The identification of Prognostic/Predictive biomarkers using optimal cutpoints for predicting response to therapy
View Presentation *Nusrat Rabbee, Genentech, Inc. Keywords: predictive marker, cutpoint determination, diagnostics The identification of prognostic or predictive markers are one of the major tasks in clinical cancer research. In a recent, Phase II clinical trial for Pertuzumab™ (Omnitarg, Genentech, Inc. South San Francisco, CA), we used a hypothesis-driven candidate gene approach to develop clinically feasible diagnostic assays for markers known to be related to the target pathway of the drug. We conducted exploratory analyses of the data to identify cutoffs for the diagnostic markers by correlating them to progression free survival (PFS). We used the minimum p-value method to dichotomize the continuous marker values. However, appropriate corrections need to be applied to correct for bias in p-values and the log-hazard ratios from multiple testing. We discuss various methods and challenges arising in the context of co-development of drug-diagnostic in our clinical trial settings.
|
Key Dates
-
April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC