Major R&D Pipeline: 3ADCs
(occurring in ≥20% of patients
DS-3201 Ph1: Most Common TEAEs
Most Common TEAEs
All Histologies
(N=77)
PTCL
(N=44)
with TCL)b
All grades
Grade ≥3
All grades
Grade ≥3
All grades
ATL
(N=14)
Grade ≥3
Platelet count decreasedd
47 (61.0)
13 (16.9)
21 (47.7)
5 (11.4)
9 (64.3)
3 (21.4)
Dysgeusia
40 (51.9)
0
20 (45.5)
0
8 (57.1)
0
Anemia
31 (40.3)
9 (11.7)
15 (34.1)
6 (13.6)
5 (35.7)
1 (7.1)
Neutrophil count decreased
27 (35.1)
18 (23.4)
13 (29.5)
8 (18.2)
6 (42.9)
5 (35.7)
Alopecia
26 (33.8)
0
12 (27.3)
0
6 (42.9)
0
WBC count decreased
23 (29.9)
12 (15.6)
10 (22.7)
6 (13.6)
4 (28.6)
3 (21.4)
Diarrhea
22 (28.6)
1 (1.3)
13 (29.5)
0
3 (21.4)
0
Lymphocyte count decreased
22 (28.6)
17 (22.1)
7 (15.9)
6 (13.6)
2 (14.3)
2 (14.3)
ALT increased
16 (20.8)
1 (1.3)
7 (15.9)
0
3 (21.4)
Nausea
16 (20.8)
0
11 (25.0)
0
3 (21.4)
1 (7.1)
0
Daiichi-Sankyo
ALT alanine aminotransferase; BCL, B-cell lymphoma; CTCAE, Common Terminology Criteria for Adverse Events; TEAE, treatment emergent adverse events; WBC, white blood cell.
a Study sites could choose to enter thrombocytopenia or platelet count decreased as a term. b In order of frequency reported for patients with TCL (n=58). c Including 19 patients with BCLs. d Grade 3 platelet count decreased,
CTCAE 5.0 definition: <50,000-25,000/mm3; <50.0-25.0 x 109/L.
Demonstrated acceptable safety profile by appropriate monitoring and management of adverse events
Grade ≥3 platelet count decreasea, and thrombocytopenia occurred in 13 patients (16.9%) and 2 patients (2.6%), respectively
➤ The median time to platelet count reduction to ≤50x109/L from the first dose was 15 days, and the median time to platelet count
recovery to ≥50x109/L was 12 days
6 patients (9.8%) experienced dose interruption or reduction due to platelet count decrease/thrombocytopenia, but no patients
discontinued treatment due to platelet count decrease/thrombocytopenia
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