TROPION-Lung01 Study Design and Baseline demographics
Efficacy Analysis in Select Tumor Types (≥4.8 mg/kg cohort)
A) SCLC³
100
Starting dose level
SCLC
n=21
11 (52.4; 29.8-74.3)
1 (4.8)
10 (47.6)
Efficacy population (24.8 mg/kg)
80
6.4 mg/kg 8.0 mg/kg 120 mg/kg
16.0 mg/kg
Confirmed ORR, n (%; 95% CI)
60
40
Confirmed CR, n (%)
Confirmed PR, n (%)
TTR, median (95% CI), months
DOR, median (95% CI), months
1.2 (1.2-1.4)
•
5.9 (2.8-7.5)
2
& 9
Median PFS, months (95% CI)
5.6 (3.9-8.1)
Median OS, months (95% CI)
12.2 (6.4-NE)
Best percentage change in sum of
diameters from baseline in target
Jesions
-100
Daiichi-Sankyo
Follow-up, median (95% CI), months
Safety population (all doses)
Number of prior systemic regimens, median (range)
Platinum-based chemotherapy, n (%)
Immunotherapy, n (%)
Irinotecan or topotecan, n (%)
Topotecan, n (%)
11.7 (4.6-12.9)
n=22
2 (1-7)
22 (100)
18 (81.8)
5 (22.7)
3 (13.6)
In the ≥4.8 mg/kg population, the confirmed ORR was 27.3%
(38/139; 95% CI: 20.1%-35.5%)
• ORRS in the tumor types selected in this analysis were as follows:
-SCLC: 11/21 (52%) patients achieved a PR (n=10) or CR (n=1)
-ESCC: 6/28 (21%) patients achieved a PR
See next slide for mCRPC and sqNSCLC
"One patient received both.
Change from baseline in target lesions was assessed per RECIST v1.1. All 21 patients were evaluable at baseline, but one did not have any post-baseline
tumor assessments, and so was not included in the waterfall plot.
B) ESCC
100
Starting dose level
80
14.8 mg/kg 8.0 mg/kg 120 mg/kg
8
9 &
0
Best percentage change in sum of
diameters from baseline in target
Jesions
Efficacy population (24.8 mg/kg)
Confirmed ORR, n (%; 95% CI)
Confirmed PR, n (%)
TTR, median (95% CI), months
DOR, median (95% CI), months
ESCC
n=28
6 (21.4; 8.3-41.0)
6 (21.4)
1.4 (1.2-NE)
3.5 (2.4-NE)
Median PFS, months (95% CI)
2.8 (2.1-5.5)
Median OS, months (95% CI)
7.0 (4.8-12.2)
Follow-up, median (95% CI), months
14.9 (6.3-NE)
Safety population (all doses)
n=29
Number of prior systemic regimens, median (range)
Cisplatin/carboplatin/oxaliplatin, n (%)
4 (1-7)
29 (100)
Taxane, n (%)
21 (72.4)
Immunotherapy, n (%)
-100
27 (93.1)
Change from baseline in target lesions was assessed per RECIST v1.1. Of 28 patients with measurable disease at baseline, three did not have post-baseline tumor
assessments, and so were not included in the waterfall plot.
the
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