Table 2 Summary of TRAEs

From: SEZ6-targeting antibody−drug conjugate ABBV-706 in advanced small cell lung cancer and solid tumors: a phase 1 trial

a. All monotherapy

 

1.3 mg kg−1

n = 10

1.8 mg kg−1

n = 71

2.5 mg kg−1

n = 139

3.0 mg kg−1

n = 15

3.5 mg kg−1

n = 5

Total

N = 240

Any grade

Grade ≥3

Any grade

Grade ≥3

Any grade

Grade ≥3

Any grade

Grade ≥3

Any grade

Grade ≥3

Any grade

Grade ≥3

Any TRAE, n (%)

8 (80)

4 (40)

63 (89)

28 (40)

131 (94)

97 (70)

15 (100)

13 (87)

5 (100)

5 (100)

222 (93)

147 (61)

TRAE leading to ABBV-706 discontinuation, n (%)

1 (10)

5 (7)

9 (7)

1 (7)

0

16 (7)

TRAE leading to dose interruption, n (%)

1 (10)

17 (24)

71 (51)

9 (60)

4 (80)

102 (43)

TRAE leading to dose reduction, n (%)

1 (10)

11 (16)

46 (33)

11 (73)

4 (80)

73 (30)

TRAE leading to death, n (%)

0

3 (4)

0

0

0

3 (1)

SAE related to ABBV-706, n (%)

1 (10)

9 (13)

18 (13)

1 (7)

1 (20)

30 (13)

Hematologic TRAEs occurring with an incidence of ≥20% (with combined terms)

 Anemia

1 (10)

1 (10)

36 (51)

22 (31)

93 (67)

73 (53)

12 (80)

7 (47)

5 (100)

5 (100)

147 (61)

108 (45)

 Red blood cell count decreased

0

0

1 (1)

0

0

0

0

0

0

0

1 (1)

0

 Neutropenia

0

0

2 (2.8)

1 (1)

21 (15)

13 (9)

0

0

0

0

23 (10)

14 (6)

 Neutrophil count decreased

0

0

20 (28)

10 (14)

54 (39)

44 (32)

11 (73)

11 (73)

5 (100)

4 (80)

90 (38)

69 (29)

 Thrombocytopenia

0

0

2 (2.8)

0

16 (12)

4 (3)

1 (7)

1 (7)

0

0

19 (8)

5 (2)

 Platelet count decreased

1 (10)

1 (1)

14 (20)

8 (11)

41 (30)

27 (19)

9 (60)

6 (40)

4 (80)

3 (60)

69 (29)

45 (19)

 Leukopenia

0

0

1 (1)

0

2 (1)

0

0

0

0

0

3 (1)

0

 White blood cell decreased

1 (10)

1 (10)

15 (21)

4 (6)

34 (25)

29 (21)

9 (60)

7 (47)

4 (80)

4 (80)

63 (26)

45 (19)

Non-hematologic TRAEs occurring with an incidence of ≥20%

 Fatigue

5 (50)

1 (10)

26 (37)

1 (1)

47 (34)

7 (5)

10 (67)

0

3 (60)

0

91 (38)

9 (4)

 Nausea

5 (50)

0

27 (38)

0

51 (37)

2 (1)

3 (20)

0

0

0

86 (36)

2 (1)

 Decreased appetite

4 (40)

0

12 (17)

1 (1)

32 (23)

2 (1)

1 (7)

0

1 (20)

0

50 (21)

3 (1)

b. R/R SCLC monotherapy

 

1.8 mg kg−1

(n = 41)

2.5 mg kg−1

(n = 39)

Part 1 + 2a + 2c

(n = 124)

Any TRAE, n (%)

36 (88)

38 (97)

115 (93)

 Grade ≥3

22 (54)

30 (77)

75 (61)

TRAE leading to ABBV-706 discontinuation, n (%)

5 (12)

3 (8)

10 (8)

TRAE leading to dose interruption, n (%)

13 (32)

25 (64)

55 (44)

TRAE leading to dose reduction, n (%)

8 (20)

13 (33)

34 (27)

TRAE leading to death, n (%)

3 (7)

0

3 (2)

SAEs, n (%)

7 (17)

6 (15)

18 (15)

Hematologic TRAEs occurring with an incidence of ≥20% in full monotherapy cohort

 

Any grade

Grade ≥3

Any grade

Grade ≥3

Any grade

Grade ≥3

 Anemia

22 (54)

17 (42)

29 (74)

25 (64)

79 (64)

57 (46)

 Red blood cell decreased

0

0

0

0

1 (1)

0

 Neutropenia

1 (2)

0

3 (8)

1 (3)

5 (4)

2 (2)

 Neutrophil count decreased

13 (32)

8 (20)

17 (44)

12 (31)

49 (40)

32 (26)

 Thrombocytopenia

1 (2)

0

5 (13)

2 (5)

7 (6)

2 (2)

 Platelet count decreased

9 (22)

6 (15)

15 (39)

9 (23)

41 (33)

27 (22)

 Leukopenia

0

0

1 (3)

0

2 (2)

0

 White blood cell decreased

8 (20)

3 (7)

9 (23)

8 (21)

31 (25)

17 (14)

Non-hematologic TRAEs occurring with an incidence of ≥20% in full monotherapy cohort

 

Any grade

Grade ≥3

Any grade

Grade ≥3

Any grade

Grade ≥3

 Fatigue

14 (34)

1 (2)

14 (36)

2 (5)

47 (38)

4 (3)

 Nausea

15 (37)

0

10 (26)

1 (3)

40 (32)

1 (1)

 Decreased appetite

8 (20)

1 (2)

16 (41)

1 (3)

34 (27)

2 (2)

  1. a,b, TRAEs in all monotherapy patients (a) and patients with R/R SCLC, including those in the 1.8 mg kg−1 and 2.5 mg kg−1 dose-optimization cohorts (b).
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