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Activity Number: 390
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304464
Title: Maximizing the Role of Survival Post-Progression in Predicting Probability of Technical Success for Oncology Confirmatory Trials
Author(s): Ke Zhang*+
Companies: Pfizer Inc.
Address: 10555 Science Center Drive, San Diego, CA, 92121, United States
Keywords: Progression-Free Survival ; Overall Survival ; Survival Post-Progression ; Oncology ; Bayesian ; Probability of Technical Success

Progression-free survival becomes a popular end point in cancer drug development majorly due to the fact that it requires a smaller sample size and shorter follow-up. With overall survival remaining the gold standard endpoint for demonstrating clinical benefit, it is important to investigate the relationship between PFS and OS when designing oncology confirmatory trials. Survival Post-Progression (SPP) is a parameter that directly measures the survival following disease progression and plays a critical role in answering the question of PTS (probability of technical success) in the oncology confirmatory trials with OS being the primary endpoint. In order to fully maximize the role of SPP, we propose a Bayesian simulation approach that combines the PFS and SPP information collected in Phase 2 studies to predict the OS benefit in a confirmatory clinical setting. The approach has been implemented in the real world examples to demonstrate how it helps the trial designers assess the Phase 2 results and increases the PTS in oncology confirmatory trials.

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