What’s new with Provenge?

The “New” Prostate Cancer InfoLink has seen a couple of statements from members of the financial community in the last few days that could mislead the unwary into believing that Dendreon’s investigational immunotherapeutic agent, sipuleucel-T (Provenge), has already demonstrated a statistically significant survival benefit in its most recent Phase III clinical trial (the IMPACT trial) — see for example an article in Forbes today.

We wish to be very clear that this is not the case (at least as yet). The results of the IMPACT study are not expected before April at the earliest, and sipuleucel-T will need to demonstrate a better than 20 percent improvement in survival of the patients in the active treatment arm compared to placebo for anyone to feel comfortable about the chances for an FDA approval of the drug.

At a planned interim analysis of the data last year, a 20 percent survival benefit compared to placebo was exactly what sipuleucel-T appeared to be demonstrating at that time. A recent conversation with Dendreon personnel suggested to me that employees are optimistic but nervous about whether Provenge will be able to show the required survival benefit.

One Response

  1. By chance I was at a meeting arranged by one of the Australian Prostate groups on Saturday. The guest speaker was Dr Mark Moyad and he expressed the view that in his opinion Provenge would probably get over the hurdle.

    I have to say, I thought it was a bit irresponsible, although to be fair, he also said it might not … but he was pretty sure it would!!

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