DESTINY-Breast03 Phase 3 Study Results
Overall Safety Summary
10
Daiichi-Sankyo
DESTINY-Breast04
Safety analysis seta
n (%)
Total patient-years of exposure, yearsb
T-DXd
(n = 371)
283.55
63.59
TEAEs
369 (99)
169 (98)
Grade ≥3
195 (53)
116 (67)
TPC
(n = 172)
• Median treatment duration
- T-DXd: 8.2 months (range, 0.2-33.3)
―
TPC: 3.5 months (range, 0.3-17.6)
• Most common TEAE associated with treatment
discontinuation
- T-DXd: 8.2%, ILD/pneumonitisc
-
- TPC: 2.3%, peripheral sensory neuropathy
Serious TEAES
TEAEs associated with dose discontinuations
TEAEs associated with dose interruptions
103 (28)
60 (16)
143 (39)
43 (25)
• Most common TEAE associated with dose reduction
14 (8)
-
T-DXd: 4.6%, nausea and fatigued
-
TPC: 14.0%, neutropeniad
72 (42)
• Total on-treatment deathse
TEAEs associated with dose reductions
TEAEs associated with deaths
84 (23)
14 (4)
66 (38)
-
T-DXd: 3.8%
5 (3)
- TPC: 4.7%
ASCO 2022 #LBA3 Plenary Session
ILD, interstitial lung disease; T-DXd, trastuzumab deruxtecan; TEAE, treatment-emergent adverse event; TPC, treatment of physician's choice.
aSafety analyses were performed in patients who received ≥1 dose of a study regimen. Patient-years of exposure are the treatment duration with year as unit. Grouped term. Fatigue includes the preferred terms fatigue, malaise, and asthenia; neutropenia
included the preferred terms of neutropenia and neutrophil count decreased. "On-treatment death was defined as any death that occurred from the date of the first dose to 47 days after the last dose of study drug irrespective of the cause; the TEAEs associated
with deaths represent a subset of on-treatment deaths reported by the investigators as adverse events.
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