DESTINY-Breast03 Phase 3 Study Results
Overall Safety Summary
n (%)
TEAEs
Related to T-DXd
Related to nivolumab
Grade 23 TEAES
Related to T-DXd
Related to nivolumab
Serious TEAES
Related to T-DXd
Related to nivolumab
TEAEs leading to any study drug discontinuation
Related to T-DXd
Related to nivolumab
TEAEs leading to T-DXd discontinuation
Cohort 1
HER2+
n = 29
Cohort 2
HER2-low
Overall
N = 48a
29 (100)
n = 16
16 (100)
48 (100)
26 (89.7)
13 (81.3)
42 (87.5)
24 (82.8)
13 (81.3)
40 (83.3)
15 (51.7)
7 (43.8)
24 (50.0)
10 (34.5)
1 (6.3)
11 (22.9)
8 (27.6)
3 (18.8)
11 (22.9)
12 (41.4)
4 (25.0)
1 (3.4)
0
18 (37.5)
1 (2.1)
2 (6.9)
1 (6.3)
3 (6.3)
14 (48.3)
3 (18.8)
18 (37.5)
9 (31.0)
2 (12.5)
12 (25.0)
7 (24.1)
3 (18.8)
10 (20.8)
12 (41.4)
1 (6.3)
13 (27.1)
Related to and leading to T-DXd discontinuation
9 (31.0)d
1 (6.3)
10 (20.8)
TEAEs leading to nivolumab discontinuationb
14 (48.3)
2 (12.5)
17 (35.4)
Related to and leading to nivolumab discontinuation
7 (24.1)9
2 (12.5)h
9 (18.8)
TEAEs leading to T-DXd dose reduction and related to T-DXd
TEAEs leading to any study drug interruption
3 (10.3)
0
4 (8.3)
14 (48.3)
8 (50.0)
23 (47.9)
8 (27.6)
3 (18.8)
12 (25.0)
Related to T-DXd
Related to nivolumab
5 (17.2)
7 (43.8)
13 (27.1)
2 (6.9)
2 (12.5)
5 (10.4)
TEAEs associated with death
Drug-related
1 (3.4)
0
1 (2.1)
Daiichi-Sankyo
HER2, human epidermal growth factor receptor 2; ILD, interstitial lung disease; T-DXd, trastuzumab deruxtecan; TEAE, treatment-emergent adverse event. aIncludes 3 patients treated at T-DXd 5.4 mg/kg RDE in
combination with nivolumab 360 mg during part 1. "Investigator assessed. Unrelated to T-DXd: 1 troponin T increase (grade 3); 1 blood bilirubin increase (grade 3); 1 femur fracture (grade 3). d1 amylase increase
(grade 3); 1 anemia (grade 3); 2 ILD (1 grade 1, 1 grade 2); 4 pneumonitis (1 grade 1, 2 grade 2, and 1 grade 5); 1 lichenoid keratosis (grade 3). e1 pneumonitis (grade 1). Unrelated to nivolumab: 1 blood bilirubin
increase (grade 3); 1 ILD (grade 1); 1 pneumonitis (grade 2); 1 amylase increased (grade 3); 1 femur fracture (grade 3); 1 anemia (grade 3); 1 aspartate aminotransferase increased (grade 2). 91 troponin T
increase (grade 3); 1 lymphocyte count decrease (grade 3); 1 vision blurred (grade 3); 2 pneumonitis (1 grade 1, 1 grade 5); 1 ILD (grade 2); 1 lichenoid keratosis (grade 3). h1 neutropenia (grade 3), 1 aspartate
aminotransferase increased (grade 3). 'Drug-related grade 5 ILD/pneumonitis. 13 disease progression; 1 malignant neoplasm progression; 1 ILD/pneumonitis.
ESMO BC 2022 #1620 Oral
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