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posted by martyb on Saturday April 18 2015, @09:37PM   Printer-friendly
from the smoke-'em-if-you-got-'em dept.

Two clinical trials for cancer were recently halted for the best possible reason; the drugs worked so well that it would be unethical to continue. One trial was for melanoma and the other was for lung cancer, but the drug-target was the same: Programmed cell death protein 1 (PD-1).

PD-1 is a protein that inhibits responses from T cells. Cancer often takes advantage of the PD-1 pathway to prevent a productive immune response that would otherwise kill the cancer. The drugs in both the clinical trials are antibodies that bind to PD-1, thus preventing cancer-mediated inhibition of the immune response. As this is a general mechanism that cancer uses to evade the immune system, it will likely be effective at treating other forms of cancer besides melanoma and lung cancer. Also, since the drugs are targeting T cells and not the cancer directly, resistance will not develop as easily.

http://pipeline.corante.com/archives/2015/04/17/stopped_for_efficacy_again.php
http://pipeline.corante.com/archives/2015/03/24/the_best_way_to_halt_a_clinical_trial.php
https://en.wikipedia.org/wiki/Programmed_cell_death_1

We looked around briefly and also found:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm
http://www.reuters.com/article/2015/03/24/us-merck-melanoma-idUSKBN0MK1FO20150324

 
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  • (Score: 2) by wonkey_monkey on Saturday April 18 2015, @11:18PM

    by wonkey_monkey (279) on Saturday April 18 2015, @11:18PM (#172630) Homepage

    Yes.

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  • (Score: 0) by Anonymous Coward on Saturday April 18 2015, @11:28PM

    by Anonymous Coward on Saturday April 18 2015, @11:28PM (#172633)

    Can you provide some citations, please?

    • (Score: 1) by btendrich on Sunday April 19 2015, @12:06AM

      by btendrich (3700) on Sunday April 19 2015, @12:06AM (#172650)

      I'm curious also. My father underwent a cancer treatment clinical trial a few years ago and my understanding was that the control group was not given a placebo, they just were treated per the "normal" protocol as opposed to the study protocol. At the time I was lead to believe that was how all cancer clinical trials worked, since it would be entirely unethical to withhold *any* treatment (give them a placebo), so the study was one treatment vs. another rather than one treatment vs. nothing at all.

      • (Score: 3, Informative) by frojack on Sunday April 19 2015, @12:31AM

        by frojack (1554) on Sunday April 19 2015, @12:31AM (#172663) Journal

        Yes, that's pretty much how it works now days. Nobody gets deprived of normal treatment.

        But halting the trial gives them the option of treating the control group with a regimen that they are already approved for (by virtue of being in this study).

        It does nothing for the rest of the cancer sufferers not enrolled in the study. Not until the drug is certified for general use.

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    • (Score: 2) by aristarchus on Sunday April 19 2015, @12:15AM

      by aristarchus (2645) on Sunday April 19 2015, @12:15AM (#172655) Journal

      No.

      • (Score: 0) by Anonymous Coward on Sunday April 19 2015, @02:04AM

        by Anonymous Coward on Sunday April 19 2015, @02:04AM (#172676)

        If you can't back up your claim then we have to assume that you're full of shit and lying.

        • (Score: 2) by aristarchus on Sunday April 19 2015, @02:32AM

          by aristarchus (2645) on Sunday April 19 2015, @02:32AM (#172686) Journal

          Maybe. Or just possibly you missed WonkeyMonkey's original answer.

        • (Score: 5, Informative) by wonkey_monkey on Sunday April 19 2015, @08:14AM

          by wonkey_monkey (279) on Sunday April 19 2015, @08:14AM (#172765) Homepage

          If you can't back up your claim then we have to assume that you're full of shit and lying.

          That's only if I can't back up my claim. If I simply don't, you're free to assume whatever you like.

          Not every statement absolutely requires a citation. If you asked me what the weather was like here, and I said it was sunny, would you go round demanding proof?

          My original "yes" response was just me being glib, based on the fact that, to me, the answer is, once stated, obvious enough to not really need a citation.

          Still, if you must have one, there's one in one of the links in the summary from David Young MD:

          The arm of the trial where the patients received the investigational drug did so well compared to the control arm (that received standard therapy) it was thought no longer ethical to withhold the investigational drug. As part of the trial design (and FDA regulations) the patients in the control arm were allowed to receive the investigational drug. The control arm patient were allowed to "cross over" to the investigational drug arm. In these situations, some of the patients in the control arm benefit from the investigational drug and it makes it very difficult to compare overall survival between the investigational arm and the control arm because some of the control arm patients ended up getting the investigational drug. In these settings it is the "progression free survival" that is much better in the investigational arm.

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          • (Score: 2) by wonkey_monkey on Sunday April 19 2015, @03:27PM

            by wonkey_monkey (279) on Sunday April 19 2015, @03:27PM (#172850) Homepage

            If you can't back up your claim then we have to assume that you're full of shit and lying.

            I just thought of a third option: I could just be mistaken.

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