I have never posted here, but the idiocy of people on this board is astounding. First, to be clear, I do not work for Dendreon, so for any of the replies that follow trying to imply that I do, suck it. Nor am I an investor. I am, however, an experienced industry person.
Now to Zytiga, the failure to show a statistically significant benefit in overall survival is critical. This is the endpoint that is required for approval in metastatic prostate cancer (PCa). Anyone ever hear of Sutent, Avastin, Satraplatin or Atrasentan? All these drugs showed improvements in PFS or TTP, but are not approved for use in PCa. Without the approval, reimbursement for Zytiga is not a given, although one could make a case that insurance carriers may be willing to pay $5K/month rather than $90K upfront. That being said, since Zytiga would be used earlier in this scenario, it is possible that the time on therapy might increase, thus narrowing the cost differential, albeit with no improvement in overall survival.
To be fair, it is possible that this "trend in OS" could change to significant with greater follow-up, as the survival advantage in the post-docetaxel setting increased with additional follow-up. However, unblinding the patients, while ethical, may create a confounding effect, as placebo patients cross-over and hopefully experience the proven benefits of Zytiga later in their disease spectrum.
In response to this brilliant quote:
"Memorial Sloan Kettering's Susan Slovin said she thought Provenge would be used, just not as enthusiastically as it was at first. She summed it up for Reuters this way: "[Zytiga] is taking the market by storm; there is a much faster effect with it," Slovin said. "Pain is markedly improved, along with the ability to eat, drink, go out and do what they normally would do. The patient says, 'Look, I really don't see the need to sit here and send my (blood) to wherever...I want to take a pill and go to Florida.' "
Provenge is meant for use in patients with no cancer-related pain or cancer-related pain that does not require narcotics, thus it does not surprise me that Zytiga may be more effective in reducing pain. It does surprise me that someone from MSK would make a statement like that, however. I would also argue that while having 3 procedures to remove WBC's sounds mildly annoying, treatment lasts roughly only one month. Although I am not a doctor, the literature is replete with data about patient compliance issues associated with oral cancer medications. Despite the fact that Zytiga is given once daily, it does require concomitant use of prednisone twice daily. That is a lot of pills to remember to take, especially over months of time. Thus, the actual benefits from the use of Zytiga are dependent on patient compliance. This is not an issue with Provenge;3 infusions, and you are done. Go to Florida now...
Now, the flipside...Urologists would prefer to use something that does not need to be infused, and they have "control" of the patients. An oral option if available, even if less effective, would be more likely to be used by this surgical audience.
As far as Alpharadin, dumb ass, it is meant for use in patients with symptomatic metastases and most of the patients in its pivotal trial had received prior docetaxel. Not sure how that fits the profile of use before Provenge....
As far as the COGs and appearance of impropriety at the C-Level, no way to deny those concerns. Not sure how appealing Dendreon/Provenge will be as a takeover for both of those reasons. I guess time will tell.
