DESTINY-Breast03 Phase 3 Study Results
Adverse Events of Special Interest:
ILD/Pneumonitis and LV Dysfunction
Overall
N = 48c
n (%)
Adjudicated as Drug-related ILD/Pneumonitisa,b
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Any
Grade/Total
0
6 (12.5)d
0
0
1 (2.1)
7 (14.6)
• Median time to adjudicated onset was 168 days (range, 40-250 days)
A grade 3 adjudicated drug-related ILD/pneumonitis event also occurred in 1 patient (25.0%) with BC
who received 3.2 mg/kg T-DXd in combination with nivolumab in part 1
LV Dysfunction
• In cohort 1, 2 patients (6.9%) experienced an LV dysfunction evente,f
• No patients in cohort 2 experienced LV dysfunction
BC, breast cancer; HER2, human epidermal growth factor receptor 2; ILD, interstitial lung disease; LV, left ventricular; RDE, recommended dose for expansion; T-DXd, trastuzumab deruxtecan.
aCases of potential ILD or pneumonitis were evaluated by an independent adjudication committee that was separate from the response assessment committee. Data shown here are for cases that were
deemed drug-related by the adjudication committee. The adjudication committee did not discriminate between T-DXd and nivolumab-related ILD/pneumonitis. Includes all patients with BC who received
T-DXd 5.4 mg/kg RDE in combination with nivolumab 360 mg in parts 1 and 2. d2 grade 1 ILD events by the principal investigator were adjudicated as grade 2. ePer Standardized Medical Dictionary of
Regulatory Activities Query of Cardiac Failure and of Myocardial Infarction. f1 asymptomatic ejection fraction decreased (grade 2) and 1 troponin T increased (grade 3). Neither events recovered and 1
patient discontinued treatment.
ESMO BC 2022 #1620 Oral
Daiichi-Sankyo
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