Kyprolis fails in first line setting

Discussion in 'Amgen' started by anonymous, Sep 27, 2016 at 10:48 AM.

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  1. anonymous

    anonymous Guest

    September 27, 2016
    Sept 27 (Reuters) - Amgen Inc said on Tuesday its cancer drug Kyprolis failed to meet the main goal of a late-stage study against Takeda Pharmaceutical Co Ltd's Velcade for treating newly diagnosed multiple myeloma.

    The Phase III study evaluated Kyprolis in combination with chemotherapy drug, melphalan and immunosuppressant prednisone.

    However a sub population of pedophiles in Lithuania showers superiority. N=5 and p-value of 1.
     

  2. anonymous

    anonymous Guest

    The trial failed due to design. The trails design was due to Onyx. Amgen should have taken control sooner.
     
  3. anonymous

    anonymous Guest

    Furthermore, we don’t think Kyprolis was ever set to get much use there given new CD38 antibodies like Johnson & Johnson (JNJ) Darzalex and other new drugs that docs tell us are more likely to be used in combo with Celgene (CELG) drugs like Revlimid. In fact one should expect to see some pressures even in 2/3 line because Darzalex launch is going well and it’s currently approved in later lines for salvage patients….though this is still a smaller line item for Amgen on a quarterly basis.

    Darzelex will continue to eat kyprolis!
     
  4. anonymous

    anonymous Guest

    Generic Velcade in 2019!!! Just as good and wayyyy cheaper.

    For the Phase III trial, Amgen enrolled 995 patients and randomized them to receive one of two regimens, which paired either Kyprolis or Velcade with melphalan and prednisone. After 54 weeks, there was next to nothing between the two cohorts in terms of progression-free survival, resulting in the trial missing its primary endpoint. Median PFS in the Kyprolis arm was 22.3 months, compared to 22.1 months for the Velcade cohort.
     
  5. anonymous

    anonymous Guest

    Amgen, today you are my bitch!! Thanks for the $10.5 billion suckas!!

    Signed, Tony Coles, Onyx CEO
     
  6. anonymous

    anonymous Guest

    Another Amgen BD Failure!

    Add to parasabiv, blincyto, corlanor, vectibix
     
  7. anonymous

    anonymous Guest

    Kyprolis combined with melphalan and prednisone extended PFS to 22.3 months vs. Velcade-melphalan-prednisone's 22.1-month PFS, Amgen said in a news release. The Kyprolis regimen also proved more fatal — 6.5% of patients died vs. 4.3% of patients on the Velcade regimen.


    No benefit and more toxic! You sure do pick winners Amgen!!!
     
  8. anonymous

    anonymous Guest

    Can't stand this company anymore. Interviewing like crazy to get out. Manager is a micromanager. Sucks
     
  9. anonymous

    anonymous Guest


    SORRY PCP SUPPORTIVE CARE HACK!!
     
  10. anonymous

    anonymous Guest


    Yep. Typically Amgen loser rep.
     
  11. anonymous

    anonymous Guest

    Spoke to a KOL and they said this study "sucked". Us doctors don't use the two drugs used with Kyprolis and velcade. Doh dumb trial design
     
  12. anonymous

    anonymous Guest


    ONYX designed the trial so they are to blame!
     
  13. anonymous

    anonymous Guest

    Blame it on the trial? Blame it on this snake oil death punch called Kyprolis!! If the outcome was good, it would have been the best trial ever!! Bottom line, Kyprolis is dead and Mr. Bradway got worked sideways by Mr. Coles.

    Score: Onyx 1 - Amgen - 0.
     
  14. anonymous

    anonymous Guest

    Even if the two drugs used are outdated, both Kyprolis and Velcade were equally screwed. The Kyprolis arm should have shown better data if it was the better drug. It didn't. This is why we do H2H trials and this shows that Kyprolis is no better.
     
  15. anonymous

    anonymous Guest

    There goes $10 BILLION in share holder value.
     
  16. anonymous

    anonymous Guest

    There may have been better PFS and toxicity with better combination such as Darzelex or Revlimid but you would see those benefits in both arms. Here the aim of the trial was to show that Kyprolis H2H would be better than Velcade in first line patients. The results show that it isn't better efficacy wise and it's even a little more toxic. The label expansion for Kyprolis is likely to stop in the 2nd line. Even with approval in first line, why use Kyprolis when in 8 more months Velcade will be generic. It's very troubling and Darzelex continues to take share. Ninlaro will slowly creep share away since oral formulation patients don't worry about neuropathy when driving to get treatment. Kyprolis is good drug but not worth the $10B to get it. This should have been a $5B acquisition at it's highest valuation with $3.5-$4B being fair.
     
  17. anonymous

    anonymous Guest

    Agree with most of,this but it will still get first line WITH Dara in the future. That's,the holy grail
     
  18. anonymous

    anonymous Guest

    If this is triplet therapy then:

    1. Dara + Revlimid + PI

    The question is whether a payer will pay for Kyprolis as the PI when Velcade is generic. Does the benefit of Kyprolis in this combination significantly greater than that of Velcade? Dara + Revlimid itself is $250K+ so adding kyprolis and making this a near $400k is going to a key question. Most studies with Dara and Revlimid by Celgene and Takada use velcade. If Amgen wants to show superiority, then Amgen will likely have to foot the bill. This will take time to set up studies, will be expensive, and the benefit if it does exist may not justify the price.

    If this is doublet:

    Will the combo be Dara + Revlimid or Dara + PI?

    Will that PI be Kyprolis, Generic Velcade or Ninlaro (tolerability). Keep in mind a doublet is because a patient is a fit for triplet therapy likely due to health state. If that's the case, then Ninlaro maybe a better PI choice.

    Kyprolis will get first line use, I just don't see at this moment how it will be substantial.
     
  19. anonymous

    anonymous Guest


    Amgen will need to pay for the trial. Payers will not allow 1st line access to kyprolis without H2H data over generic velcade. If the data is good, you get FDA approval. Depending on the magnitude of benefit and how that compares to velcade cost wise will determine the access.
     
  20. anonymous

    anonymous Guest

    These trials are already going on. Did you listen to the Amgen call?