Overview of 177Lu PSMA trials

[GP24]

Some forum members are looking for a 177Lu PSMA therapy. Here is an image of the available trials most of them are currently recruiting.

Novartis is offering the PSMAddition trial which is mainly for newly diagnosed high-risk patients with bone metastases. annalsofoncology.org/action... , clinicaltrials.gov/ct2/show... and the PSMAfore trial for metastatic, castration resistant patients who had Zytiga or Xtandi but no chemo yet. clinicaltrials.gov/ct2/show...

This image is from a recent article by Zhang et al. mdpi.com/2072-6694/13/16/40... Here is a link to the image in a bigger size: up.picr.de/42574912ge.png

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It is Fantastic of you to post this. 👍😎

[mperloe]

Terbium 161 is another upcoming option.researchgate.net/publicatio...

[GP24 in reply to mperloe]

Yes, but I understand that it is a problem to get that supplied. However, at PeterMac in Melbourne they start a trial with Terbium now.

prnewswire.com/news-release...

[mperloe in reply to GP24]

I heard that Novartis had an issue with Lu177 supply and had to freeze new trial enrollments in the US. I'm also looking forward to trials with FAP theranostics. Think globally, treat locally may be one a new strategy.

[GP24 in reply to mperloe]

There is a low SUV of FAP for prostate cancer. Therefore this therapy is used for different cancers but PCa. Lu177 and Ac225 are better alternatives than FAP. Here is an overview of the patients treated this year with FAP in one clinic. These patients had exhausted all approved therapies before.

up.picr.de/42576652wd.png

As you can see this includes just one patient who had neuroendocrine PCa. He died two months after getting the therapy.

[slpdvmmd]

Thank for putting this together. Suspect earlier will be better.

[GP24 in reply to slpdvmmd]

Prof. Sartor, a PI of the VISION trial, also thinks that the Lu-177 therapy will be used earlier. See the statement in the yellow box.

Slide by Prof. Sator at PROSCA 21 Meeting

[slpdvmmd]

I think one of the things to keep in mind about new drugs in the United States is the meaning of FDA approval. My wife has served for years on an expert panel for the FDA and she would be the first to say there is a profound disconnect between FDA approval and CMS or private insurance coverage. Once a drug or device is "approved" by the FDA then CMS and private insurers decide if and how they will cover it. Usually they look at the parameters of the studies submitted to the FDA for approval which are all to often late stage disease studies and decide to pay for patients who only meet these strict criteria. This is a fatal flaw of clinical trials and subsequent approval by each individual agency. Bottom line is patients outside what the insurer defines as the parameters for use in the patients insurance contract will need to appeal and be evaluated on an individual basis. A time consuming and often negative experience. In the case of Lutetium, while it is being used successfully much earlier overseas that is not what it will be approved by insurers for in this country would by my strong suspicion.

[GP24 in reply to slpdvmmd]

Prof. Sartor writes on the slide: "Trials now underway in chemo-naive mCRPC and also mCSPC". This are the PSMAddition and PSMAfore trials which I mentioned in my post. These trials are designed to gain FDA approval in these disease stages and thus to get insurance coverage for that. Novartis wants to get that revenue.

[joeguy in reply to GP24]

Have you heard anything about the LU177 supply problem that was mentioned above? I am interested in the PSMAfore trial, curious if there is any truth to it.

[GP24 in reply to joeguy]

I know that Ac225 is difficult to get but I am not aware that Lu177 is short in supply. However, due to Covid, there are many shortages and the demand for Lu177 is rising now.

[Javelin18 in reply to joeguy]

I’m being treated with Lu-PSMA under an early access program. I heard that it was closed to new enrollments by Novartis. There’s speculation as to why they closed program to new enrollments.

This is the first time that I heard of the supply issue, but that child be the reason. However, they will need a much larger supply after approval, so I’m surprised they are having supply problems before approval.