FY2022 Q3 Financial and R&D Update
Major R&D Milestones (3ADCs)
Project
ENHERTUⓇ
Daiichi-Sankyo
As of Jan 2023
BC
•
•
•
Target Indication [phase, study name]
HER2+, 2L [Ph3, DESTINY-Breast03]
HER2 low, post chemo [Ph3, DESTINY-Breast04]
HER2 low, chemo naïve [Ph3, DESTINY-Breast06]
HER2+, 2L [Ph2, DESTINY-Gastric02, EU]
HER2 mutant, 2L [Ph2, DESTINY-Lung01, 02]
GC
•
NSCLC
•
CRC
•
HER2+, 3L [Ph2, DESTINY-CRC02]
FY2022
H2
FY2023
H1
H2
•
Approved (JP)
• Approved (EU)
• Approval anticipated
(JP)
• Approved (EU)
•
⚫ TLR anticipated
.
Filing accepted (JP/EU)
• Approval anticipated
(JP)
• Approval anticipated
(EU)
• TLR obtained
• 2/3L [Ph3, TROPION-Lung01]
NSCLC
Dato-DXd
•
1L [Ph3, TROPION-Lung07]
• Study started
BC
•
TNBC, adjuvant* [Ph3, TROPION-Breast03]
• Study started
•
EGFR mutated, 3L
HER3-DXd
NSCLC
[Registrational Ph2, HERTHENA-Lung01]
• TLR anticipated
•
TLR anticipated
Bold: update from FY2022 Q2
BC: breast cancer, CRC: colorectal cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer, TLR: Top Line Results, TNBC: triple-negative breast cancer
Timeline indicated is based on the current forecast and subject to change.
* Adjuvant therapy for patients with TNBC who have residual disease after neoadjuvant therapy
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