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November 6, 2009


 
Biologics License Application 125197 Sipuleucel-T (APC8015)

Agenda for clinical/stats initial T’con with BLA applicant Dendreon 11/06/09

Administrative, introduction of review team

Lori Tull – RPM 
Peter Bross – Clinical Team Leader
Bindu George – Primary Efficacy 
Chaohong Fan – Primary Safety 
Boguang Zhen – Primary Stats

Information request to sponsor: (we don’t expect to have this completed 
overnight however if Dendreon needs clarification regarding these requests 
please feel free to ask at the t’con tomorrow.  We can schedule a follow-up 
t’con to discuss the responses).
  Please provide a data listing of Halabi scores (expected survivals) at the 
  time of progression for those subjects who were documented to progress. For 
  subjects who received APC8015F please also provide scores at the time of 
  progression following infusion of the frozen product. If the data have been 
  submitted, please provide the variable name and dataset. 
  Please conduct exploratory sensitivity analyses comparing overall Kaplan Meyer 
  survivals between the two treatment arms: subjects who received subsequent 
  Docetaxel treatment, and subjects who did not receive subsequent Docetaxel 
  treatment (four subgroups).
  Please repeat the above analyses for subjects on both arms who received 
  salvage Docetaxel treatment at or reasonably close to the approved regimen of 
  75/M2 Q3 Wks, and subjects who did not receive salvage Docetaxel treatment at 
  or reasonably close to the approved regimen of 75/M2 Q3 Wks (four subgroups). 
  Also please provide an analysis of median Halabi scores at time of progression 
  for the subgroups described above.
  Please provide a data listing (SAS file) of those patients who were documented 
  to have received salvage Docetaxel treatment at or reasonably close to the 
  approved regimen of 75/M2 Q3 Wks.
  Please provide an analysis of the T cell responses (IFN-γ and Proliferation) 
  noting any correlations between the responses and survival data.  
  Please provide any preliminary data that is available regarding T cell 
  responses noted in P07-1 trial.
 

   