FY2022 Q3 Financial and R&D Update
FY2022, 2023 News Flow
Daiichi-Sankyo
As of Jan 2023
Key data readouts
EHHERTUⓇ
DESTINY-Breast06*: HR positive and HER2 low BC,
chemo naïve, Ph3
Planned major publications
JSMO (Mar 16-18, 2023)
HER3-DXd
Ph1 study: EGFR mutated NSCLC
• Data update of dose escalation cohort and dose expansion
cohort
Dato-DXd
•
FY2023 H1
TROPION-Lung01*: NSCLC, 2/3L, Ph3
•
FY2023 Q1
Regulatory decisions
ENHERTUⓇ
DESTINY-Breast04: HER2 low BC, post chemo, Ph3
JP: FY2022 Q4
.
DESTINY-Lung01, 02: HER2 mutant NSCLC, 2L+, Ph2
⚫ JP: FY2023 H1
•
EU: FY2023 H2
HER3-DXd
DS-5670
HERTHENA-Lung01: EGFR mutated NSCLC, 3L,
registrational Ph2
•
FY2022 Q4
Primary vaccination, original strain, Ph3
• FY2023 H1
Planned pivotal study initiation
Quizartinib
QUANTUM-First
AML, 1L, Ph3
•
JP/US: FY2023 H1
•
EU: FY2023 H2
FLUMISTⓇ
(VN-0107)
Nasal seasonal influenza vaccine
⚫ JP: FY2022 Q4
DS-5670
COVID-19 mRNA subvariant vaccine, booster study,
healthy volunteers, Ph3
•
FY2023 H1
Bold: update from FY2022 Q2
AML: acute myeloid leukemia, BC: breast cancer, JSMO: Japanese Society of Medical Oncology, NSCLC: non-small
cell lung cancer
Timeline indicated is based on the current forecast and subject to change.
*Event-driven study
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