DESTINY-Breast03 Phase 3 Study Results
DESTINY-Breast03: Safety Summary
Ο
DESTINY-Breast03
Daiichi-Sankyo
Median (range) treatment duration²:
•
⚫ T-DXd: 14.3 (0.7-29.8) months
•
⚫ T-DM1: 6.9 (0.7-25.1) months
⚫ Most common TEAE associated with treatment
discontinuation³:
T-DXd
T-DM1
n (%)¹
(n = 257)
(n = 261)
Any drug-related TEAE
252 (98.1)
226 (86.6)
•
Drug-related TEAE grade ≥3
116 (45.1)
104 (39.8)
Serious drug-related TEAE
28 (10.9)
16 (6.1)
Drug-related TEAE associated
with discontinuation
33 (12.8)
13 (5.0)
Drug-related TEAE associated
91 (35.4)
34 (13.0)
with dose interruption
•
Drug-related TEAE associated
55 (21.4)
33 (12.6)
with dose reduction
Drug-related TEAE associated
0
0
with an outcome of death
•
T-DXd: ILD/pneumonitisa (8.2%)
•
T-DM1: thrombocytopenia (2.7%)
Most common TEAEs associated with dose reduction³:
•
T-DXd: nausea (6.2%), neutropenia (3.5%)
T-DM1: thrombocytopenia (4.2%),
•
ALT and AST increased (2.7% each)
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ILD, interstitial lung disease; PTs, preferred terms; SMQ, standardized MedDRA query; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab
deruxtecan; TEAE, treatment-emergent adverse event.
Relationship to study drug was determined by the treating investigator. Interstitial lung disease includes events that were adjudicated as ILD and related to use of T-DXd or T-DM1 (includes cases of potential
ILD/pneumonitis, based on MedDRA v23.0 for the narrow ILD SMQ, selected terms from the broad ILD SMQ, and PTS of respiratory failure and acute respiratory failure). This category includes the PTs platelet count
decreased and thrombocytopenia. This category includes the PTs neutrophil count decreased and neutropenia.
1. Cortés J et al. N Engl J Med. 2022;386(supplement). 2. Cortés J et al. N Engl J Med. 2022;386:1143-1154. 3. Cortés J et al. Presented at: ESMO Virtual Congress 2021; September 16-21, 2021. Presentation 2525.
ESMO BC 2022 #1630 Oral
From New England Journal of Medicine, Cortés J et al, Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer, Vol. 386, Pages 1143-
1154(supplement). Copyright © 2022 Massachusetts Medical Society. Reprinted with permission [pending] from Massachusetts Medical Society.
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