NeuVax study for HER2 3+

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naps
naps Member Posts: 61

Hello,

Does anyone have any experience with any of the NeuVax studies ?

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  • MinusTwo
    MinusTwo Member Posts: 16,634
    edited January 2017

    Naps: Apparently it's still in trials and will be 3 more years before results. This report is interesting since it appears to show that the proposed vaccine isn't effective if you have higher HER2 expression. Is anyone in the trials?

    https://www.thestreet.com/story/11507036/1/galenas...

  • SpecialK
    SpecialK Member Posts: 16,486
    edited January 2017

    I don't think there are any current Neuvax trials enrolling for anyone who is Her2 3+, only for concurrent Neuvax given concurrently with Herceptin for those who express at Her2 levels 1+ and 2+. This trial is for those who have not been previously treated with Herceptin. Were you wondering about enrollment or study results?

    Edited to add the link below - my initial search only yielded results for low Her2 expressors.

  • naps
    naps Member Posts: 61
    edited January 2017

    Thanks for your input.

    There is another one for over expressers (3+) of HER2, also given in conjunction with Herceptin.

    I know the "PRESENT" study was closed for futility last year, though earlier studies have looked promising.

    Just wondering about any results of interim analyses, longer term follow up of those earlier patients, etc.

  • SpecialK
    SpecialK Member Posts: 16,486
    edited January 2017

    This one?

    https://clinicaltrials.gov/ct2/show/NCT02297698?term=neuvax&rank=1

    Also, I participated in this Her2+ vaccine trial, but I am not sure if, or when, Phase III will happen. This was a two-armed trial, and patients were sorted into two different vaccine groups depending on their histological tissue type. One of the vaccines, the arm I was in, did very well, but the other, which also included some lower expressors did not have the desired results. So, I am not sure if this study will go forward - either with both vaccines, or with the vaccines treated separately. There was some additional legal complication involving documentation and drug rights with the study originator so I am not sure of the current status. This study was the type that patients could enroll in when their course of chemo and Herceptin was finished, but enrollment had to occur within six months from last Herceptin infusion.

    https://clinicaltrials.gov/show/NCT00524277

  • naps
    naps Member Posts: 61
    edited January 2017

    Interesting. Do you know which arm you were in? Looks like they were comparing 2 different vaccines+ gmcsf and also just the gmcsf immune stimulator alone. I wonder how that arm did.

  • SpecialK
    SpecialK Member Posts: 16,486
    edited January 2017

    I was in the GP2 arm, which is the vaccine that did better as far as preventing recurrence. Patients were sorted into the arms based on their histological tissue type. A2+ went to the GP2 arm, and A2- to the AE37 arm. This is the type of tissue typing as is done for organ transplant, and is an independent marker from anything to do with breast cancer. I believe that in Phases I/II of the GP2 arm the recurrence free rate for those receiving both the vaccine and GM-CSF was 94%, versus 85% for those receiving the GM-CSF alone, which was the placebo arm, according to this:

    http://www.ascopost.com/issues/april-10-2016/breast-cancer-vaccines-moving-forward-at-a-fast-clip/

    I believe there were more low Her2 expressors included in the AE37 arm, because that vaccine had been described as "promiscuous" meaning it had a broader potential benefit regardless of the level of Her2 expression, but I don't know if the lack of success for that arm receiving the vaccine plus GM-CSF can be correlated to level of Her2.

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