This morning, Dendreon released the highly-anticipated results from a Phase III trial of Provenge, the first therapy designed to trigger an immune response to combat prostate cancer. The Impact trial, as it was called, examined the overall survival of 500 cancer patients and was to stop once 304 of them had died. According to the release, the Phase III trial met the primary endpoint of improving overall survival compared to a placebo control, and the drug's safety profile appeared to be consistent with prior trials. But Dendreon said it can't share more details until the American Urological Association's Annual Meeting conference due to embargo rules.
Dendreon held a conference call this morning to discuss the Impact results. Amid congratulations from callers (and obvious relief from company executives), Dendreon discussed a few details regarding the trial. "Results are unambiguous. It was a clear hit on overall survival," said CEO Mitchell Gold. He added that Provenge may be leveraged to treat other cancer types, and that Dendreon is evaluating options to plan the drug's continued development. The cost of the drug has not been determined yet, but they expect it to be priced similar to other biologics in the space.
Dendreon says it now intends to file an amendment to its existing BLA in the fourth quarter of this year. It's looking for a partner in Europe to market the drug.
In 2007, an FDA panel endorsed the injection, but the FDA later rejected the prostate cancer therapy, saying that Dendreon needed to present more data. Provenge could rake in sales of $1 billion annually if approved. The company's shares, which had been gyrating prior to this morning's announcement, soared on the positive trial results.
- see the release
- here's the WSJ article for background