday, where young urologists, young doctors that are entering into the field, we really need to speak. And I closed the talk by saying, never give up, fight dogma, follow the signs, follow your passion, have conviction of your thoughts, but do everything on behalf of your patients. There's no other interest to be considered other than that your patient.

Ashish Kamat: And that's something you've exemplified by all the work, and the research, and what you've done getting these drugs to be available for our patients. So thank you for that. And I also like what you said about this is something that we need to share with the patients because, ultimately, it's our responsibility to the patients, right? And BCG has been in short supply in the United States, many parts of the world. And it's really refreshing to see the efforts that you've put in to get BCG from the Serum Institute of India through the FDA here, but not many people know about it. So share with us a little bit.

Patrick Soon-Shiong: Well, I think that's one of the most important subjects for us to discuss, especially with our urologists now that use BCG and the TICE BCG, which has been the standard in the United States from Merck and has been a great shortage, unfortunately. So 57% of patients who could benefit from the BCG were not available to have it. And so we've solved that problem now with Serum Institute.

But I think the more important thing for me to share with you is not just that we solve the shortage problem, that this is, I consider, and we talked about that as a supercharged BCG. So what do we mean by that? The last year when we presented ourselves to the AUA with ANKTIVA approved, it was combined with BCG. And the importance of that combination is that BCG is immunogenic, meaning a good thing. It actually stimulates the CD4 and CD8 T-cells and NK cells.

But it goes away. This BCG, being a supercharged BCG-- and we can go into the science of how and why they supercharged-- is not only potent in terms of stimulating the immune system. There's data now showing four-year absence of recurrence of over 40% of patients. That's unprecedented with BCG alone. So we can talk about why this is important, but more importantly, the FDA has now given us access through the expanded use approval.

And the good news is that our label of ANKTIVA doesn't stipulate TICE BCG, just BCG. So we are now making this available to the country. And we can talk about why BCG versus chemotherapy, but that's the BCG we want to discuss with you today.

Ashish Kamat: And we've had Cyrill Rentsch, who published on this many years ago, on UroToday, and we talked about the data from that publication. But I'd love to hear your insights, a deep dive into the immunotherapy behind it. So if you could just shed light for our audience that is listening, short, how do you think the supercharged BCG is going to actually interact with the NK, the IL-15, that story?

Patrick Soon-Shiong: What they've done, you saw in that publication. So you see this validated result now of four-year non-recurrence of the BCG. And you ask yourself why. What they've done, because it's recombinant, they could actually modify that BCG with yet another protein, called Listeria, that actually activates even further the immune system. So it's a recombinant engineered BCG that is grown. We can have now quasi and almost an unlimited supply because it's recombinantly-grown for the country.

But more importantly, it is potent in its activity. And even more importantly, it appears to have less toxicity versus the current BCG that's made by TICE. So it has these double advantages that has never been able to be perpetuated in this country because nobody's been able to bring it in. And as I said, I'm really grateful for the agency now for us to make it available to the entire country.

Ashish Kamat: So tell me a little bit more about the availability. What does one have to do to be able to get it under that program?

Patrick Soon-Shiong: Right. So we applied what we call expanded access. And because our label just says BCG, it doesn't say TICE BCG, the FDA authorized it. So there's different levels of authorization, intermediate and then large scale. We started with intermediate. We're going to the large scale, which means thousands of doctors or institutions. So all the institution has to do is literally sign up one IRB, period, that's it, and the BCG becomes available for any of the patients in their standard of care when they combine BCG, whether it was BCG in the naive setting, whether BCG in the papillary setting, BCG in the CIS setting.

And obviously, our label is for the CIS setting as we speak now. So it's a very simple process. Sign up a single IRB. We have a central IRB already approved. And many institutions, large institutions, have already signed up. And we begin to roll this out.

Ashish Kamat: Every time you sit down and we chat, I learn so much from you. And our audience does, too. Thank you so much once again for taking the time.

Patrick Soon-Shiong: You're welcome. Thank you for having me.