DESTINY-Breast03 Phase 3 Study Results
Adjudicated Drug-Related ILD/Pneumonitis
Any grade, n (%)
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Time to first onset, median (range), days
Outcome of worst event, n (%)
Fatal
Not recovered/not resolved
Ongoing
Recovering/resolving
Recovered/resolved with sequelae
Recovered/resolved
10
Daiichi-Sankyo
DESTINY-Breast03
T-DXd
n = 257
T-DM1
n = 261
For this safety update:
•
Majority of adjudicated
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
1 (20.0)a
0
0
2 (7.1)
0
2 (7.1)
16 (57.1)
0
4 (80.0)
ILD/pneumonitis cases were low
grade and no new grade 4 or 5
events occurred in either treatment
arm
One additional grade 2 adjudicated
drug-related ILD/pneumonitis
occurred
The majority of events resolved
with ongoing follow-up
ILD, interstitial lung disease; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan.
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).
Safety update: Sept 7, 2021
ASCO 2022 #1000 Oral
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