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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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June 23, 2009

Medarex, Ipilimumab, Prostate Cancer, And Reality

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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 (34) + TrackBacks (0) | Category: Clinical Trials | Drug Development | Press Coverage | Toxicology


COMMENTS

1. p.philips on June 23, 2009 4:07 PM writes...

Very well said by David.
Ipilimumab 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

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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

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3. 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.

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4. Anonymous on June 23, 2009 6:45 PM writes...

any reference to where i can view this compound

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5. 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

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6. 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???

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7. 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'.

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8. 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

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9. 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.

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10. 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.

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11. 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

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12. 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 ...
+91-9813200770

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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?

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14. 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???

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15. Man Chan on July 8, 2009 1:52 PM writes...

My father got a advance PCa, how to join the clinical trial??

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16. 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

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17. 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

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18. 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

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19. 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.

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20. 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

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21. propo on July 10, 2009 1:21 PM writes...

p.s. to dave I should also have made clear that the aformentioned
parameters are only applicable after negative margins seen on the prostate gland after the radical prostatectomy. Without negative margins there is no "cancer free"

Permalink to Comment

22. John on July 12, 2009 2:01 PM writes...

have Pc gleason 6. how can I be treated with this therapy?

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23. 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 Comment

24. 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.

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25. 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

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26. 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

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27. 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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28. violeta on January 14, 2010 3:43 AM writes...

My brothet has melanoma. We are from Lithuania. Is it possible to buy ipilimumab? If so where and how much will cost. Thank YOU

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29. Jim Breitfeller on January 20, 2010 3:04 PM writes...

I will post some papers that I have on Anti-CTLA-4 Blockage Ipilimumab and Prostrate cancer on Melanoma Missionary

Permalink to Comment

30. Stella on February 2, 2010 7:25 AM writes...

My father has been offered the trial for Ipilimumab, however we are not sure if he will receive the drug or he might be given a placebo. My father is hesitant about doing the trial as he is concerned about the side effects. His cancer has spread from the prostate and has gone to the bone (hip) and lymph nodes. Has anyone used this drug and has it been effective and what side effects did you have? We are in Melbourne Australia

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31. Angelo on March 31, 2010 10:41 AM writes...

I have prostatic cancer. I'll have surgical operation in 15 days from now. I'm also doing hormonal treatment. How can I reach Ipilimumab?
Can you give and answer to me asap? thank you.
Waiting for your reply.
Angelo

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32. JWright on October 22, 2010 12:32 PM writes...

It's about time to stop thinking of androgen ablation as treatment for prostate cancer. It is so damaging to quality of life that the industry should be looking at anything else - and not in conjunction with this chemical castration.

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33. Rustyhoundog on October 9, 2011 1:17 AM writes...

The two men, subject of the Mayo press release, were not just prostate cancer patients, they were metastatic prostate cancer patients. The androgen ablation was used to encourage lymphocytes into the tumors. Ipilimumab was then used to block the CTLA-4 sites and start a massive lymphocyte attack on the tumors. There was B-cell involvement also; the tumors have never returned.
Claiming a cure for androgen ablation is ludicrous; it has never been seen before. It is the CTLA-4 block that produces the cures.

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34. Paul on October 15, 2011 3:29 PM writes...

so, two years later, what's the update on this drug?

is it really useful in treating metastatic prostate cancer?

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