Home Forums Melanoma Diagnosis: Stage IV New BMS Trials for Anti PD1 opening

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  • #20753
    Catherine Poole
    Keymaster

    Two Phase 3 trials for anti-PD-1 have now been posted to clinicaltrials.gov, including:

    Study -037: A Study to Compare BMS-936558 to the Physician’s Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy

    http://www.clinicaltrials.gov/ct2/show/NCT01721746?term=bms-936558&phase=2&rank=1

    Study -066: Study of BMS-936558 vs. Dacarbazine in Untreated, Unresectable or Metastatic Melanoma

    http://www.clinicaltrials.gov/ct2/show/NCT01721772?term=bms-936558&phase=2&rank=2

    #57426
    alankravitz
    Participant

    Thanks for the rapid update. It’s about time BMS announced Phase 3 trials and it is good to see that they seem to be international in scope.

    I’m most concerned about the lack of any provision for crossover for participants not receiving the anti-PD-1. There is already a great deal of data on drugs in the other arms and, since they are looking at the presence of PD-L1, they would be able to target participants.

    I remain concerned about the cost side of the cost-effectiveness equation. Current international cancer drug pricing policy is clearly based upon our domestic reimbursement mandate. It is causing delays in many countries and has created a situation where we are paying more than those countries where there are approved patient access schemes. I would like to see the entire cancer community sit down to address this issue before it becomes a part of the inevitable larger debate on cutting health care costs. I know that you have heard it from me before but how about an MIF Forum on Health Policy and Melanoma?

    #57427
    Catherine Poole
    Keymaster

    I agree, the lack of crossover is very troubling. They said because the endpoint is overall survival they can’t allow crossover.

    I agree Alan about the needs of the global community, but we have limited resources and really focus on individual patients with our time, and funding. This would be a large project that we would need many partners to collaborate.

    #57428
    alankravitz
    Participant

    They should have access to plenty of overall survival data on Dacarbazine. What is the point of the placebo cohort other than to let patients die. I thought that thinking about the design of clinical trials had gone far beyond what is represented here. I know that patients want access to anti-PD-1 but it seems as though the design of Study-066 is stacked against their best interests.

    Alan

    #57429
    Anonymous
    Guest

    Good points Alan and Catherine!

    There’s decades of “run data” for dacarbazine so why do you need more of the same for comparison. Just take a lot more samples with the PD1 and save more people in the process.

    If you want to make comparisons, do it with IPI, which to me is becomming the new standard for non-Braf tumors.

    Now that you’re in phase III trials, if I were BMS, I’d be looking really hard at combinations of PD1 with IPI and start taking that data now since IPI is readily available and a large segment of patients who’ll get PD1 when it’s approved will have had IPI.

    Just some thoughts.

    Jeff

    BTW, it’s still really, really, really good, excellent news that PD1 is moving thru the trial process “quickly” now. Really good news.

    #57430
    Catherine Poole
    Keymaster

    So here is a theory: by using dacarbazine and taxol/carbo they will quickly see the benefit of PD1 and approval will come faster. I am trying to find out more but terribly discouraged by this trial process.

    #57431
    Catherine Poole
    Keymaster

    Here’s the answer to the trial design, it is to meet the Global regulatory requirements, i.e. Europe and Australia.

    #57432
    Catherine Poole
    Keymaster

    Here’s a little update on these trials. Because the overall survival advantage of the PD1 is the endpoint of the trials, they are giving the patient and doctor choice of chemo (dacarbazine/taxolcarbo) if they are randomized to this side of the trial. We’re hearing 30% for the response rate for PD1 but we don’t know overall survival in contrast to older therapies. The possibly good news is that 2/3 of the patients will get the PD1 and only 1/3 the chemo. It is a large study globally with 800 slots I believe. There will be a third study introduced in the new year. The one study is a first line study and the second a second line. Half will be IPI refractory (no response to IPI) and the other IPI naive (never had IPI)

    #57433
    jeffstark
    Participant

    Hello,

    Does anyone have a pdf version of the research paper Next generation of immune checkpoint therapy in cancer: new developments and challenges? It was published in 2018 (the BMS-986016 was tested too), if I’m not mistaken. Unfortunately, I cannot find the pdf online. I’m studying various inhibitory checkpoint pathways and need to use the statistics from this article.

    Sorry for bumping.

    Jeff Stark – IntelligeneCG group

    term paper writing service[/url][/size]

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