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Latest Update of
Dendreon Vaccine Trial Shows Significant Benefit
The interim update at
30 months post completion of the Phase III Dendreon "Provenge" Vaccine
trial, D9901, shows a 30.7 month median survival time for the vaccine
treated patients compared to 22.3 months for the control patients. This
trial studied men with progressive metastatic hormone refractory
prostate cancer. The interim update data was based on the subset of
patients with Gleason sum < 7 cancer. In this Gleason < 7
subset at 30 months the survival rate for treated men is 53% v. control
14%. These positive clinical results in this subset are supported by
Dendreon's basic science data that showed that Provenge treated men with
a Gleason sum < 7 developed a T-cell mediated immune response
7-fold greater than men with Gleason sums > 8 (P = 0.0065). The
follow-up continues and a final report will be made in the future.
Although it is statistically inaccurate to compare different trials that
are not carefully matched, nonetheless, to put these interim results of
the vaccine trial into context, the best reported median survival data
for chemotherapy in metastatic hormone refractory PC was achieved in the
Taxotere/Calcitriol trial: 19.5 months, and most chemotherapy regimens
yield a median survival in the range of 10 - 15 months.
Dendreon's current
follow-up trial, D9902B, (reviewed in September PCa Commentary) is open
for enrollment and exclusively accepts men who have metastatic prostate
cancer that has progressed following hormone therapy and have a Gleason
sum < 7. One prior chemotherapy treatment is allowed if it was
completed 6 months prior to protocol entry. Study entry is available
through Dr. Corman, Virginia Mason, or Dr. Tia Higano, University of
Washington.
The reported interim
results from the D9901 trial in metastatic disease reflect encouragingly
on the prospects for benefit from vaccine treatment in the currently
open P11 "Provenge" vaccine trial, which focuses on men demonstrating a
PSA failure post prostatectomy before androgen
deprivation. The target enrollment of this trial is 160 men and it is
hoped that accrual will be completed by mid 2004. Entry into this study
is available through Drs. Corman and Higano, and, also, Dr. Jack West,
Swedish Cancer Institute.
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