FT says that another Provenge trial may still be needed


OK folks … please don’t shoot the messenger … I do not agree with the suggestions about the need for another trial in an article published today by the Financial Times. However, I would be a pretty poor reporter if I didn’t let you know this article is out there in a major international newspaper! I am not going to comment. Just read it for yourselves.

3 Responses

  1. Evening Mike,

    I think it’s only right that you posted the FT article as it’s still early days for Provenge — or do you think it could be fast tracked to the market?

    Hopefully we will get to know more details at this months AUA.

    Here is another viewpoint and yes it’s on the skeptical side but I think it’s worth taking a step back at this relatively early stage:

    Dendreon Still Faces Hurdles for Provenge Despite Positive Phase 3 Data

  2. Dear 5th String:

    I think everything is going to depend on just how good the Provenge data really is. We will get at least some idea of this on the 28th.

  3. I have a feel of both unease and deja vu all over again. These are the snips from the Financial Times piece that seem to be at the bottom of this:

    “The first Phase III studies for Provenge, named D9901 and D9902A, both failed to meet their primary endpoint and also failed to demonstrate statistical significance on other pre-specified endpoints. When the data from the two trials was pooled and analyzed retrospectively, Dendreon found that there was a difference in OS between the active and placebo arms.” Nothing like a good retrospective shuffling of data to prove a point that wasn’t proved before!

    “A second executive, who is familiar with Dendreon’s management, said it is quite unusual for a company to change the trial design in the middle of the game. ‘In my experience, the FDA scorns such attempts as manipulative since these are agreed upon prospectively,’ he said.” Hmmm. Change the trial design? Surely not!

    “[I]f Provenge shows a four-month survival benefit, it is still ‘not going to knock people’s socks off,’ he said.” Yes, I know about medians and that some Provenge patients are still alive a good deal longer than 4 months, but then 50% of the men didn’t make 4 months.

    “A Phase III clinical study named IMPACT showed that Provenge improved overall survival in patients suffering from advanced prostate cancer, pushing Dendreon’s shares up 136%, reports Pharmawire.” Now there’s the shiver down my spine again. Hope Martha Stewart hasn’t got any Dendreon shares — or at least doesn’t unload them on April 27.

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