Investor Presentaiton
ENHERTU
DESTINY-Breast03 safety data update
ASCO 2022 Highlights
The data reinforce the established favorable benefit/risk profile over T-DM1
in HER2+ BC
Safety update overview (Sep 7, 2021)
No new safety signals were observed for T-DXd
Adjudicated drug-related ILD/pneumonitis
■No Gr4/5 ILD/pneumonitis occurred in the T-DXd arm
Incidence rates of AEs were similar between the T-DXd and T-DM1
arms
T-DXd
T-DM1
n = 257
n = 261
n (%)
Any grade, n (%)
Patients discontinued from study treatment
141 (54.9)
222 (85.1)
Grade 1
Grade 2
Any grade TEAE
256 (99.6)
249 (95.4)
Grade 3
Grade 4
Grade 3 TEAE
137 (53.3)
130 (49.8)
Grade 5
Any grade serious TEAE
54 (21.0)
50 (19.2)
Time to first onset, median (range), days
Outcome of worst event, n (%)
Grade ≥3 serious TEAE
39 (15.2)
38 (14.6)
Fatal
Not recovered/not resolved
TEAE associated with drug discontinuation
38 (14.8)
19 (7.3)
Ongoing
Recovering/resolving
TEAE associated with dose reduction
59 (23.0)
36 (13.8)
Recovered/resolved with sequelae
Recovered/resolved
AE: adverse events, BC: breast cancer, TEAE, treatment-emergent adverse event.
T-DXd
T-DM1
n = 257
n = 261
28 (10.9)
5 (1.9)
7 (2.7)
4 (1.5)
19 (7.4)
1 (0.4)
2 (0.8)
0
0
0
0
0
181
(33-507)
289
(80-499)
0
8 (28.6)
0
2 (7.1)
2 (7.1)
16 (57.1)
1 (20.0)a
0
0
0
4 (80.0)
Daiichi-Sankyo
aPatient had an event of pulmonary embolism that the investigator considered to be grade 5. This was initially reported as respiratory failure
but subsequently updated to pulmonary embolism. The ILD adjudication committee adjudicated this event as drug-related grade 1 ILD/
pneumonitis. The death was not evaluable for adjudication. The investigator recorded disease progression as the primary cause of death.1
1. Cortés J et al. N Engl J Med. 2022;386:1143-1154 (supplementary appendix)
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