DESTINY-Breast03 Phase 3 Study Results
Most Reported Adverse Events (≥15% all grades)
Preferred term, n (%)
AEs all causes
Dato-DXd + D
N=29
All Grades,
Grade
Grade
Grade
≥15% of patients
1
2
3
Stomatitis
20 (69)
8 (28)
8 (28)
4 (14)
13
Alopecia
19 (66)
6 (21)
0
(45)
13
Nausea
19 (66)
6 (21)
(45)
Constipation
11 (38)
8 (28)
3 (10)
Fatigue
11 (38)
9 (31)
2 (6.9)
Rash
9 (31)
8 (28)
1 (3)
0
Vomiting
5 (17)
3 (10)
2 (6.9)
0
Data cutoff: November 15, 2021
0
O O O
0
0
◆ Low rates of diarrhea
reported (4 [14%]; all
Grade 1)
Daiichi-Sankyo
◆ No cases of ILD/pneumonitis
or neutropenic events were
reported
◆ 13.7% of patients required dose
reduction due to stomatitis
◆ Updated TMGs and prophylaxis
for stomatitis are being
implemented
ILD, interstitial lung disease; TMG, trial management guide.
ESMO BC 2022 #166 Mini Oral
80
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