DESTINY-Breast03 Phase 3 Study Results
DESTINY-Breast04: Statistical Analysis and
Hierarchical Testing
Hierarchical testing
PFS in HR+
PFS in all patients
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Daiichi-Sankyo
DESTINY-Breast04
Primary analysis for PFS by BICR (planned after at least 318 events)
At data cutoff (January 11, 2022), there were 321 and 370 BICR-
assessed PFS events in the HR+ cohort and in all patients,
respectively
At data cutoff, 61 patients remained on treatment (58 on T-DXd and
3 on TPC), and median follow-up was 18.4 months
OS analysis
OS in HR+
OS in all patients
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199 events in the HR+ cohort and 239 events in all patients
Stopping boundary for first interim OS analysis:
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Efficacy boundary for superiority: P < 0.0075
BICR, blinded independent central review; HR, hormone receptor; OS, overall survival; PFS, progression-free survival; T-DXd, trastuzumab deruxtecan; TPC, treatment of physician's choice.
ASCO 2022 #LBA3 Plenary Session
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