Investor Presentaiton
Dato-DXd
Path for establishing 2L/3L treatment in NSCLC
TROPION-Lung 01 study
Disclosed TLR in July 2023
Daiichi-Sankyo
Major Ph3 Clinical Studies of Dato-DXd in NSCLC
Advanced/Metastatic
Advanced or
Dato-DXd
6.0 mg/kg
1L
24
2L
3L
Randomization
metastatic
1:1
NSCLC 2L/3L
Docetaxel
75 mg/m²
N = 600
TROPION-
Lung07
(PD-L1 <50%)
Primary: PFS, OS
Secondary: ORR, DOR, DCR, PK, safety etc.
NSCLC
without
AGA
Demonstrated statistically significant improvement in PFS
TROPION-
Lung08
(PD-L1 ≥ 50%)
TROPION-
Lung01
■No new safety signals identified, all grade ILD was generally
consistent with prior clinical trials with the majority being grade1 or 2.
Grade 5 ILD events were observed
■Proceeding to file the data with FDA
NSCLC
with
AGA
AGA: actionable genomic alteration, DCR: Disease Control Rate, DoR: Duration of Response, FDA: U.S. Food and Drug Administration, ILD: interstitial lung disease, NSCLC: Non-small Cell Lung Cancer, ORR: Overall Response Rate, OS:
Overall Survival, PFS: Progression Free Survival, PK: Pharmacokinetics, TLR: Top Line Results
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