TROPION-Lung01 Study Design and Baseline demographics
Overall Safety Summary
TRAES, n (%)
Dato-DXd
N=297
Docetaxel
N=290
•
257 (87)
252 (87)
All grades
Grade ≥3
73 (25)
120 (41)
Associated with dose reduction
58 (20)
85 (29)
•
Associated with dose delay
49 (17)
31 (11)
Associated with discontinuation
23 (8)
34 (12)
•
Associated with deatha
3 (1)
2 (1)
Serious TRAES
30 (10)
36 (12)
Grade ≥3
25 (8)
33 (11)
Daiichi-Sankyo
The median treatment durations for Dato-DXd
and docetaxel were 4.2 and 2.8 months,
respectively
Fewer grade ≥3 TRAES were observed with
Dato-DXd compared with docetaxel
Fewer TRAES leading to dose reductions or
discontinuations were seen with Dato-DXd
compared with docetaxel
ILD, interstitial lung disease; TRAE, treatment-related adverse event.
*Investigator assessed. Dato-DXd: 2 cases of ILD/pneumonitis and 1 case of sepsis; docetaxel: 1 case of ILD/pneumonitis and 1 case of septic shock.
The safety analysis set included all randomized patients who received 21 dose of the study drug.
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