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Activity Number: 140 - Design and Analysis of Cancer Immunotherapy Trials
Type: Invited
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #326872 Presentation
Title: Practical Considerations on the Challenges to the Design and Analysis of Immuno-Oncology Trials
Author(s): Yabing Mai and Yue Shentu*
Companies: AbbVie, Inc and Merck and Co Inc
Keywords: Immuno-Oncology; Group Sequential Design; Non-proportional Hazards; Trial Design

With the recent break-through of antibody therapies such as anti PD-1/PD-L1, a number of clinical trials have been conducted for Immuno-Oncology (IO) in cancer treatment and an even larger number of such trials are either ongoing or being actively planned. While more data are available to further confirm the efficacy of IO therapies, it also suggests these therapies share some typical properties such as the "later departure" of treatment effect and the varying biomarker associated enrichment, which has posed some unique challenges to the design and analysis of IO trials. In this presentation, we review a few typical examples of such challenges based on our experience in late-stage clinical development of PD-1 antibody. Practical considerations in the fields of group sequential design (GSD), multiplicity control, event-driven milestone projection and Non-proportional hazards (NPH) methods are proposed to address these challenges.

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

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