TROPION-Lung01 Study Design and Baseline demographics
Efficacy endpoint: PFS and OS by HER2 status
Daiichi-Sankyo
K-M estimates of PFS by investigator assessment (All cohorts)
1.0
0.8
Median PFS in months (95% CI)
All cohorts: IHC 3+ 11.9 (8.2, 13.0)
All cohorts: IHC 2+ 5.4 (4.2, 6.0)
All cohorts: Total 6.9 (5.6, 8.0)
PFS events, n (%): 203 (76%)
Probability of PFS
0.6
0.4
0.2-
0.0
0
3
53%
30%
21%
T
6
9
12
15
18
21
Time from first dose (months)
15%
24
24
27
30
33
Probability of OS
1.0
0.8-
0.6
0.2 -
K-M estimates of OS (All cohorts)
Median OS in months (95% CI)
― All cohorts: IHC 3+ 21.1 (15.3, 29.6)
All cohorts: IHC 2+ 12.2 (10.7, 13.5)
All cohorts: Total 13.4 (11.9, 15.5)
OS events, n (%): 176 (66%)
0.0
0
-3
75%
9
56%
39%
30%
T
T
24 27
30
33
12 15 18 21
Time from first dose (months)
Number at risk, month
Number at risk, month
All cohorts: IHC 3+ 75 63
51
39
34
23
19
12
1 0
All cohorts: IHC 2+ 125
78 50
31
20
18
13
9
3
1
0
All cohorts: IHC 3+ 75
All cohorts: IHC 2+ 125
69 61
56
51 45 39
29
113
88
75
62
43
31
All cohorts: Total 267 185
132
89
68
51
39
25
6
2
10
All cohorts: Total 267 239
194
165
143
108 86 65 34 10
228
13
4
20
22
12
UN
2
0
4 0
Circle indicates a censored observation
CI, confidence interval; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; K-M, Kaplan-Meier; OS, overall survival; PFS, progression-free survival
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