TROPION-Lung01 Study Design and Baseline demographics
Efficacy Summary
Daiichi-Sankyo
Best Percent Change From Baseline in Sum of Diameters of Target Lesions
No. of prior systemic lines for
advanced or metastatic disease
1/2
23
n (%)
[95% CI]a
Median DOR
(95% CI), months
7.0
(4.2-9.8)
All
Response per
BICR
treated
Patients
with EGFR
Patients with
100.
patients
80-
(N=137)
60-
ORR confirmed,
49 (35.8)
[27.8-44.4]
mutations
(N=78)
34 (43.6)
[32.4-55.3]
7.0
(4.2-10.2)
ALK
rearrangement
(N=34)
8 (23.5)
[10.7-41.2]
7.0
(2.8-8.4)
Best percentchange
40-
20-
0-
-40-
-60-
-80-
+: Ongoing participant
-100-
DCR confirmed,
n (%)
108 (78.8)
[71.0-85.3]
64 (82.1)
[71.7-89.8]
25 (73.5)
[55.6-87.1]
[95% CI]a
+
+
+++
Patient
Percent Change From Baseline in Sum of Diameters of Target Lesions in
Patients With Confirmed CR/PR
Median PFS,
(95% CI),
monthsb
5.4
(4.7-7.0)
5.8
(5.4-8.3)
4.3
0
(2.6-6.9)
-25
BOR: In the overall population (N=137), 4 patients (3%)
achieved a CR and 45 (33%) achieved a PR
Percentchange
ã…Žã…Ž
-75
-50
Confirmed BOR
CR
PR
EGFR subset: Among patients with sensitizing or T790M
mutations (N=68), the ORR was 49.1% in those previously
treated with osimertinib
-100
-125
0
1
2
3
4
5
6 7
8 9 10 11 12 13 14
Months
15 16 17 18 19 20
BICR, blinded independent central review; BOR, best overall response; CR, complete response; DCR, disease control rate; DOR, duration of response; ORR, objective response rate; PFS, progression-free survival; PR,
partial response.
*The 2-sided 95% Cls are based on the Clopper-Pearson exact binomial method. "Median PFS and PFS probabilities are based on the Kaplan-Meier method. "Per BICR.
20
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