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Activity Number: 313 - Data Analytics and Visualization: Advances and Challenges
Type: Topic Contributed
Date/Time: Wednesday, August 5, 2020 : 10:00 AM to 11:50 AM
Sponsor: Section on Statistical Graphics
Abstract #312935
Title: Graphical Exploration of the Association Between Biomarkers and Efficacy Parameters in Oncology Trials
Author(s): Arteid Memaj* and David Paulucci and David Gold
Companies: Bristol-Myers Squibb and Bristol-Myers Squibb and Bristol-Myers Squibb
Keywords: Oncology; Immunotherapy; Biomarkers; Threshold Selection; Efficacy
Abstract:

The advent of immunotherapy (IOT) has led to improved oncologic outcomes for many indications. However, only a fraction of patients treated with IOT will actually respond. To identify subjects that are most likely to respond to IOT, significant efforts have been put forth to identify biomarkers that are prognostic or predictive of response. We present a graphical approach that evaluates the association between a continuous biomarker and a binary or time to event outcome. This graphical approach also facilitates identification of the optimal biomarker threshold to distinguish response within and between treatment arms. With this approach, the continuous biomarker’s values or percentiles are plotted against the binomial outcome rate, or time to event outcome landmark survival probability with its corresponding 95% confidence intervals. We present an application of this approach using simulated clinical trial datasets which exhibit proportional and non-proportional hazards which are common in IOT trials.


Authors who are presenting talks have a * after their name.

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