TROPION-Lung01 Study Design and Baseline demographics
Efficacy Analysis in Select Tumor Types (≥4.8 mg/kg cohort)
C) mCRPC
Starting dose level
Best percentage change in sum of
diameters from baseline in target
Jesions
100
Efficacy population (24.8 mg/kg)
80
6.4 mg/kg 8.0 mg/kg
12.0 mg/kg
16.0 mg/kg
Confirmed ORR, n (%; 95% CI)-
Confirmed PR, n (%)
60
40
Confirmed ORR in patients with liver mets at
baseline (27/59, 45.8% of mCPRC efficacy
population 24.8 mg/kg), n (%)
8
0
8 9
80
TTR, median (95% CI), months*
DOR, median (95% CI), months-
Median PFS, months (95% CI)
Daiichi-Sankyo
mCRPC
n=73
15 (25.4; 15.0-38.4)
15 (25.4)
9 (33.3)
1.4 (1.2-2.6)
6.4 (3.0-10.0)
5.3 (4.1-6.9)
13.0 (10.3-16.0)
16.6 (14.5-18.6)
⚫The sqNSCLC expansion cohort was the latest expansion cohort to
open and is ongoing, hence the relatively short duration of follow-up
.
ORRS in the tumor types selected in this analysis were as follows:
-mCRPC: 15/59 (25%) patients achieved a PR
-sqNSCLC: 4/13 (31%) patients achieved a PR
Median OS, months (95% CI)b
Follow-up, median (95% CI), months
Safety population (all doses)
n=75
Number of prior systemic regimens, median (range)
Taxane, n (%)
NHA_n (%)
6 (1-11)
61 (81.3)
72 (96.0)
-100
"The ORR is calculated based on 59 patients who received 21 dose 24.8 mg/kg, had measurable disease at baseline, >2 postbaseline scans, and/or
discontinued treatment for any reason at data cutoff. *n=73, including patients with bone metastases who were not evaluable for ORR
Change from baseline in target lesions was assessed per RECIST v1.1. Two patients did not have any post-baseline tumor assessments and were not included in the
waterfall plot.
D) sqNSCLC
100
Starting dose level
Efficacy population (24.8 mg/kg)
Best percentage change in sum of
diameters from baseline in target
lesions,
-20
89
8 8
80
4.8 mg/kg 12.0 mg/kg
16.0 mg/kg
60
40
Confirmed ORR, n (%; 95% CI)
Confirmed PR, n (%)
TTR, median (95% CI), months
20
0
-100
DOR, median (95% CI), months
Follow-up, median (95% CI), months
Safety population (all doses)
Number of prior systemic regimens, median (range)
Platinum-based chemotherapy, in (9)
Immunotherapy, n (%)
Taxane, n (%)
sqNSCLC
n=13
4 (30.8, 9.1-61.4)
4 (30.8)
1.3 (0.7-NE)
4.1 (2.8-NE)
5.2 (1.7-NE)
n=18
3 (1-12)
18 (100)
18 (100)
16 (88.9)
Change from baseline in target lesions was assessed per RECIST v1.1. One patient did not have any post-baseline tumor assessments and was not included in
waterfall plot. Since enrollment in the sqNSCLC cohort is ongoing, analyses of PFS and OS in this cohort are not yet mature.
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