TROPION-Lung01 Study Design and Baseline demographics
Daiichi-Sankyo
Adverse Events of Special Interest
Dato-DXd
N=297
Docetaxel
N=290
AESI, n (%)
Stomatitis/oral mucositisa
All grades
160 (54)
59 (20)
Grade ≥3
19 (6)
4 (1)
Ocular eventsb
All grades
57 (19)
27 (9)
Grade ≥3
5 (2)c
0
Adjudicated drug-related ILDd
25 (8)
12 (4)
All grades
Grade ≥3
Grade 5
10 (3)
7 (2)
4 (1)
1 (0.3)
•
Stomatitis/oral mucositis associated with Dato-DXd
resulted in a low rate of discontinuation (0.7%)
Dry eye was the most common ocular event seen with
Dato-DXd (6.1%; primarily grade ≤2), followed by
increased lacrimation (5.4%)
Seven adjudicated drug-related grade 5 ILD events
•
•
Primary cause of death in 4 out of 7 was
attributed to disease progression by investigator
Non-squamous: 4 of 232 patients (1.7%);
Squamous: 3 of 65 patients (4.6%)e
IRRs were observed in 24 patients (8%) with either
Dato-DXd or docetaxel; all were grade ≤2 with the
exception of 1 grade 3 event
AESI, adverse event of special interest; ILD, interstitial lung disease; IRR, infusion-related reaction; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SMQ, standardized MedDRA query; SOC, system
organ class. AESIs listed in this slide are treatment emergent and include all PTs that define the medical concept.
*Events included the selected PTs oral mucositis/stomatitis, oropharyngeal pain, mouth ulceration, odynophagia, dysphagia, oral pain, glossitis, pharyngeal inflammation, aphthous ulcer, and oral mucosa erosion. "Ocular events
included selected PTs from the corneal disorder SMQ and selected relevant PTs from the eye disorder SOC. "Included 4 cases of keratitis and 1 case of ulcerative keratitis. "ILD includes events that were adjudicated as ILD and
related to use of Dato-DXd or docetaxel (includes cases of potential ILD/pneumonitis based on MedDRA v26.0 for the narrow ILD SMQ, selected terms from the broad ILD SMQ, and PTs of respiratory failure and acute
respiratory failure). *Among treated patients, histology information per the case report form.
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