1. While I agree with the general conclusion of your comments that survival data beyond 36 months would not be prespecified data per the 9901 or 9902a Statistical Analysis Plans, they might play an important supporting role.
2. DNDN's 9902b and CEGE's Vital 1 and Vital 2 are all Phase 3 trials in AIPC and are all based on concluding the trial when a certain prespecified number of deaths occurs, allowing calculation of median survival between the ITT and control groups. There will be no actual trial data collected for 36 month survival. For its Phase 2 median survival estimate, CEGE plugged patient data in the Halabi nomogram, and then compared its patient median survival data with that projected by the Halabi nomogram.(The "Halabi model" for HRPC which derives a set of nomograms and 4 survival curves based on risk quartiles for death at the time of randomization: http://www.jco.org/cgi/content/full/21/7/1232?ck=nck)
3. The Halabi nomogram, in fact, represents a potential Bayesian analytical tool to compare not only ITT patients, but also crossover Provenge patients, with historical AIPC controls. Eric Small, the lead clinical investigator for 9901 and for CEGE's Vital 1 trial coauthored the nomogram. Data collected and survival curves extend well beyond 36 months, so long-term Provenge treated patient survival data beyond 36 months might be valuable in computing statistical comparisons between actual and projected historical data. While the FDA is a long way from allowing Bayesian analysis (except for medical devices) as opposed to randomized, blinded, placebo control;ed trials as accepted data analysis to allow approval of a BLA/NDA, I would find it hard to argue against inclusion of such analysis as a valuable comparative tool. Another nomogram was reported at: PreTreatment Nomogram for Disease-Specific Survival of Patients with Chemotherapy-Naive Androgen Independent Prostate Cancer.Eur Urol. 2006 Jan 6; [Epub ahead of print] Pre-Treatment Nomogram for Disease-Specific Survival of Patients with Chemotherapy-Naive Androgen Independent Prostate Cancer.Eur Urol. 2006 Jan 6; http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_...
News 
Market Data 
Discover 
AI
