Page 10 - Flipbook

10
MAGNITUDE: Statistical Analysis Plan

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Prospective a priori approach to examining outcomes in HRR BM+ and HRR BM cohorts

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HRR BM Cohort
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• Pre-specified futility analysis planned in the HRR BM population after enrolling ~200 of a planned 600 patients
and ~125 composite progression events (first of either radiographic or PSA progression)

• IDMC was to recommend whether the HRR BM study cohort continue or discontinue enrollment to support patient
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safety and prevent overtreatment

HRR BM+ Cohort

• Primary and secondary endpoints were tested using a pre-specified statistical hypothesis testing strategy to control the

family-wise Type I error rate at a 2-sided level of 0.05
• Primary endpoint: BRCA1/2 subgroup was specifically powered and tested first and if statistical significance was

reached all HRR BM+ patients were to be tested

• A total of 400 patients were planned to be enrolled into the HRR BM+ cohort; 50% were to be BRCA1/2 positive

BM, biomarker; HR, hazard ratio; HRR, homologous recombination repair; IDMC, independent data monitoring committee; PSA, prostate-specific antigen.

PRESENTED BY: Kim N. Chi, MD