Investor Presentaiton
ENHERTU
DESTINY-Breast04 study
Daiichi-Sankyo
Pioneer HER2 low BC as a new clinically meaningful patient segment
■ENHERTUⓇ met the primary endpoint and all key secondary endpoints in the global
Ph3 study for patients with HER2 low breast cancer previously treated with
chemotherapy
■ENHERTUⓇ is the first and only HER2-directed therapy to demonstrate a survival
benefit for patients with HER2 low breast cancer. In Jun 2022, ENHERTUⓇ was listed in US
NCCN guidelines as preferred regimen (category 1) for HER2 low breast cancer
previously treated with chemotherapy
■ About 50% of all breast cancer patients are reclassified as HER2 low, a new targetable
patient segment
Regulatory submission status in each countries
―
Jun 2022: Filing accepted in JP & EU
- Jul 2022: Filing accepted and granted priority review in US (PDUFA date Nov 26)
-
FY2022 Q2: Filing planned in China
HER2 positive
IHC 3+
IHC 2+/ISH+
HER2 low
IHC 2+/ISH-
IHC 1+
~50%
HER2 negative
IHC<1+
BC: breast cancer, NCCN: National Comprehensive
Cancer Network
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