TROPION-Lung01 Study Design and Baseline demographics
Daiichi-Sankyo
Dato-DXd (n=360)
ICC (n=351)
Preferred term, n (%)
Any Grade Grade ≥3 Any Grade Grade ≥3
Blood and lymphatic system
Anaemia
40 (11)
4 (1)
69 (20)
Neutropenia*
39 (11)
4 (1)
149 (42)
Eye
Dry eye
78 (22)
2 (1)
27 (8)
Gastrointestinal
Nausea
184 (51)
5 (1)
83 (24)
Stomatitis
180 (50)
23 (6)
46 (13)
Vomiting
71 (20)
4 (1)
27 (8)
Constipation
65 (18)
0
32 (9)
TRAES Occurring in ≥15% of Patients and AESIS
System Organ Class
•
• Most TRAEs were grade 1-2 and manageable
AESIs
Oral mucositis/stomatitis: led to treatment
discontinuation in one patient in the Dato-DXd
group
Ocular events: most were dry eye; one patient
discontinued treatment in the Dato-DXd group
Adjudicated drug-related ILD:S rate was low;
mainly grade 1/2
7 (2)
•
108 (31)
0
2 (1)
9 (3)
•
2 (1)
0
General
Fatigue
Skin and subcutaneous
Alopecia
85 (24)
6 (2)
64 (18)
7 (2)
Adjudicated drug-related ILD Dato-DXd
ICC
All grades, n (%)
9 (3)
0
131 (36)
0
72 (21)
0
Grade ≥3, n (%)
2 (1)1
0
*Neutropenia includes the PTs neutropenia and neutrophil count decreased. "Oral stomatitis/mucositis events included PTs of aphthous ulcer, dysphagia, glossitis, mouth ulceration, odynophagia, oral mucosal blistering, oral pain, oropharyngeal pain, pharyngeal inflammation,
stomattis, tongue ulceration; all grade: 59% with Dato-DXd, 17% with ICC; grade 3: 7% with Dato-DXd, 3% with ICC. #Ophthalmologic assessments were required at screening, and then every 3 cycles from C1D1 and at end of therapy; ocular events included selected PTs from
Corneal Disorder SMQ and select relevant PTs from Eye Disorder SOC; all grade: 49% with Dato-DXd, 23% with ICC; grade 3: 1% with Dato-DXd (one patient with dry eye, one patient with punctate kerattis, and one patient with dry eye and ulcerative kerafts), 0% with ICC.
$ILD includes events that were adjudicated as ILD and related to use of Dato-DXd or ICC (includes cases of potential ILD/pneumonitis, based on MedDRA v23.0 for the narrow ILD SMQ, selected terms from the broad ILD SMQ, and PTs of respiratory failure and acute
respiratory failure). One adjudicated drug-related grade 5 ILD event attributed to disease progression by investigator. ILD, interstitial lung disease; PTs, preferred terms; SMQ, standard MedDRA query; SOC, system organ class.
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