Major R&D Pipeline: 3ADCs
ENHERTU®: Breast cancer
DESTINY-Breast03 study (HER2+, 2L, Ph3): TLR of interim analysis anticipated in FY2021 Q2 as originally planned
DESTINY-Breast09 study (HER2+, 1L, Ph3): First patient dosed in June
Daiichi-Sankyo
Presented interim results of BEGONIA study and subgroup analysis data of DESTINY-Breast01 study in patients with
brain metastasis at ASCO 2021
BEGONIA interim results (durvalumab combo)
20
DESTINY-Breast01 brain met subgroup analysis
100
80
n=15
Progressive Disease
Partial Response
-20
Change in target lesion from baseline (%)
-60
Best response
▲ Partial response (confirmed)
PD-L1 expression 5% cutoff
Unknown Negative
Positive
60
60
40
40
20
20
0
-20
-40
-60
-80
Stable Disease
-100
0
6
12
18
24
30
Weeks
36
42
48
54
HO
PD
SD
PR
60
60
* If the best percentage change from baseline of target lesions cannot be calculated due to progression, withdrawal or death, the value
is imputed at +20% Number of subjects that had the opportunity to complete at least two on-treatment disease assessments or have
PD or death
3 patients with reported baseline measurements had no change over time.
2 patients with brain metastases at baseline did not have sufficient data to evaluate response in the brain and are not shown.
● Stable disease (≥5 wks)
Progressive disease
-80-
Not yet evaluables
Durable responses were observed in patients with stable,
treated brain metastases.
The confirmed ORR was 66.7% in Arm 6 (HER2 low/ER-/PR-
BC, ENHERTU® + durvalumab) of BEGONIA study.
BC: breast cancer, ER: estrogen receptor, ORR: objective response rate, PR: progesterone receptor, TLR: top line results
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