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Activity Number: 644 - Statistical Methods for the Co-Development of Drug and Companion Diagnostic in Oncology
Type: Topic Contributed
Date/Time: Thursday, August 1, 2019 : 10:30 AM to 12:20 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #304765
Title: A Case Study in Bridging for Companion Diagnostic Development: Pembrolizumab and PD-L1 Selected 2nd Line NSCLC Patients
Author(s): Jared Lunceford* and Ellie Corigliano and Siddhartha Mathur and Ziwen Wei and Yue Shentu
Companies: Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
Keywords: companion diagnostic; bridging study; imputation

Early or late phase clinical trials that aim to enroll a biomarker selected patient population are often initiated using a clinical trial assay (CTA) which may differ in assay components compared to the final companion diagnostic assay (CDx), potentially necessitating further clinical analysis to bridge study conclusions to results based on the CDx. There may be substantial missing data due to the retrospective nature of CDx sample testing. We review key elements of a bridging study conducted for a randomized trial of pembrolizumab in second line metastatic non-small cell lung cancer. Emphasis is on methods aimed at constructing an imputation model to (1) facilitate confirmation of the robustness of clinical trial conclusions via the Bayesian posterior predictive distribution of the study’s intention-to-treat testing results and (2) conduct sensitivity analysis for estimands of the intention-to-diagnose population, while accurately capturing all sources of variability.

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

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