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June 23, 2009
Medarex, Ipilimumab, Prostate Cancer, And Reality
Posted by Derek
What's really going on with Medarex and ipilimumab? The company made news over the weekend with a press release from the Mayo Clinic, detailed what appears to be a substantial response in two prostate cancer patients. But the more you look at the story, the harder it is to figure out anything useful.
As this WebMD piece makes clear, this study is not a trial of ipilimumab as a single agent. The patients are undergoing prolonged androgen ablation, the testosterone-suppressing therapy that's been around for many years and is one of the standard options for prostate cancer. The trial is to see if ipilimumab has any benefit when it's added to this protocol - basically, to see if it can advance the standard of care a bit.
WebMD quotes Derek Raghavan at the Cleveland Clinic as saying that androgen ablation can sometimes have dramatic results in patients with locally advanced prostate cancer, so it's impossible to say if ipilimumab is helping or not. That's why we run clinical trials, you know, to see if there's a real effect across a meaningful number of patients. But (as this AP story notes) we don't know how many patients are in this particular study, what its endpoints are, or really anything about its design. All we know is that two patients opted out of it for surgery instead. (Credit goes to the AP's Linda Johnson for laying all this out).
Ipilimumab is an antibody against CTLA-4, which is an inhibitory regulator of lymphocytes. Blocking it should, in theory, turn these cells loose to engage tumor cells more robustly. (It also turns them loose to engage normal tissue more robustly, too - most of the side effects seem to be autoimmune responses like colitis, which can be very severe. The antibody has been studied most thoroughly in melanoma, where it does seem to be of value, although the side effect profile is certainly complicating things.
So overall, I think it's way too early to conclude that Medarex has hit on some miracle prostate cure. This press release, in fact, hasn't been too helpful at all, and the Mayo people really should know better.
Comments (27)
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1. p.philips on June 23, 2009 4:07 PM writes...
Very well said by David.
Permalink to CommentIpilimumab was given in combination with hormones
(antiandrogens).Androgen ablation is known for over 60 years to supress cancer of the prostate.
On some patients the responce can be dramatic.So, we can't come to conclusion that Ipilimumub cures the cancer.Besides, according to Mayo Clinic report, the two patients that had excellent results from this drug were part of a trial involving 52 more patients.
While this drug is encouraging , we need double blind studies on more patients and long follow-up
2. trader on June 23, 2009 4:16 PM writes...
but it could do wonders for MEDX (NASDAQ) that is after all, what it's all about
Permalink to Comment3. Patrick on June 23, 2009 6:30 PM writes...
The real issue here is that there is a growing list of new treatements such as abiaterone, ipilimumab, and provenge that offer hope to PCa patients who previously had little or no reason for hope.
And while chemical castration is a first line of treatment for many stages of disease, no one would ever opt for it should any reasaonable alternative treatment become avalable.
Despite an N = 2, it is nothing short of amazing that both patients are now cancer free.
Permalink to Comment4. Anonymous on June 23, 2009 6:45 PM writes...
any reference to where i can view this compound
Permalink to Comment5. Tatiana on June 24, 2009 3:04 AM writes...
My husbant has canser prostata 4 stady. How is it possible to get for treatment to this clinic. Thanks. Tatiana. + 7 (495) 725-89-07
Permalink to Comment6. kate b on June 24, 2009 9:55 AM writes...
Does anyone know how old these patients were?? My husband 42 and has been diagnosed with adnaced prostategleason score of 9...i would try anything any links to where these trials are run from ...us only???
Permalink to Comment7. pez on June 24, 2009 10:28 AM writes...
http://www.clinicaltrials.gov/ct2/show/NCT00170157
"A total of 108 males with advanced prostate cancer will be enrolled into this study. Patients must have undergone prostate cancer staging within 180 days of enrollment. 54 patients will be randomized to receive hormone therapy alone and 54 patients will be randomized to receive hormone therapy plus the MDX-010 therapy."
If all the MDX-010-responding patients come off the trial to get surgery, the trial cannot meet its endpoint: 'Primary endpoint will be the proportion of patients remaining progression-free'.
Permalink to Comment8. davide on June 24, 2009 10:57 AM writes...
What the prior post left out was the exclusion criteria:
Participants may not have underwent prior systemic chemotherapy or prior radiation therapy to the prostate. Includes post radical prostatectomy patients with a rising PSA and patients who have started hormone therapy ≤21 days
Permalink to Comment9. anthony on June 24, 2009 7:09 PM writes...
it is possible to buy this medicine to try out Ipilimumab for prostate cancer? if so how much will cost.
Permalink to Comment10. CMC guy on June 24, 2009 11:52 PM writes...
If a pharma company made a similar "startling" announcement it would likely get a direct warning from the FDA but coming from Mayo Clinic (or other academic source) its seems routinely acceptable to make pronouncements of success without details or significant corroboration.
Permalink to Comment11. Andrzej Tarasiewicz on June 25, 2009 4:43 PM writes...
Patient in Poland has canser prostata . How is it possible to get for treatment to this clinic. Thanks. Andre tel:+48602113571
Permalink to Comment12. kanwardeep singh on June 29, 2009 6:17 AM writes...
Sir ,
My father has been diagonosed with advance prostate cancer with gleason 10 , he underwent on hormone therapy , pls tell how to enrol for clinical trial , its my sincere request being outside Us pls hel me ...
Permalink to Comment+91-9813200770
13. WERU JOHN on July 1, 2009 9:21 AM writes...
It would be the best thing to ever have happened to patients with cancer of the prostate the incidence of which is increasing and the age reducing.It is prudent that we know how ipilimumab would work alone without hormonal ablation, why only 2 patients showed that improvement out of 52.We need R.C.Ts, double blind studies etc.Being an antibody drug, it is bound to cause serious side effects.Any that were observed?
Permalink to Comment14. rose on July 7, 2009 6:27 AM writes...
Is it possible for Ipilimumab to treat Breast Cancer? If Yes, where can we buy the drug???
Permalink to Comment15. Man Chan on July 8, 2009 1:52 PM writes...
My father got a advance PCa, how to join the clinical trial??
Permalink to Comment16. propo on July 8, 2009 6:26 PM writes...
Lest you forget. The Urology Dept. at Rochester Mayo is headed by the premier Radical Prostatectomy surgeon in the world, now that Patrick Walsh from John Hopkins is retired. Any study coming from that Dept. even if he is not directly involved has to be taken very seriously. This leak of 2 patients was an inter-departmental communication but 2 men who were so crippled with pain that they couldn't walk, are now cancer free. Lets all pray that Mayo and ipilumumab are the real deal
Permalink to Comment17. Aimee on July 10, 2009 2:47 AM writes...
My Dad as well has prostate cancer he's young and is having hormone treatment. Has been given 2 to 3 years to live. I want to find out about these trials. he is keen to try them even travel to the US. We are in New Zealand
Permalink to Comment18. Aimee on July 10, 2009 2:47 AM writes...
My Dad as well has prostate cancer he's young and is having hormone treatment. Has been given 2 to 3 years to live. I want to find out about these trials. he is keen to try them even travel to the US. We are in New Zealand
Permalink to Comment19. Dave on July 10, 2009 11:58 AM writes...
As usual, more hype than truth. What determined that the patients' tumors could not be operated on? Usually that is only the case when cancer has spread beyond the prostate.
Also what determines "cancer free". I am now stage 4 after having a PSA of .01 after initial treatment with Lupron.
Too bad the media, including the Today Show, climb all over this crap.
Permalink to Comment20. propo on July 10, 2009 1:15 PM writes...
to Dave, Cancer free at Mayo means Psa0, negative mri, and negative bone scan. But as any person who has had cancer knows it takes 5 full years from achieving these parameters until one is "truely free" of any cancer
Permalink to Comment21. propo on July 10, 2009 1:21 PM writes...
p.s. to dave I should also have made clear that the aformentioned
Permalink to Commentparameters are only applicable after negative margins seen on the prostate gland after the radical prostatectomy. Without negative margins there is no "cancer free"
22. John on July 12, 2009 2:01 PM writes...
have Pc gleason 6. how can I be treated with this therapy?
Permalink to Comment23. Jim Breitfeller on July 12, 2009 9:07 PM writes...
Derek, If you knew the science behind ipilimumab, it is the "Magic Bullet". But it must be used in concert with IL-2. See, I Know because I am a stage IV Melanoma Survivor/Researcher. I worked for Eastman Kodak in their Research labs for 25 yrs. until I came down with cancer. I have studied my therapy and have written a paper on it. It is backed by scienctific journals.
If you would like a copy, Just email me at
dbreitfe@rochester.rr.com
You won't be dissappointed.
Jimmy B.
Permalink to Comment24. talson on July 16, 2009 3:15 AM writes...
If any one interest in the drug or want to participate in the clinicaltrial. See the link and the recruit location (international)
http://www.clinicaltrial.gov/ct2/show/study/NCT00861614?term=ipilimumab&rank=31&show_locs=Y#locn
If any one doubt about this drug can do for cancer.. just search or visiting melanoma and see how many melanoma patients are grateful with this drug. But currently, this drug is hot and not available.. except in specific study only.
Permalink to Comment25. anthony on August 20, 2009 10:13 PM writes...
is it possible to buy ipilimumab? if so where and how much will cost thank u
Permalink to Comment26. anthony on August 20, 2009 10:13 PM writes...
is it possible to buy ipilimumab? if so where and how much will cost thank u
Permalink to Comment27. diane on September 15, 2009 3:02 PM writes...
I looked on the website, thanks for posting it, Talson. ..my husband is also stage 4 as the cancer is in his hip bone. The trial requires that participants have chemo treatments before you can be participate in the trial. My husband is on lupron only. I guess we have to wait until his PSA goes up again and he has the chemo.
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