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New immunotherapy approved with potential for PC - Keytruda

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Posted 9/4/2014 10:12 PM (GMT 0)
Another very important immunotherapy just became available off label. Pembrolizumab (Keytruda) is a monoclonal antibody that blocks a cancer cell surface protein called PD-1. PD-1 prevents the immune system from attacking the cancer. While the FDA just approved it for malignant melanoma after "ipi" (Yervoy) failure, it can now be repurposed for advanced prostate cancer. I'm sure the cost will be sky high.

FDA approves Keytruda for advanced melanoma:First PD-1 blocking drug to receive agency approval

Specifically for prostate cancer, there is a clinical trial (NCT01420965) of an anti-PD-1 together with Provenge and low dose cyclophosphamide at Georgia Regents University in Augusta. They completed Phase I, which is antibody response to Provenge, and are just starting on Phase II randomization to the other treatments. They are about to expand to two more sites in Knoxville, TN, and Athens, GA, and are trying to find other sites as well. After 5 weeks of treatment, they have patients come in every 6 weeks for monitoring.

Another trial of Keytruda, this time coupled with another investigational immunotherapy called ADXS-PSA, has been announced but is not yet recruiting.
Advaxis and Merck Form Collaboration to Evaluate Investigational Combination of Two Novel Immunotherapy Candidates for Advanced Prostate Cancer
Posted 9/4/2014 10:48 PM (GMT 0)
There was an article about Keytruda in the WSJ today. They say that it will cost $12,500 per month or $150,000 per year.
Posted 9/5/2014 12:02 AM (GMT 0)
Several pharmaceutical companies have anti-PD-1 or anti-PDL-1 drugs in the pipeline. We can only hope that competition will eventually drive down costs.
Posted 9/5/2014 3:41 PM (GMT 0)
I think some kind of cost justification needs to be part of FDA approval...As it stands now, the drug companies can charge anything they want, regardless of development and manufacturing costs...Pricing Policy = Whatever The Market Will Bare..This will bankrupt our health-care system...

When a promising drug is developed, the first place you read about it is in The Wall Street Journal.....
Posted 9/5/2014 4:15 PM (GMT 0)
It's an interesting idea, but I can't imagine Congress voting to increase the FDA's role like that. Currently, its role is limited to safety and efficacy. Sometimes (but not often) it rejects new drugs that fail to show benefit over existing ones. The Center for Medicare and Medicaid Services (CMS) has the authority now to reject a drug for cost for Medicare/Medicaid, I think, but always rubber-stamps whatever the FDA approves.Private insurance companies may not agree to cover a medicine or treatment, or may make you jump through hoops to get it, but they generally have to have a good reason.

In the UK, the National Institute for Health and Care Excellence (NICE) plays a similar role to CMS in the US. They decide what the UK National Health Service may offer. However, NICE always considers cost-effectiveness and value for the money. They have so far rejected Jevtana and Xofigo on that basis for the UK NHS.
Posted 9/5/2014 5:34 PM (GMT 0)
I am astounded by the cost of these treatments considering they are largely palliative in nature and offer only a limited survival benefit or extension of life. There is a drug (sovaldi) recently approved for the treatment of hepatitis c at a one time cost of $84,000 in the US. The significant difference is that this drug cures the patient in 90% of the cases. If the Pca drugs offered a CURE then the price might not seem so rediculous or usorius when compared to the median income of just under $50,000 per annum in the US.

I am well aware that drug companies are in business and not charities but sometimes I think they lose sight of the human side of their business.

Don
Posted 9/6/2014 12:05 AM (GMT 0)
I agree with you 100% Don...Especially when one considers the drug companies spend far more on marketing
existing drugs than they do developing new ones..

I just think back to Jonas Salk and his Polio vaccine..Wiping out Polio in two years was far more important than everyone involved becoming millionaires..The kids got the shot free at school...
Posted 9/6/2014 6:38 PM (GMT 0)
Allen,

Thanks for posting this, it is very encouraging and I will be keeping a close eye on these types of trials!

The science behind it all is quite amazing. A "cure" is going to require a thorough understanding the enemy, and I think they are getting closer to that understanding. I really don't care what their incentive is to look for a cure, as long as they keep looking, then once they have one, we can debate what it is worth...

This may have been posted before, as it is an article from earlier in the year, but I found it to be a very educational on science behind Immunotherapy. It also shows the several companies involved in this therapy, and one can hope that competition will help contain the end cost... Pembrolizumab (Keytruda) was known as MK-3475 when this article was written. 

Role of Anti-PD-L1
Posted 9/7/2014 2:39 AM (GMT 0)
adjust,

The only conceivable benefit to HIV came because it vastly increased our understanding of the way the immune system works. That took a lot of funding from both the government and private sources. With all the government cutbacks into funding of basic research (NIH funding was cut back 5% and by 1000 researchers this year), I don't know if the past rate of progress will continue. Private companies just don't want to risk a lot on a new product that may not make it to market.

Today at the PCRI conference, I had a chance to speak to the man representing Prostvac-VF in the trial of it ±GM-CSF. I showed him my post about repurposing existing immunotherapies including GM-CSF. He said he would look at it and comment. He believes that immunotherapies will completely change the way we deal with PC over the next 5 years. It will be interesting to hear his comments.

- Allen
Posted 1/3/2015 4:37 PM (GMT 0)
Dr. Samadi and Dr. Siegel discuss this in a recent news segment on Fox:

www.foxnews.com/on-air/americas-news-hq/sunday-housecall#/v/3963227537001
Posted 1/3/2015 7:18 PM (GMT 0)
www.fiercepharma.com/story/opdivo-approval-bristol-myers-arms-pd-1-battle-against-mercks-keytruda/2014-12-22

Another PD-1 immunotherapy has been approved for melanoma, Opdivo / nivolumab from Bristol Meyers Squibb. It will compete with Keytruda.

Post Edited (robertC) : 1/3/2015 2:52:41 PM (GMT-7)

Posted 1/3/2015 9:22 PM (GMT 0)
This article may apropos:
www.bloomberg.com/news/2014-11-18/cost-to-develop-a-drug-more-than-doubles-to-2-56-billion.html

I'm not sure if that cost also includes the number of drugs that don't make it through trials to market. Couple that with eventual manufacturing costs and at least reasonable profits, and it's a staggering amount of money.

Divide that by the number of patients receiving them, and the per-person cost may actually be rather high. (For example, $2.56 Billion divided by $93,000 per patient for Provenge says they need to sell over 25,000 treatments without ANY per-treatment costs or profits just to recover the development cost.) Net out the "manufacturing" costs for each treatment, plus even a reasonable profit margin, and the number of treatments required goes even higher.)

The idea of cost for cure vs. cost for say another 4 months of survival is a great observation. I wonder if there's a value one can place on a day of life? How can one decide such a thing? Is it simply a cynical cost calculation, that my potential future earning possibility justifies a certain "repair" expense, or if one is retired then they're just a societal cost and not worth continuing? I hope it never comes to that. But still, a million bucks for a cure, or a million bucks for 4 more months? If it's MY 4 months? Hmm...

My sister's a pharmacist in a hospital setting, and I asked her a similar question. Do they ever consider whether a patient is a good long term bet, and thus worth heroic measures, or are they so close to end of life that it's not worth the cost? She said they do have discussions with groups of doctors like that in the hospital. Not the "death panels" that some cynically predict, but a compassionate discussion about how much more treatment is really worth doing. For most of us there must come a point of diminishing returns.

Jerry
Posted 1/3/2015 9:32 PM (GMT 0)
This is certainly an interesting and valuable discussion...and a difficult one to have. It's a fact that something like 75% or more of a person's lifetime medical costs are paid in the last year of life (various groups have various stats, but it's a sobering reminder of the cost of end-life care.) If dollars are truly limited, then conversations about the best way to spend them are important to have, no matter how difficult.

I pose this very real (I saw it with my own eyes) question: You have two patients. One is 9 years old, with highly treatable non-hodgkins lymphoma. She's going to need a year of advanced chemo and/or radiation, and has a better than 90% chance of living a full life once in remission. The second is a 90 yr old grandmother who develops late stage colon cancer. She's very frail, and during her cancer treatment, has a fall and breaks her hip. At what point do you say, "stop it and let her die"? Given the choice (both actually got treated. The little girl is now about 14 and doing great, the elderly lady died a few weeks after hip replacement surgery) who would you treat?
Posted 1/3/2015 10:04 PM (GMT 0)
Maybe a new thread Halbert, so as not steal Allens.

I'd pose the question to the 90 year old.

Cheers, Doug
Posted 1/3/2015 10:29 PM (GMT 0)
thanks shaba...maybe I will (post the thread)
I do agree, the insane cost of new, potentially life-saving drugs is a major problem. It's really a political question, and one that our current embodiment of a system is unable to talk about.
Posted 3/25/2015 10:46 PM (GMT 0)
In a randomized comparative trial of Keytruda vs. Yervoy for melanoma, they stopped the trial early because there was such a significant advantage already to Keytruda. At this point, we don't know for sure that it will be effective against mCRPC, but it is a good bet. If any of the clinical trial sites are within driving distance for you, I recommend you look into it.

KEYTRUDA Demonstrated Superior Overall Survival and Progression-Free Survival Compared to Ipilimumab

And here's the best clinical trial I've seen for it:

Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer

- Allen
Posted 8/1/2016 3:30 PM (GMT 0)
A minor clarification: the PD-1 protein is found on the surface of T cells, not cancer cells. Cancer cells have the PD-L1 protein on their surface.

Clinical testing of PD-1/PD-L1 checkpoint inhibitors continues apace. The recent NYT articles on immunotherapy for various cancers provides additional information. Best to all.
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