TROPION-Lung01 Study Design and Baseline demographics
BEGONIA Arm 7: Dato-DXd + Durvalumab
Adverse Events
Most frequently reported adverse events (≥15%) (N=62)
The most common AEs were gastrointestinal and generally
of low grade (Table)
AE preferred term
Any grade, n (%)
Grade 3/4, n (%)
Nausea
40 (65)
0
Stomatitis
40 (65)
7 (11)
Alopecia
31 (50)
0
Constipation
29 (47)
1 (2)
Fatigue
28 (45)
Rash
20 (32)
1 (2)
0
Vomiting
16 (26)
1 (2)
Amylase increased
13 (21)
11 (18)
COVID-19
13 (21)
0
Dry eye
13 (21)
0
Decreased appetite
12 (19)
1 (2)
Pruritus
10 (16)
0
Cough
10 (16)
0
AE, adverse event; AESI, adverse event of special interest; ILD, interstitial lung disease.
Stomatitis was the most common AE leading to Dato-DXd
dose reduction (11 patients)
There were 3 (5%) adjudicated treatment-related
ILD/pneumonitis events (2 grade 2 events, 1 grade 1 event)
Limited rates of diarrhea (13% any grade, 1 grade 3 event)
and neutropenia (5% any grade, 1 grade 3 event) were
reported
The most frequent AESIS for Arm 7 were stomatitis (65%),
rash (32%), dry eye (21%), hypothyroidism (14.5%), and
keratitis (14.5%)
Daiichi-Sankyo
Data cutoff: 02 Feb 2023
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