Investor Presentaiton
DS-7300
ES-SCLC Ph2 study
Development update
Ph2 dose-finding study for ES-SCLC was initiated in June
Ph1/2 study design
Dose escalation (Part 1)
Advanced/unresectable or
metastatic solid tumor
(various types of cancer)
0.8 mg
/kg
1.6 mg
/kg
3.2 mg
/kg
4.8 mg
/kg
Dose expansion (Part 2)
[Cohort 1] ESCC
[Cohort 2] CRPC
[Cohort 3] Squamous NSCLC
6.4 mg
/kg
ES-SCLC Ph2 study design
Daiichi-Sankyo
DS-7300 8mg/kg
16.0 mg
/kg
12.0 mg
/kg
ES-SCLC
2L or later
randomize
1:1
DS-7300 12mg/kg
8.0 mg
/kg
Primary endpoint: ORR
Secondary endpoint: PFS, DOR, OS, etc
ES-SCLC was selected
based on Ph1 data
N = 80
Extensive stage (ES) means cancer spreads across a wide area and
surgical operation and radiation therapy are not applicable
No effective treatment and high unmet need for ES-SCLC 2L or later
Efficacy and safety of two doses will be evaluated in Ph2 study in
patients with ES-SCLC who received at least one prior line of platinum-
based chemotherapy
Option for addition of 60 patient expansion at RP2D
CRPC: castration-resistant prostate cancer, DOR: duration of response, ESCC: esophageal squamous cell carcinoma, NSCLC: non small cell lung cancer, ORR: objective response rate, OS: overall survival,
PFS: progression free survival, RP2D: recommended Ph2 dose, SCLC: small cell lung cancer
29
29View entire presentation