TROPION-Lung01 Study Design and Baseline demographics
Safety Summary
TEAEs Occurring in ≥15% of Patients;
All Grades (N=137) a
Nausea
35
23
2
Stomatitis
29
20
10
Alopecia
36
16b
Constipation
23
9
Decreased appetite
12 12 4
Fatigue 12
21
10 4
Vomiting
14 8 1
Anemia
456
Daiichi-Sankyo
137 patients (100%) experienced TEAEs (grade ≥3, 47%)
• 129 (94%) experienced treatment-related TEAEs (grade ≥3, 29%)
• 34 (25%) experienced serious AEs (grade ≥3, 5%)
• 30 (22%), 13 (10%), and 2 (2%) patients experienced TEAES
associated with dose reduction, dose withdrawal, and death,c
respectively
AESI Incidence by Graded
n(%)
Total
Grade 1
Grade 2
Grade ≥3
Grade 1
Oral mucositis/stomatitis
90 (66)
45 (33)
30 (22)
15 (11)
Grade 2
Grade ≥3
Ocular surface toxicity
36 (26)
26 (19)
7 (5)
3 (2)f
IRR
22 (16)
15 (11)
7 (5)
0
Adjudicated drug-related
5 (4)
1 (1)
3 (2)
1 (1)g
ILD
Asthenia 7 7
COVID-19
10 5 1
21
Rash
12 4
Cough
10 4
0
20
40
Patients, %
60
AE, adverse event; AESI, adverse event of special interest; CTCAE, common terminology criteria for adverse event; ILD, interstitial lung disease; IRR, infusion-related reaction; TEAE, treatment-emergent adverse event.
"Due to rounding, summed rates may not reflect total percentage of TEAES. "Includes an event reported as Grade 3 incorrectly per CTCAE grades. "Two deaths were associated with disease progression, unrelated to study drug by investigator. "AESIs
listed in this slide include all preferred terms defined by the medical concept. "Dry eye was the most commonly reported ocular surface toxicity (n=15 [11%]). Patients with grade 3 ocular surface toxicity had corneal disorder, cornea verticillata, and
punctate keratitis. "One case of ILD was reported as a grade 3 event by investigator, and the patient died due to disease progression per investigator. The same event was adjudicated as a grade 5 event.
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