FDA Grants Fast Track Designation for 177Lu-PNT2002 for the Treatment of Metastatic Castration Resistant Prostate Cancer

[Scout4answers]

Is this superior to the LU177 now available?

globenewswire.com/news-rele...

[treedown]

Isn't it just another company getting on the LU-177 bandwagon? Novartis has it as Pluvicto. This is a different pharma so I suspect that is the case.

[Scout4answers in reply to treedown]

certainly could be as I could not find any results of the SPLASH trial.

[swwags in reply to Scout4answers]

Per their own website -

The Phase 3 SPLASH trial is a multi-center, randomized, open label assessment of 177Lu-PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor therapy and refuse, or are not eligible for, chemotherapy. Participants were randomized 2:1 with those in arm A receiving 177Lu-PNT2002 and those in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility have the option to crossover and receive 177Lu-PNT2002. Patients are subject to follow-up for up to 5 years from their first 177Lu-PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall survival, overall response rate, and duration of response. Safety and tolerability will also be assessed. 

Apparently lower dose radioligand, fewer doses as well.

[Scout4answers in reply to swwags]

would hope to see a 90% response rate @ 5 years to justify a fast track status

[Fightinghard in reply to Scout4answers]

waiting 5 years is a long time. Not a fast track for sure

[cesces]

Good question

[Bkraus1]

Thanks for sharing, always good to learn of more options!!

[RyderLake2]

Hello Scout,

I think they are very similar. My understanding is that the radioisotope Lutetium is quite common and used by nuclear medicine doctors all over the world. The difference is in the radioligands which bind Lutetium to the PCa cells. Novartis has the rights to the PSMA-617 ligand which they market as Pluvicto. The SPLASH and ECLIPSE trials are using a different ligand. I know for a fact that POINT Biopharma is using the ligand PSMA-PNT2002. The reason I happen to know that is because I am enrolled in the SPLASH trial. There are several other ligands being developed. Hope that helps!

[Scout4answers in reply to RyderLake2]

I hope you will report what is happening with your trial

[Leader4077]

Where is your clinical trial and was it hard to get accepted?

[Gmailer]

treatmens.

[Gmailer]

Try going to India and have Dr. Sin at Fortis or Dr. Vaid I believe at Medanta. It's the same as Pluvicto. They do it on a certain day each week to make the ligand effective for you. Dr. Sin who has seen a couple of patients from this group charges about $20,000.00 for three treatments. They do everything for that price, bloodwork, and whatever scans you need. You need to have PSA positive in body for it to work.

[countrymusic101 in reply to Gmailer]

Dr. Sen is very knowledgeable and makes sure you are well informed of the procedure and it’s possible side effects.

[lokibear0803]

This is what I’ve found in my notes:

From urotoday.com/beyond-the-abs...

…use of small molecules 617 vs I&T (Imaging and Therapy, aka 177Lu-PNT2002) have been determined to be equivalent (June 2022)

From a previous HU thread, I think it was   tango65 :

…The ligand of Lu 177 PMSA I&T is smaller than the ligand of Pluvicto and it offers the theoretical advantage of a better penetration into the cancer cells. It seems that overall survival is not different than Pluvicto.

From urotoday.com/recent-abstrac...

PSMA-617 is preferable to PSMA-I&T … in terms of uptake and healthy organ sparing.