DESTINY-Breast03 Phase 3 Study Results
Time to First Onset of TEAES
T-DXd
T-DM1
•
Median time to event, days
n = 257
n = 261
TEAE associated with treatment
224
147
discontinuation
TEAE associated with first dose reduction
96
19
Selected TEAES
Anemia
Lymphopenia
Thrombocytopenia
Fatigue
Leukopenia
Neutropeniaa
Nausea
Vomiting
Alopecia
70.0
42.0
196.0
168.0
132.0
8.0
22.0
24.0
74.5
92.0
64.0
105.0
2.0
3.0
10.0
27.0
6.0
43.0
10
Daiichi-Sankyo
DESTINY-Breast03
.
TEAEs associated with first drug
discontinuation or first dose
reduction occurred later with T-DXd
treatment than with T-DM1
treatment
Median time to any TEAE
associated with first dose reduction
was longer in the T-DXd arm at 96
days compared with the T-DM1 arm
at 19 days
T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; TEAE, treatment-emergent adverse event.
Selected TEAEs (and preferred terms included): anemia (hemoglobin decreased, red blood cell count decreased, anemia, hematocrit decreased); lymphopenia (lymphocyte count decreased, lymphopenia); neutropenia (neutrophil count decreased, neutropenia);
thrombocytopenia (platelet count decreased, thrombocytopenia); leukopenia (white blood cell count decreased, leukopenia); fatigue (fatigue, asthenia, malaise).
a11.7% of patients in the T-DXd group and 2.3% of patients in the T-DM1 group were treated with G-CSF within 28 days after onset of neutropenia, including febrile neutropenia.
Safety update: Sept 7, 2021
ASCO 2022 #1000 Oral
29
20View entire presentation