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Final
Results Of Dendreon Vaccine Trial D9901 In 127 Men With Metastatic,
Asymptomatic AIPC.
(July 2005)
At a median F/U of 36 months 82 men receiving the PAP/GM-CSF
vaccine (“Provenge”) as compared to 45 men on a placebo experienced a
median survival of 25.9 months vs. 22.0 months (P=0.020). At 36 months
from the start of the study 33% of the vaccine patients were alive vs. 11%
for the men in the placebo arm (P=.003).
In the evaluation of time to objective disease progression
it was noted that during the first 3 months of the study a large number of
men on both arms progressed. The ASCO presenter, Dr. Eric Small,
postulated that immunotherapy requires sufficient time to “kick in”, but
noted that at 8 weeks a T-Cell proliferation test evaluating immunologic
response showed an 8 fold superiority in the vaccine treated group. Dr.
Small cautioned against comparing the median survival figure in the D9901
trial with the two month prolongation of median survival achieved in the
recently reported Docetaxel/Emcyt vs. Mitoxanthrone/Prednisone trial since
the men in these chemotherapy study arms had more advanced disease. His
suggested strategy for vaccine usage in the AIPC setting (should the
vaccine be approved for general use) would be to initially employ the
vaccine while reserving chemotherapy for vaccine failures.
A pilot study of 22 men with AIPC combining Provenge with
Avastin has been reported and showed a prolongation of PSA DT from a
pretreatment value of 6.7 months to 12.7 months. Trials combining Provenge
with chemotherapy are planned.
The current Dendreon trial D9902B for
men, post prostatectomy, with AIPC and Gleason scores < 7 is
accessible at the Virginia Mason Medical Center and the Seattle Caner Care
Alliance. Details at Dendreon.com.
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