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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 #318536
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Title:
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On Characterizing Survival Curve of CAR-T Cell Therapy
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Author(s):
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xiaoling wu*
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Companies:
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Legend Biotech
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Keywords:
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Non-proportional hazard;
RMST;
CAR-T
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Abstract:
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Median and hazard ratios are often reported to characterize and compare long term effect such as PFS or OS of CAR-T trials. On the other hand, median may not be estimable due to insufficient follow up time. In addition, the proportional hazard assumption essential to establish Cox model and its hazard ratio might not hold true either. Because patients may progress and drop out during the month also time from randomization to infusion. Recently, restricted mean survival time (RMST) is discussed as one of the alternative summary measures for the time-to-event outcome. This work summarizes the necessary information to conduct statistical analysis using the RMST, including how to estimate and model RMST in single arm trial. And discussed how to compare RMST in the setting of randomized trial. Audience may walk away with a better understanding of various statistics characterizing time to event outcome of CAR-T trials.
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Authors who are presenting talks have a * after their name.
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