Page 156 - Haematologica Vol. 109 - July 2024

ARTICLE - Sovleplenib Syk inhibitor in R/R B-cell tumors Y. Song et al. Table 2. Common treatment-emergent adverse events that related to study drug (any grade ≥20%) in the dose-escalation and
dose-expansion phases.
Dose-escalation phase, N (%)
200 mg q.d. N=7
400 mg q.d. N=3
600 mg q.d. N=6
800 mg q.d. N=3
200 mg b.i.d. N=8
Total N=27
Any grade
Grade ≥3
Any grade
Grade ≥3
Any grade
Grade ≥3
Any grade
Grade ≥3
Any grade
Grade ≥3
Any grade
Grade ≥3
At least one TEAE related to study drug
7 (100)
3 (42.9)
3 (100)
1 (33.3)
6 (100)
3 (50.0)
3 (100)
3 (100)
8 (100)
3 (37.5)
27 (100)
13 (48.1)
Aspartate aminotransferase increased
1 (14.3)
0
1 (33.3)
0
5 (83.3)
0
2 (66.7)
0
4 (50.0)
0
13 (48.1)
0
White blood cell count decreased
3 (42.9)
0
3 (100)
0
3 (50.0)
1 (16.7)
1 (33.3)
0
3 (37.5)
0
13 (48.1)
1 (3.7)
Neutrophil count decreased
3 (42.9)
1 (14.3)
2 (66.7)
0
3 (50.0)
3 (50.0)
1 (33.3)
1 (33.3)
3 (37.5)
0
12 (44.4)
5 (18.5)
Alanine aminotransferase increased
1 (14.3)
0
2 (66.7)
0
4 (66.7)
0
1 (33.3)
0
3 (37.5)
0
11 (40.7)
0
Yellow skin
3 (42.9)
0
1 (33.3)
0
3 (50.0)
0
1 (33.3)
0
2 (25.0)
0
10 (37.0)
0
Platelet count decreased
1 (14.3)
0
1 (33.3)
0
3 (50.0)
0
1 (33.3)
0
2 (25.0)
0
8 (29.6)
0
Proteinuria
1 (14.3)
0
0
0
3 (50.0)
0
0
0
3 (37.5)
0
7 (25.9)
0
Amylase increased
1 (14.3)
1 (14.3)
0
0
1 (16.7)
0
2 (66.7)
0
2 (25.0)
0
6 (22.2)
1 (3.7)
Anemia
2 (28.6)
1 (14.3)
0
0
1 (16.7)
0
0
0
3 (37.5)
0
6 (22.2)
1 (3.7)
Dose-expansion phase, N (%)
CLL/SLL N=19
Aggressive B-cell lymphomas N=14
MCL N=10
Indolent B-cell lymphoma N=64
Total N=107
Any grade
Grade ≥3
Any grade
Grade ≥3
Any grade
Grade ≥3
Any grade
Grade ≥3
Any grade
Grade ≥3
At least one TEAE related to study drug
-
19 (100)
15 (78.9)
12 (85.7)
8 (57.1)
10 (100)
4 (40.0)
64 (100)
45 (70.3)
105 (98.1)
72 (67.3)
Neutrophil count decreased
-
13 (68.4)
7 (36.8)
3 (21.4)
1 (7.1)
6 (60.0)
2 (20.0)
43 (67.2)
22 (34.4)
65 (60.7)
32 (29.9)
Aspartate aminotransferase increased
-
9 (47.4)
0
5 (35.7)
0
5 (50.0)
0
36 (56.3)
0
55 (51.4)
0
White blood cell count decreased
-
6 (31.6)
2 (10.5)
2 (14.3)
0
3 (30.0)
0
43 (67.2)
10 (15.6)
54 (50.5)
12 (11.2)
Alanine aminotransferase increased
-
6 (31.6)
1 (5.3)
4 (28.6)
0
5 (50.0)
0
33 (51.6)
0
48 (44.9)
1 (0.9)
Anemia
-
9 (47.4)
3 (15.8)
5 (35.7)
0
3 (30.0)
1 (10.0)
18 (28.1)
1 (1.6)
35 (32.7)
5 (4.7)
Platelet count decreased
-
10 (52.6)
3 (15.8)
2 (14.3)
0
4 (40.0)
2 (20.0)
18 (28.1)
5 (7.8)
34 (31.8)
10 (9.3)
b.i.d.: twice daily; q.d.: once daily; CLL: chronic lymphocytic leukemia; MCL: mantle cell lymphoma; SLL: small lymphocytic lymphoma; TEAE: treatment-emergent adverse event.
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