DESTINY-Breast03 Phase 3 Study Results
Summary of Efficacy Results in BC Cohorts
Confirmed ORR by ICR (ORR, CR + PR)
n (%)
95% CI
Best overall response, n (%)
Cohort 1
HER2+
n = 32a
21 (65.6)
46.8-81.4
Cohort 2
HER2-low
n = 16
8 (50.0)
24.7-75.3
3 (9.4)
0
CR
PR
SD
PD
NE
18 (56.3)
8 (50.0)
9 (28.1)
4 (25.0)
2 (6.3)
2 (12.5)
0
Median DORb, months (95% CI)
Median PFS, months (95% CI)
NE (7.9-NE)
11.6 (6.9-NE)
2 (12.5)
5.5 (2.8-8.0)
7.0 (2.3-10.8)
Median TTR, months (range)
1.6 (1.2-5.5)
Median OS, months (95% CI)
NE (20.8-NE)
3.7 (2.6-9.8)
19.5 (2.7-NE)
Median treatment duration, months (range)
T-DXd
Nivolumab
8.9 (1-23)c
5.5 (1-23)
6.9 (1-21)
5.9 (1-14)
Daiichi-Sankyo
CR, complete response; DOR, duration of response; HER2, human epidermal growth factor receptor 2; ICR, independent central review; NE, not evaluable; ORR, objective response rate; OS, overall survival; PD, progressive
disease; PFS, progression-free survival; PR, partial response; SD, stable disease; T-DXd, trastuzumab deruxtecan; RDE, recommended dose for expansion.
aIncludes 3 patients treated at T-DXd 5.4 mg/kg RDE in combination with nivolumab 360 mg during part 1. bAmong patients with confirmed CR or PR. COnly includes the 29 patients treated at T-DXd 5.4 mg/kg RDE in
combination with nivolumab 360 mg during part 2.
ESMO BC 2022 #1620 Oral
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