Don't get this about Provenge

For all the talk I have heard about the new "breakthrough" PC fighter Provenge, doesn't look like it offers much survival time, and I understand it is ungodly high in price.  I am missing the obvious again.  I paste a quote from an article that talks about "improved" survival time using it, doesn't seem it would be worth the cost or effort if this is all it offers.  Got to be more to the story.

"One such treatment that is now available, PROVENGE® (sipuleucel-T), was shown to extend median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months)"

David in SC

David,
An increase in survival time of 4 months is considered very good in any advanced cancer. Many patients don't respond at all to provenge and their score is 0 so to get an average of 4 months many patients have to survive much longer than 4 months.
What we don't know about provenge is that how it works on less advanced PC as all the trials were conducted on patients that had already gone refactory.
We knew Provenge had an advantage way back in 2003 and it took another 7 years just to get it approved for only advanced PC.
It does cost $90k; but this is cheap in relation to most other Chemo Therapy for other cancers which is usually $100 to 200K for a treatment course.
JT

It's $31,000 for each of the three treatments, Medicare and most insurance companies will pay for it, although the same dirty politics which has/have plagued this treatment from the beginning still plague it and "Medicare won't pay for it unless it was in pill form" is incorrect.

Although my insurance company didn't pay anywhere near those amounts, my last two chemo treatments (Taxotere) and their side effects were billed at $40,000 and $19,000. There's nothing wrong with $93,000.

Is $40,000 for sitting in a recliner for an hour worth it? How much is your life worth to you?

Post Edited (Gordy) : 11/27/2010 7:57:44 PM (GMT-7)

You stand corrected on the survival time, too. 4.something months is the median time - some guys have survived for years.

Getting chemo, for the most part consists of sitting in a recliner for a certain period of time with a needle in your arm. How much is that worth?

I think you should write to Mitch Gold, CEO of Dendreon and tell him what you think of his business practices and his concern for humanity.

Seems to me the excitement about Provenge is that it extends life by ANY measurable amount.
To those with 4 mo left, 4 more months is another lifetime. But that's not the point.
HOW does it work? How can what works about it be bottled, refunes and improved. If given as initial treatment when patients are otherwise healthy, perhaps 4 months adds up to 4 years. 4 turns into 8. They using a group of patients who are in tough shape to begin with..close to passing.. you really cant expect a drug to solve EVERYTHING at that stage..

Re price, company spends hundreds of millions it does need to make a profit when it comes up with a successful result. They could have 50 other hundred million drugs that make them nothing. Otherwise there is no motivation for them to try. Then we're all screwed. I understand that much of the expense for this 'treatment" is that removing and adding blood.. and not simply about the drug itself.

If you can find a substance that delays the effects of PCA in the worst case patients like this... that might just be the start. Combined with other treatments in the pipleine. I have hope.

I am particularly excited about this XL184. Understanding all the qualifyers, the preliminary stage, the minute number of patients, STILL, 19 OF 20 OF THE WORST CASE PATIENTS BENEFITED.

Consider this statement/result:
"The most important finding was the complete or partial resolution of bone lesions in 19 out of 20 evaluable patients with bone mets. This finding by itself, which is preliminary and should be corroborated in larger studies, could represent a breakthrough in the treatment of prostate cancer."
http://seekingalpha.com/article/238374-promising-data-puts-exelixis-back-on-track

Happy and safe holidays.

Bob,

Thanks for the insight and the info on the xl184. I have since researched it (never heard of it before), almost sounds too amazing with some of the outcomes with not only PC, but other hard to stop cancers. Wonder how long it will take to get it to the market?

David

Dave, I dont know how long it wIll take, I'm not sure "we" (PCA patients) have a loud enough voice out there to effect policy.

WHO IS IT THAT SPEAKS FOR US? ARE THEY ON THIS WEBSITE? DID 'WE' DECIDE WHO THAT WOULD BE? IF THERE ISN'T AN INDIVDUAL ENTITY, WHY NOT?

I know this, if you can find a situation where 19 of 20 patients of any kind show progress from a disease than can kill them - SOMEBODY better get up and say very clearly "GET THIS FRIGGEN THING SPEEDED UP!"

I think currently it is simply market forces that will drive it..as the story states, just this past July Bristol-Myers Squibb decided to pass on codevelopment rights. Let's hope they regret that decision forever. Not because I have anything against them, but because that will mean this drug can save countless lives.

David,
I think the cost involved in developing a new drug is so staggering with all the trials, hearings and liability involved that in order to recoup development costs and the costs of developing all the other drugs that didn't work or make it to market a high price must be charged.
The process of Provenge is also quite different that other drugs in that a special facility must be built to process the patients blood in which imune cells are added.
Seeing all the expense that getting the Combidex imaging agent approved and having the manufacturer discontinue it because of the approval time and expense woke me up to the other side of bringing a drug to market. We also have to be aware of all the political considerations and the lobbying by interests that would be replaced by the introduction of any new drug or procedure.
There are a lot of road blocks to the introduction of a new drug, and why is provenge not being tested on less agressive cases?

JT

Purgatory:
I think you raise some valid points. If half of the men on Provenge survived less than four months longer than the placebo group, yet all of the men paid the equivalent of 93,000$, where is the value calculation? In addition, the men who benefitted in survival continued to suffer from pain and other symptoms since Provenge had no effect on the progression of the disease. Also many of the men treated with Provenge on the trial went on to taxotere chemo therapy during the remainder of their life, with such loss of quality of life as it entails.
In my mind the real benefit of Provenge lies in two areas: There are some men in whom Provenge creates a robust immune response, somehow highlighting the cancer cells to be attacked by any later treatment, as well as the immune system itself. These men will have the greatest benefit range among those on the trial. As in all cases, the median is not the message. The range is a large part of the story. Pattersson alludes to this. The other area in which Provenge may well show great benefit is in earlier disease stages. At first recurrence, at first sign of metastasis or anywhere along, Provenge may show a greater survival than four months. Any such greater survival becomes easier to justify compared to the cost.

JohnT - you brought up some good points, even though my whole life has been in the biz world, I was acting from the heart only on this subject. You are quite right about the costs and hassles of bringing any drug to the market here in the US. And we all know that the drug firms are non-profit entities.

pattersson - your point is well taken too, median means just that.

tar - you brought a good perspective to the subject as well, thanks. thinking about the chemo phase of PC is new ground for me, just now thinking about and trying to get a handle on that whole world. None of it sounds good to me.

If $93,000 bought you 4 months, and that 4 months allowed you to take the XL184, and the XL184 removed the cancer from your bones, you'd probably think the $93k was well spent. When the price becomes $46,500 and they effecte is doubled, it will be bettwer spent. But it's a start.


Millions of people have walked away from half million dollar mortgages in the past 2-3 years. "Cost" is relative.

Numvers are funny, "PROVENGE® (sipuleucel-T), was shown to extend median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months)" ..

That sounds to me like PEOPLE WHO TOOK THE DRUG LIVED 20% LONGER.

Reminds me of the " A billion here, billion there, before you know it were talking serious money"..
4.1 months here, 20% there, 19 of 20 over there, before you know it, your talking significant time in someone's life.

And then you're talking significant time in alot of people's lives.

My warm thoughts to all of you!

Bob from Cape Cod.

Jerry, that's the $64,000.00 question.

We don't know. All cases that led to the drugs approval were mostly refractive of not just hormonal therapies, but also chemotherapy. Like Abiraterone, Provenge may be even better when used earlier. We will have to await those studies to make us feel feel better about our blind faith. But it certainly looks like these will be able to help in the early stages as well...


Tony