TROPION-Lung01 Study Design and Baseline demographics
Safety summary
Most common drug-related TEAEs (>10%)
Daiichi-Sankyo
n (%)
All patients
(N=267)
Nausea 3.7
55.1
Fatigueb
7.1
40.1
Any drug-related TEAES
226 (84.6)
Neutropenia
19.1
32.6
Anemia
10.9
27.7
Drug-related TEAEs Grade ≥3
109 (40.8)
Diarrhea 3.7
Vomiting 1.5
Serious drug-related TEAES
36 (13.5)
Decreased appetite
1.5
755
25.8
24.7
17.6
Thrombocytopeniad 5.6
17.2
Drug-related TEAEs associated
with dose discontinuations
23 (8.6)
Drug-related TEAEs associated
with dose interruptions
54 (20.2)
Alopecia
Increased transaminasese 0.4
Leukopenia 2.6
0
16.9
10.1
Grade ≥3
Any grade
10.1
10
30
20
40
Patients experiencing drug-related TEAEs (%)
50
60
Drug-related TEAEs associated
54 (20.2)
with dose reductions
ILD/pneumonitis adjudicated
Drug-related TEAEs associated
4 (1.5)a
with deaths
as T-DXd related, n (%)
All patients (N=267)
Grade 1
7 (2.6)
Grade 2
17 (6.4)
Grade 3
1 (0.4)
Grade 4
0
Grade 5
3 (1.1)
Any grade
28 (10.5)
Analyses were performed in patients who received 21 dose of T-DXd (N=267); median total treatment duration 5.6 months (range 0.4-31.1)
*Included pneumonia (n=1), organizing pneumonia (n=1), pneumonitis (n=1), and neutropenic sepsis (n=1); 'category includes the preferred terms fatigue, asthenia, and malaise; "category includes the preferred terms neutrophil count decreased and
neutropenia; "category includes the preferred terms platelet count decreased and thrombocytopenia; "category includes the preferred terms aspartate aminotransferase increased, alanine aminotransferase increased, gamma-glutamyltransferase
increased, hypertransaminasemia; fcategory includes the preferred terms white blood cell count decreased and leukopenia
ILD, interstitial lung disease; T-DXd, trastuzumab deruxtecan; TEAE, treatment-emergent adverse event
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