Dr. Jeremie Calais Discusses the Current Status of PSMA Diagnostics

In this GU Oncology Now sit down, Neeraj Agarwal, MD, Huntsman Cancer Institute, University of Utah, spoke with Jeremie Calais, MD, MSC, University of California. Dr. Calais discussed the future of PSMA PET imaging modalities in prostate cancer.

Neeraj Agarwal: So I’ll go back to you, Jeremie. We have heard about Gallium PSMA scan. Are there any other PSMA-based scans out there, and what our colleagues in the community should be looking at? What kind of PSMA scans may be available to them in the near future, in the next one year or so?

Jeremie Calais: Yes, sure. So PSMA PET can be understood as a class of imaging agent, or a whole imaging technique that encompasses multiple different PSMA-targeted PET stressors. You can do that with Gallium 68 PSMA-11, you can do that with Gallium 68 PSMA INT, you can do that with FAT and DCFPyL who is now FDA approved, available commercially under the name of PYLARIFY, you can do that with rhPSMA 7.3. You have an enormous amount of different PET tracers targeting PSMA.

All the ones that are pretty advanced in the clinical development are all performing very well. You still image this very high over-expression of protein in prostate cancer, you still get these impressive contrasted images. And so as long as you get a PSMA PET scan, it doesn’t really matter if it’s a Gallium 68 PSMA-11 or DCFPyL, or even others that are coming down the road, as long as your patient is getting some PSMA target assessment with PET imaging, you’re in the right spot. It is different than with, for example, ProstaScint, that was using the PSMA as a target as well, but using antibodies and the internal parts of the protein. So it was different. Here, if you do the external parts and you’re using this PET imaging agent, you’re in the right spot.

Many others are coming. I think I will speak to the ones that already approved, so Gallium 68 PSMA-11 was the first one approved manufacturer that UCLA and UCSF approved by the FDA. Then follows six months later in May 2021, the DCFPyL owned by now Progenics, then Lantheus, and this is a PYLARIFY. Blue Earth is finishing their phase three study and I’m sure they will run for a NDA pretty soon, maybe in the next year or so, something like that. Telix is still waiting for their final NDA approval, but I’m sure this will come in the next month, or again, in this type of timeframe. Telix has a kit. It is also Gallium 68 PSMA-11, so the same imaging agent that was produced at UCLA and UCSF, it’s just the way you produce it, the way you do the labeling is different. It is a kit, so it allows multiple sites to do this manufacturing process and that’s what they are looking for in terms of FDA approval.

So this is coming as well. And so at the end, what does it mean? It means that it will be widely and commercially available for almost anyone in the US within maybe one or two years, for sure, once the development and distribution network will be correctly set up. Another thing to put on the table here, as you said, whether it should replace or not either imaging modality. The NCCN guideline version 2022, that were just out in September, October this year, now has approved PSMA PETs, either DCFPyL or Gallium 68 PSMA-11, for initial staging, for recurrent, also for restaging [inaudible 00:04:09] resistant prostate cancer. And they say that you don’t have a prerequisite negative CT on bone scan to do the scan. You can benefit for from it upfront, replacing the other imaging modality up to now.

And last step, Medicare has granted us with the [CPH’s 00:04:29] code in October. So basically, Gallium 68 PSMA-11 is now covered by Medicare since October 1st and will cover as well DCFPyL on January 1st, 2022. So you’ll have approval of the FDA, you’ll have big industry vendors for commercialization and distribution network, NCCN guidelines, and now insurance coverage. So it will be widely available. And this question of availability will not be something left on the table to not do it. So, as we’ve seen here at UCLA, where we were providing a lot of discounts, a very rapid uptake from all the urologists, medical oncologists, traditional oncologists, that quickly changed their practice within a year, just relying on PSMA PET for every prostate cancer patients they have. That’s basically what we observe here at UCLA. And I’m assuming this will happen the same in the US within the next one, two years.