TROPION-Lung01 Study Design and Baseline demographics
Progression-Free Survival: ITT
100
80
Median (95% CI),
monthsa
HR
P-value
Dato-DXd
Docetaxel
4.4 (4.2-5.6) 3.7 (2.9-4.2)
0.75 (0.62-0.91)
PFS probability, %
60
50
40.8
40
30.1
20
20
+ Censored
28.2
17.8
0.004
Prespecified
0.008
boundary (2-sided)
0
T
0
2
со
8
10
No. at risk:
Time since randomization, months
Dato-DXd
299
216
156
96
74
46
Docetaxel
305
186
120
63
42
19
Dato-DXd
ORR (95% CI), %b
DOR (95% CI), mo
26.4 (21.5-31.8)
7.1 (5.6-10.9)
12
14
16
18
24
14
10
7
NO
2
0
O O
0
Docetaxel
12.8 (9.3-17.1)
5.6 (5.4-8.1)
CR, complete response; DOR, duration of response; HR, hazard ratio; ITT, intention to treat; ORR, objective response rate; PFS, progression-free survival; PR, partial response.
*Median PFS follow-up was 10.9 (95% CI, 9.8-12.5) and 9.6 (95% CI, 8.2-11.9) months for Dato-DXd and docetaxel, respectively. "Included 4 CRs and 75 PRs for Dato-DXd and 39 PRs for docetaxel.
Daiichi-Sankyo
9View entire presentation