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The Best Way to Halt a Clinical Trial

These are words that you really like to hear: “stopped for efficacy”. That’s Merck’s situation with their anti-PD-1 antibody Keytruda (pembrolizumab), which was in a clinical trial in advanced melanoma patients versus Yervoy (ipilimumab), which targets CTLA-4. Couple this with the kinds of data that Bristol-Myers Squibb and others are generating, and PD-1 looks like it’s justifying its hype (which has been significant).
This antibody came from Organon, which was bought by Schering-Plough, which was bought by Merck, so it may be the main thing that Merck gets out of the whole deal. The cancer immunotherapy wave is showing no signs of breaking.

11 comments on “The Best Way to Halt a Clinical Trial”

  1. Anonymous says:

    I am glad at least a few people realize it came from Organon. With some bitterness I’d have to add it’s also the company from which no R&D is left anymore.
    In any case, some excellent people left at Merck and I wish them the best of luck with this antibody.

  2. Anonymous says:

    I met many exceptional scientists from Organon and from Schering-plough, both victims of their own success and now mostly scattered. I assume you are from Organon, and I hope at the very least you take some pride in advancing such an important therapy, even if the origin is sometimes lost to history.

  3. Anonymous says:

    Yes, I do and thanks for reminding me again the reason why all of us in the pharmaceutical industry should be proud for exactly that reason. Patients first!
    Back on topic, I remember all too well the history which shows how difficult it is to predict the right target or have any prioritization using complex metrics. Great news on the acceleration bringing it to the next step.

  4. Jeremy says:

    @1,3: what were the elements of the history (targets, prioritization) that made the progress difficult? I am interested to learn.

  5. Magrinho says:

    @1 – Agreed. I had the opportunity to work with Organon pre-clinical research and found them to be a smart, engaged, creative group.

  6. steve says:

    The checkpoint inhibitors and the CAR-T therapies are looking great in liquid tumors and melanoma but not so much in other solid tumors. There’s still a long way to go before declaring victory. Melanoma appears to be an exceptionally immunogenic tumor. The major tumors, breast, lung, prostate, pancreatic, etc. appear so far to be refractory to these modalities. There is a lot more to be done to understand how to apply immunotherapy to the major cancers.

  7. Anonymous says:

    And while Merck picks the fruits of Organon, it has nothing of its own worth investing in:

  8. Dan says:

    Once saw the Organon folks presenting the work on their reversal agent – Bridion as it is now known. A brilliant idea and a genuine innovation!

  9. Matt says:

    Funny how good news gets so few comments.

  10. Anonymous says:

    Sadly almost none of the PD-1 folks are left at Merck. Not the Organon / SP scientists, nor the Merck early R&D. (Merck had its own PD-1 mAbs, never put into the clinic because “immunotherapy will never work”. This was back in the Stephen Friend days when all cancer therapies would derive from the Rosetta gene profiling or not at all).
    Hopefully all these folks have landed well.

  11. bradpalm1 says:

    Steve: I think the oncology field is moving towards the understanding that using front end treatment modalities that provoke immunogenic cell death (ICD) such as radiation therapy, the anthracyclines, cyclophosphamide, HDAC inhibitors, T-VEC, Plasmid IL-12 and possibly other agents may be the key to inducing typically non-immunogenic cancers like breast, pancreas, lung and prostate to respond to back end PD-1 and CTLA-4 checkpoint inhibitor antibodies when used as combination immunotherapies.

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