DESTINY-Breast03 Phase 3 Study Results
Patient Disposition
T-DXd treatment status, n (%)
Ongoing
7 (21.9)
1 (6.3)
Discontinued
25 (78.1)
15 (93.8)
Primary reason for discontinuing T-DXd, n (%)
Progressive disease
9 (28.1)
11 (68.8)
Clinical progression
3 (9.4)
2 (12.5)
Adverse event
10 (31.3)b
Patient withdrawal
1 (3.1)
Cohort 1
HER2+
n =
= 32a
Cohort 2
HER2-low
n = 16
Overall
N = 48
8 (16.7)
40 (83.3)
20 (41.7)
5 (10.4)
11 (22.9)
2 (4.2)
1 (6.3)c
1 (6.3)
Physician decision
1 (3.1)
0
1 (2.1)
Otherd
1 (3.1)
0
1 (2.1)
Nivolumab treatment status, n (%)
Ongoing
6 (18.8)
0
6 (12.5)
Discontinued
26 (81.3)
16 (100)
42 (87.5)
Primary reason for discontinuing nivolumab, n (%)
Progressive disease
8 (25.0)
11 (68.8)
19 (39.6)
Clinical progression
2 (6.3)
2 (12.5)
4 (8.3)
Adverse event
13 (40.6)e
2 (12.5)
15 (31.3)
Patient withdrawal
1 (3.1)
Physician decision
1 (6.3)
0
2 (4.2)
Duration of follow-up, median (range), months
Daiichi-Sankyo
2 (6.3)
18.7 (1.7-26.9)
12.7 (1.7-21.4)
2 (4.2)
18.2 (1.7-26.9)
HER2, human epidermal growth factor receptor 2; ILD, interstitial lung disease; RDE, recommended dose for expansion; T-DXd, trastuzumab deruxtecan.
aIncludes 3 patients treated at T-DXd 5.4 mg/kg RDE in combination with nivolumab 360 mg during part 1. b1 troponin T increase (grade 3); 2 ILD (1 grade 1 and 1 grade 2); 4 pneumonitis (1 grade 1, 2 grade 2,
and 1 grade 5); 1 amylase increase (grade 3); 1 femur fracture (grade 3); and 1 anemia (grade 3). c1 pneumonitis (grade 1). Patient decision. e1 anemia (grade 3); 1 aspartate aminotransferase increase (grade 2);
1 vision blurred (grade 3); 1 troponin T increase (grade 3); 2 ILD (1 grade 1 and 1 grade 2); 1 femur fracture (grade 3); 1 lymphocyte count decreased (grade 3); 4 pneumonitis (1 grade 1, 2 grade 2, and 1 grade
5); 1 amylase increase (grade 3). f1 neutropenia (grade 3); 1 aspartate aminotransferase increase (grade 3).
ESMO BC 2022 #1620 Oral
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