FY2022 Q3 Financial and R&D Update
ENHERTUⓇ
Progression-Free Survival Probability, %
DESTINY-Breast03 Study
SABCS 2022
Efficacy (PFS)
Efficacy (OS)
T-DXd
T-DM1
T-DXd
T-DM1
100-
Median
(95% CI),
months
28.8
(22.4-37.9)
6.8
(5.6-8.2)
T-DXd: 94.1% (95% CI, 90.4-96.4)
T-DM1: 86.0% (95% CI, 81.1-89.8)
100-
80
T-DXd: 75.2% (95% CI, 69.3-80.2)
T-DM1: 33.9% (95% CI, 27.7-40.2)
HR
P
0.33 (95% CI, 0.26-0.43)
<0.000001a,b
T-DXd: 53.7% (95% CI, 46.8-60.1)
T-DM1: 26.4% (95% CI, 20.5-32.6)
60
40
++
20
0 1
Censor
T-DXD (n = 261)
T-DM1 (n = 263)
2 3 4 5
67
8
Overall Survival Probability,%
T-DXd: 77.4% (95% CI, 71.7-82.1)
T-DM1: 69.9% (95% CI, 63.7-75.2)
Median
(95% CI),
months
NR
(40.5-NE)
NR
(34.0-NE)
80-
HR
P
0.64 (95% CI, 0.47-0.87)
0.0037a,b
60
40
0
Censor
T-DXd (n = 261)
T-DM1 (n = 263)
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47
Anti-cancer therapies in post trial setting:
T-DXd arm: 64/182 (35.2%) received T-DM1
⚫ T-DM1 arm: 42/243 (17.3%) received T-DXd
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45
Time, months
DESTINY-Breast03 Study
Time, months
Comparative study of ENHERTUⓇ and T-DM1 as a 2nd line treatment in patients with HER2 positive recurrent metastatic BC
ENHERTUⓇ reduced the risk of death by 36% (HR: 0.64)
■mPFS with ENHERTUⓇ was 4 times longer than with T-DM1 (28.8 months vs. 6.8 months)
■ORR was 78.5%; 1 in 5 (21%) patients experienced CR
Data Cutoff: July 25, 2022
The safety profile observed with ENHERTU® in DESTINY-Breast03 was consistent with previous clinical trials with no new safety concerns
identified
Groundbreaking survival supports ENHERTUⓇ as the 2L SOC in HER2+ BC
BC: breast cancer, Cl: confidence interval, CR: complete response, HR: hazard ratio, ILD: interstitial lung disease, mPFS: median progression-free survival, ORR: objective response rate, OS: overall survival, PFS: progression-free
survival, NE: not estimable, NR: not reached, SABCS: San Antonio Breast Cancer Symposium, SOC: standard of care, T-DM1: trastuzumab emtansine, T-DXd: trastuzumab deruxtecan
Daiichi-Sankyo
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