DESTINY-Breast03 Phase 3 Study Results
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•
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TEAEs in Patients Treated with 4.8 mg/kg and 6.4 mg/kg
Daiichi-Sankyo
Gl and hematologic toxicity were the most
common TEAES
TEAES (≥25% of all patients), (%)
4.8 mg/kg
n=48
All grade
Grade ≥3
All grade
6.4 mg/kg
n=98
Grade ≥3
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Rates of non-hematologic toxicity were
similar at both doses and generally low
grade
Rates of grade ≥3 neutropenia,
thrombocytopenia and leukopenia were
numerically higher at 6.4 mg/kg vs 4.8
mg/kg
• All events were managed by dose delay or
reduction and were not associated with
treatment discontinuation
No grade ≥3 TEAE of thrombocytopenia
resulted in a grade ≥3 bleeding event
TEAES
Nausea
Alopecia
Malaise
97.9
64.6
100
81.6
68.8
4.2
80.6
5.1
Platelet count decreaseda
60.4
27.1
71.4
38.8
Neutrophil count decreaseda
62.5
27.1
66.3
52.0
Decreased appetite
56.3
6.3
53.1
6.1
Vomiting
47.9
4.2
46.9
1.0
White blood cell count decreaseda
45.8
10.4
45.9
23.5
Diarrhea
41.7
4.2
43.9
3.1
Anemiaa
43.8
20.8
43.9
21.4
Aspartate aminotransferase increased
Stomatitis
43.8
4.2
34.7
6.1
25.0
0.0
34.7
1.0
Fatigue
31.3
0.0
33.7
3.1
Alanine aminotransferase increased
41.7
2.1
31.6
7.1
Constipation
22.9
0.0
29.6
0.0
20.8
NA
28.6
ΝΑ
22.9
0.0
26.5
1.0
Gl, gastrointestinal; NA, not applicable.
a Grouped terms: platelet count decreased (platelet count decreased, thrombocytopenia); neutrophil count decreased (neutrophil count decreased, neutropenia); white blood cell count decreased (leukopenia, white
blood cell decreased); anemia (hemoglobin decreased, red blood cell count decreased, anemia, hematocrit decreased).
ASCO 2022 #1002 Oral
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