TROPION-Lung01 Study Design and Baseline demographics
Daiichi-Sankyo
Safety profile of R-DXd is manageable
Patients with OVC who received R-DXd at 4.8-8.0 mg/kg
Overview of TEAES
n (%)
N=60
Most common (≥10%) treatment-related TEAES
Preferred term
n (%)
N=60
Any TEAEs
57 (95.0)
All
grades
Grade
≥3
TEAE with CTCAE Grade ≥3
31 (51.7)
TEAE associated with drug discontinuation
9 (15.0)
Nausea
35 (58.3)
1 (1.7)
TEAE associated with dose interruption
22 (36.7)
Fatigue
27 (45.0)
2 (3.3)
Vomiting
20 (33.3)
1 (1.7)
TEAE associated with dose reduction
15 (25.0)
"
Any treatment-related CTCAE Grade ≥3 TEAE
Treatment-related TEAE associated with death
•
要
3.3% (2/60) of patients in the 4.8-8.0 mg/kg cohort experienced Grade 5 ILD;
both occurred in the 8.0 mg/kg cohort and were adjudicated as treatment-related
8.9% (4/45) of patients in the 4.8-6.4 mg/kg cohort experienced
ILD (all Grade 2), of which 2 were adjudicated as treatment-related
As of October 2022, the 8.0 mg/kg cohort was closed due to a higher incidence
of serious and Grade ≥3 TEAEs and lack of a favorable benefit/risk ratiob
Further dose assessment is ongoing at three doses: 4.8, 5.6 and 6.4 mg/kg
Data cutoff: July 14, 2023.
"Grade 5 ILD. 6/15 (40.0%) patients in the 8.0-mg/kg OVC cohort experienced serious and Grade 23 TEAEs.
CTCAE, Common Terminology Criteria for Adverse Events; ILD, interstitial lung disease; OVC, ovarian cancer; TEAE, treatment-emergent adverse event.
Alopecia
Malaise
22 (36.7)
Anemia
17 (28.3)
11 (18.3)
2 (3.3)a
Decreased neutrophil count
15 (25.0)
7 (11.7)
Diarrhea
16 (26.7)
1 (1.7)
Decreased appetite
15 (25.0)
1 (1.7)
Decreased platelet count
10 (16.7)
3 (5.0)
7 (11.7)
0
6 (10.0)
0
56
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