TROPION-Lung01 Study Design and Baseline demographics
Objective response and duration of response
Daiichi-Sankyo
100
Endometrial
Cervical
Ovarian
Bladder
Othera
BTC
Pancreatic
90
84.6
75.0
Confirmed ORR by
investigator
(%)
80
70
57.5
63.6
60
56.3
56.3
50
40
30
20
50.0
47.1
45.0
40.0
39.0
36.8
35.0
10
All
IHC 3+
IHC 2+
All
IHC 3+
IHC 2+
קון
IHC 3+
IHC 2+
All
IHC 3+
IHC 2+
All
IHC 3+
30.0
44.4
0° IHC 2+
18.8
22.0
All
IHC 3+
IHC 2+
All
IHC 3+
IHC 2+
4.0
5.3
0.0
0.0
0
n= 40
13 17
40
8
00
20
40
Median DOR,
months (95% CI)b
NR
(9.9, NR)
14.2
11 19
11.3
41
16
20
40
9
16
41
16
14
25
2 19
8.7
22.1
8.6
5.7
(4.1, NR)
(4.1, 22.1)
(4.3, 11.8)
(4.1, NR)
(2.1, NR)
(NR, NR)
All patients (N=267)
IHC 3+ (n=75)
IHC 2+ (n=125)
ORR,% (95% CI)
37.1 (31.3, 43.2)
11.3 (9.6, 17.8)
61.3 (49.4, 72.4)
27.2 (19.6, 35.9)
22.1 (9.6, NR)
Median DOR, months (95% CI)b
9.8 (4.3, 12.6)
Analysis of ORR by investigator was performed in patients who received >1 dose of T-DXd; all patients (n=267; including 67 patients with IHC 1+ [n=25], IHC 0 [n=30], or unknown IHC status [n=12] by central testing) and patients with centrally
confirmed HER2 IHC 3+ (n=75) or IHC 2+ (n=125) status. Analysis of DOR was performed in patients with objective response who received ≥1 dose of T-DXd; all patients (n=99; including 19 patients with IHC 1+ [n=6], IHC 0 [n=9], or unknown IHC
status [n=4] by central testing) and patients with centrally confirmed HER2 IHC 3+ (n=46) or IHC 2+ (n=34) status. *Responses in extramammary Paget's disease, head and neck cancer, oropharyngeal neoplasm, and salivary gland cancer,
bincludes patients with a confirmed objective response only
BTC, biliary tract cancer; CI, confidence interval; DOR, duration of response; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; NR, not reached; ORR, objective response rate; T-DXd, trastuzumab deruxtecan
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