Hi, warriors. Novartis says that Median overall survival with Pluvicto is 15 months (versus 11 months with SOC). So I think that means that 1/2 of men who use Pluvicto are still alive 15 months after starting treatment (or finishing treatment?).
But is there any data on how long men live beyond the 15 months? In other words, do those still alive at 15 months live slightly more than 15 months, or do some live 5+ years? Any data?
Thanks.
The statistical median is calculated by arranging the data from shortest O/S to longest O/S; and then determining the middle point.
In the absence of standard deviation numbers, you can simply examine how many participants were alive when trial ended to get an idea as to longevity
thank you. I guess I'm asking how long the men were followed. I have read what I can find but can't seem to find that.
I have not reviewed the Vision trial (which is ongoing); but according to its announcement for FDA approval, the therapy resulted in a 38% reduction of death. Extrapolating that information, if 30% of mCRPC live 5 years or more, you are looking at a significant statistical benefit from the therapy.
But where are you getting the part about "if 30% live 5 years or more." Is that actually true, or are you just constructing a hypothetical? If there is only a 38% reduction in death measured at 18 months out, then the benefit is minimal. Do you agree?
I don't see that in analysis. It looks to me like they only followed them for about 3 years. Can you point me to the figure or text showing 5 years?
Jersey: sorry, I took the statistic from the following
Good question. In Uk they are finally considering Pluvicto for approval in November. A statistically based answer would help support the case.
Hi Where did you hear about a pluvicto decision in November? That sounds like negotiations with the drug company have progressed?
Friday Sept 8 Times of London. “In November, Nice, the health watchdog, is expected to announce whether Lu-PSMA will be approved for NHS patients with advanced prostate cancer who have tried existing therapies.”
Doesn't say if they will though? Previously they had recommended against approval. Has anything changed to make us feel more positive?
I don’t know, only know what I read. Here is the link to the article :
Nuclear drug ‘to help 10,000 with advanced prostate cancer each year’
Hi, Jersy. These are absolutely great questions. I don't believe there is clear survival data to be found at this time. I think we will have to wait for a larger sample treatment sample size so that the statisticians can distill out the effects of adding Pluvicto to standard-of-care (SOC). This can seem to be a very slow boat for men with aPCa who want to find results that they can use to inform their treatments.
However, a more important term than "overall survival" is "radiographic progression-free survival (rPFS)" - this has direct use to me as a patient if I am considering/pursuing a treatment. As of December, 2022, Novartis has this information (see: novartis.com/news/media-rel....
In the U.S., it is the ultimate intent of Novartis that Pluvicto be considered SOC, e.g., considered on the treatment timeline as would taxane chemotherapy. NOTE: This intent is not only pushed by Novartis (whose motivations may be questioned) - my Radiation Oncologist firmly believes Pluvicto has a role earlier in the treatment timeline for specific cases.
However, the press-release says only vaguely that "(t)he Phase III data will be presented at an upcoming medical meeting and discussed with the US Food and Drug Administration (FDA) in 2023 for regulatory approval." I could not find any presentation. But, as always, stay tuned. - Joe M.
My husband is waiting for Pluvicto. Oncologist says he has 12-18 months to live; only half of that if he doesn’t use it. I KNOW everyone is different and these are only a doctor’s estimate, but I think it depends on how extensive your cancer is to start with.
I would like to see those numbers too. If it only would give me a few more months then why bother?
I thought the study data graph showed the survival endpoints were 7 to 22 months, median 15. In that case, the longest survivor was 22 months?
From what I can tell, all Novartis says based on the Vision study is that there is a 4 month survival benefit with Pluvicto (over best Standard of Care). But that modest survival benefit comes with a 36% risk of a serious "adverse reaction", which can include kidney failure. I agree that it looks like the participants were followed for about 22 months (not the 3 years I said in an earlier post), but it's hard to tell how many were alive at the 22 month mark. All we know is that 1/2 were still alive after 15 months (versus 11 months for best SOC).
There is a stronger case to be made for Pluvicto allowing men to feel healthier for a longer time (delaying things like fractures), but even then we are talking a matter of months. I wish there were more reliable interpretations of the Novartis data available because many men are spending tens of thousands to travel to get access to the drug. It feels as if by taking the drug we are study participants even though we did not sign up for the study.
I guess Novartis' statistics show that if you don't answer your phone after15 months you didn't make it..................Sort of like Aaron Rodgers and the Jets..........
Good Luck, Good Health and Good Humor.
j-o-h-n Tuesday 09/12/2023 4:19 PM DST
Just remember, you are NOT a statistic. They gave me the same kinda numbers when I started Xtandi. 70 months later I'm still kicking.
I think this goes the opposite way: overly rosy stats from a drug company…
I wonder if there any studies speaking to this most important of questions from Europe or Australia where theranostics have been in use for the better part of a decade. Five years next month since diagnosis, I am still hormone sensitive. Excluded from trials here because of earlier immunotherapy, I sought radioligand treatment in Austria this summer. First treatment 7/23 with actinium, 2nd treatment 8/23 with Lu-177. PSA 6/23, 180. PSA 8/30 23, 1.5. Concurrent use of Orgovyx begun 7/23. Dr. says Orgovyx increases PSMA expression and improves radioligand results even in those who have had previous hormone therapy (though in any case separating out effect of Orgovyx from Lu-177 would seem difficult). Have one more Lu-177 treatment scheduled for next week. Hoping for continued positive results after PSMA scan down the road.
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