


Further Discussion of Study D9902B - Provenge, October 30, 2009


 
(System Info - 126674 TULL LORI 04/22/2010 11:33:42 TULL)
TELECON SUMMARY

Date:   Oct 30, 2009
Time:  1:00 PM

FDA Participants: Drs. Bross, Gupta, Hsu, Zhen
External Consultant: Dr. Ralph D’Agostino, Boston University, Boston, MA

Subject:  Further discussion of Study D9902B

Dr. D’Agostino acknowledged that he had received the sponsor’s clinical study 
report and the FDA exploratory sensitivity analyses and had reviewed them.
We described to him the results after stratifying the time to docetexal as a 
salvage therapy, as he had suggested in the previous teleconference. These 
results still showed a difference between treatment arms consistent with a 
treatment effect. He was not surprised with these results.

He was impressed with the graph with four survival plots comparing patients 
subsequently treated with docetaxel with patients that did not receive 
subsequent docetaxel. He thought this analysis was helpful and did not suggest 
confounding by salvage treatment. He suggested providing the sample sizes of 
each arm on the graph. 

He further stated that additional analyses would be unlikely to provide any 
useful information.  When asked to suggest additional analyses, he suggested 
considering a competing risk analysis using time to docetexal therapy as an 
event. He said that this would likely bring the hazard rate closer to one, and 
he was not sure that this would provide a meaningful analysis.
 

   