Investor Presentaiton
Major R&D Milestones (3ADCs)
Project
ENHERTUⓇ
Target Indication [phase, study name]
•
HER2+, 3L [P3, DESTINY-Breast02]
•
HER2+, 2L [P3, DESTINY-Breast03]
FY2022
H1
• TLR anticipated
• Approved (US/EU)
BC
GC
NSCLC
•
•
•
HER2 low, Post chemo [P3, DESTINY-Breast04]
HER2 low, chemo naïve [P3, DESTINY-Breast06]
HER2+, 2L [P2, DESTINY-Gastric02, EU]
HER2 mutated, 2L [P2, DESTINY-Lung01]
HER2 mutated, 2L [P2, DESTINY-Lung05, CN]
.
Filing accepted (JP/US/EU)
.
Filing planned (CN)
• Filing accepted (US)
• Approval anticipated (US)
• Study start planned
NSCLC
• 2/3L [P3, TROPION-Lung01]
H2
HH
As of Jul 2022
FY2023
Daiichi-Sankyo
• Approval
anticipated (JP)
• Approval
anticipated (US)
• Approval
anticipated (EU)
• Approval
anticipated (JP/EU)
⚫TLR anticipated
•
TLR anticipated
Dato-DXd
BC
•
TNBC, 1L, [P3, TROPION-Breast02]
Solid
tumors
HER3-DXd
NSCLC
Bold: update from FY2021 Q4
• NSCLC, TNBC [P1/2, TROPION-Pan Tumor02, CN]
•
•
• EGFR mutated, 3L
[Registrational P2, HERTHENA-Lung01]
EGFR mutated, 2L [P3, HERTHENA-Lung02]
⚫ Study started
•
Study started
• Study start planned
BC: breast cancer, GC: gastric cancer, NSCLC: non small cell lung cancer, TLR: top line results
The timeline indicated is based on the current forecast and subject to change.
• TLR anticipated
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