Anyone see the phase3 for puma (neratinib)?

Options
Tinkerbells
Tinkerbells Member Posts: 211
edited August 2015 in HER2+ (Positive) Breast Cancer

from what I understand they are saying a 33% improvement in DFS (2 or 3 years?) over herceptin. Have to read full details but think study was for early stage. Not sure if hormone receptor +/- or node involvement. Study does not compare puma to perjeta or herceptin/perjeta combo. 

Apparently diarrhea is a concern. I can't wait to read study once it is published- could it lead to there being a triple blockade for her 2? I'm just grateful they are still looking Into her2 targeted therapies.

· Share on FacebookShare on Twitter

Comments

  • positivenegative
    positivenegative Member Posts: 106
    edited July 2014


    right on mscaruso.  ThumbsUp I read it.  I didn't like the study trial sample size was very small was my only concern.

    Puma Biotech's neratinib should be on the market in Jan 2015 now that it passed FDA approval according to the info yesterday.  It is for MBC HER2+ as well in addition to Herceptin and Perjeta regiment.  Every drug seems to have diarreah as a side effect LOL.  I'm asking my MO about this new drug.  Us HER2+s need everything we can get to put the brakes on aggressiveness of HER2+ BC.

    Question to the Mods--any articles on this new drug yet in BCO library?

    · Share on FacebookShare on Twitter
  • Tinkerbells
    Tinkerbells Member Posts: 211
    edited July 2014

    if it is approved- maybe we can get it after the year of herceptin/perjeta. There is talk of a year of neratinib post standard treatment. Let's see what happens. I hope all the good news is really true for us her2 ladies 

    · Share on FacebookShare on Twitter
  • ben50
    ben50 Member Posts: 46
    edited July 2014

    It's not over herceptin, it's after herceptin in the "extended adjuvant" setting. This is huge, huge news. So you would do your full year of herceptin then another year of this new neratinib. And 33% reduction in recurrence?? And it's completed its phase 3 trial?! I haven't been this excited about cancer news in a long time. It's usually: "we tested a new vaccine on a rat and it slowed cancer, now we have no funding to begin clinical testing. try us again in 15 years." No this is something that could affect a lot of us. Especially exciting because my wife will be done with her herceptin/perjeta in December so the stars seem to be aligning! How exciting!

    · Share on FacebookShare on Twitter
  • Tinkerbells
    Tinkerbells Member Posts: 211
    edited July 2014

    You're right - talked it over with my MO and she is not impressed - because there is nothing published on changes in OS.  She says DFS alone is not good enough given the significant problems with diarhhea that Puma has so far.  (she says there were deaths from colitis in the MBC setting).  I would be very surprised if there is no trickle down into OS from that DFS after all is published, but we will have to wait and see.  I am willing to go search for it if it is approved.  I think her@ is agressive and unpredictable and want to do everything I can. I'm hoping it will be presented at the San Antonio conference in December.

    · Share on FacebookShare on Twitter
  • soriya123
    soriya123 Member Posts: 662
    edited July 2014

    wow i just fnished my herceptin this month.  i wonder once FDA approved in jan i able to get it too.  

    · Share on FacebookShare on Twitter
  • Girlstrong
    Girlstrong Member Posts: 438
    edited July 2014

    this is great news for us with HER2; I know I'll be investigating and talking to my MO about it. More to come before the end of the year... Thanks for sharing. 

    · Share on FacebookShare on Twitter
  • BlueFox
    BlueFox Member Posts: 99
    edited August 2014

    More information

    http://www.pharmatimes.com/article/14-07-23/Puma_l...

    http://www.onclive.com/web-exclusives/Extended-Adj...

    · Share on FacebookShare on Twitter
  • cbm
    cbm Member Posts: 475
    edited August 2014

    Hi; I was among the last enrolled in the neratinib clinical trial in 2011.  I am fairly sure I got the drug and not the placebo, as I still have the sudden onset neuropathy that showed up in a rush of foot tingling and numbness on Day 7.  Not everybody got the big D (diarrhea); I only got it when adding Keflex for fairly frequent skin lesions/infections that I assume was also a side effect.  If I remember correctly, the added value of the neratinib is that it crosses the blood-brain barrier, which Herceptin does not.  

    There is a sizable thread on this board from the trial if anyone is interested in the scope of the side effects.  I think (again if I remember correctly) that the diarrhea was how most participants identified that they were in the drug arm of the trial.  The range on the severity was enormous, with most folks who were able to stay in being successfully controlled with anti-diarrhea meds.  

    This is very exciting news, indeed.

    Warmly,

    Cathy

    · Share on FacebookShare on Twitter
  • letranger
    letranger Member Posts: 234
    edited July 2015

    is anyone on the neratinib and xeloda trial? I'm am considering and and urgentlyneed some guidance. Thank you so much!

    · Share on FacebookShare on Twitter
  • JohnSmith
    JohnSmith Member Posts: 651
    edited August 2015

    I'm curious about these Neratinib trials as well.

    Is the toxicity (Grade 3 diarrhea) as bad as I'm reading?

    · Share on FacebookShare on Twitter
  • letranger
    letranger Member Posts: 234
    edited August 2015

    I'm on the neratinib + xeloda combo trial. I am waiting for side effects! I started 6days ago and I am doing ok so far. But maybe the side effects will show up later? I can't find anyone else who is currently on this trial.

    · Share on FacebookShare on Twitter

Categories