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Activity Number:
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29
- Statistical Issues Specific to Therapeutic Areas, Power and Sample Size Calculations, and Trial Monitoring
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Type:
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Contributed
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Date/Time:
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Sunday, August 8, 2021 : 1:30 PM to 3:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #318241
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Title:
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Novel Measures of Treatment Efficacy Under Delayed Treatment Effects
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Author(s):
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Kijoeng Nam* and Nicholas Henderson and Dai Feng
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Companies:
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Merck & Co., inc. and University of Michigan and AbbVie Inc.
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Keywords:
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non-proportional hazards;
immuno-oncology;
constrained estimation
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Abstract:
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Many immuno-oncology (IO) therapies frequently exhibit a clear delay in treatment effect with the survival curves or hazard functions sometimes crossing early in the study. We introduce several interpretable measures of treatment effect that can be useful when such crossings occur. Efficacy measures described include crossing-conditional survival probabilities, proportion surviving up to crossing, crossing-conditional estimates of restricted residual mean life, and pre/post-crossing average hazard ratios. We demonstrate the use and interpretation of these measures with a large simulation study and an analysis of a recent IO combination-therapy trial.
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Authors who are presenting talks have a * after their name.
