DESTINY-Breast03 Phase 3 Study Results
Drug-Related TEAEsa Reported in ≥20% of
Patients in Either Treatment Arm
T-DXd
n = 257
T-DM1
n = 261
n(%)
Any Grade
Grade ≥3
Any Grade
Grade ≥3
Nausea
Fatigue
189 (73.5)
17 (6.6)
72 (27.6)
1 (0.4)
118 (45.9)
16 (6.2)
76 (29.1)
2 (0.8)
Vomiting
114 (44.4)
4 (1.6)
15 (5.7)
1 (0.4)
Neutropenia
111 (43.2)
51 (19.8)
30 (11.5)
8 (3.1)
Alopecia
97 (37.7)
1 (0.4)
7 (2.7)
0
Anemia
82 (31.9)
16 (6.2)
37 (14.2)
11 (4.2)
Leukopenia
79 (30.7)
17 (6.6)
21 (8.0)
2 (0.8)
Decreased appetite
68 (26.5)
3 (1.2)
34 (13.0)
0
Thrombocytopenia
65 (25.3)
19 (7.4)
137 (52.5)
65 (24.9)
Diarrhea
61 (23.7)
1 (0.4)
11 (4.2)
2 (0.8)
Constipation
60 (23.3)
0
25 (9.6)
0
•
Daiichi-Sankyo
DESTINY-Breast03
Most of the selected drug-related
TEAEs in either treatment arm were
hematologic or gastrointestinal
T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; TEAE, treatment-emergent adverse events.
Selected TEAEs (and preferred terms included): anemia (hemoglobin decreased, red blood cell count decreased, anemia, hematocrit decreased); neutropenia (neutrophil count decreased, neutropenia); thrombocytopenia (platelet count decreased,
thrombocytopenia); fatigue (fatigue, asthenia, malaise).
aBased on nonclinical data, clinical data, epidemiology data, and reported data from drugs in a similar class (anti-HER2 therapies), selected TEAEs for T-DXd were reviewed for additional characterization.
Safety update: Sept 7, 2021
ASCO 2022 #1000 Oral
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