Table 3 Summary of incidence of treatment-emergent adverse events.

From: Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-expansion stage of a multicentre, open-label, phase I trial

n (%)

EOC BRCAmut and/or HRD (Arm 1a; n = 23)

EOC

BRCAwt and HRP (Arm 1b; n = 23)

TNBC BRCAmut and/or HRD (Arm 2; n = 19)

mCRPC BRCAmut and/or HRD (Arm 3; n = 20)

SCLC (Arm 4; n = 23)

HER2− G/GEJ cancer (Arm 5; n = 20)

Urothelial cancer (Arm 6; n = 21)

Pancreatic cancer (Arm 7; n = 21)

Exploratory arma (Arm 8; n = 10)

Total (N = 180)

Any TEAE

23 (100.0)

23 (100.0)

19 (100.0)

20 (100.0)

23 (100.0)

20 (100.0)

21 (100.0)

21 (100.0)

9 (90.0)

179 (99.4)

≥Grade 3 TEAEs

12 (52.2)

19 (82.6)

8 (42.1)

11 (55.0)

14 (60.9)

14 (70.0)

15 (71.4)

10 (47.6)

8 (80.0)

111 (61.7)

Serious TEAEs

6 (26.1)

16 (69.6)

7 (36.8)

8 (40.0)

14 (60.9)

10 (50.0)

13 (61.9)

8 (38.1)

8 (80.0)

90 (50.0)

Related to either pamiparib or tislelizumab

4 (17.4)

6 (26.1)

2 (10.5)

3 (15.0)

3 (13.0)

4 (20.0)

5 (23.8)

0 (0.0)

2 (20.0)

29 (16.1)

TEAEs leading to death

0 (0.0)

0 (0.0)

0 (0.0)

1 (5.0)

4 (17.4)

0 (0.0)

2 (9.5)

0 (0.0)

1 (10.0)

8 (4.4)

TEAEs leading to discontinuation of pamiparib

5 (21.7)

5 (21.7)

1 (5.3)

0 (0.0)

2 (8.7)

2 (10.0)

7 (33.3)

4 (19.0)

1 (10.0)

27 (15.0)

TEAEs leading to discontinuation of tislelizumab

5 (21.7)

5 (21.7)

1 (5.3)

2 (10.0)

3 (13.0)

3 (15.0)

6 (28.6)

1 (4.8)

1 (10.0)

27 (15.0)

TEAEs leading to discontinuation of both pamiparib and tislelizumab

1 (4.3)

2 (8.7)

0 (0.0)

0 (0.0)

2 (8.7)

1 (5.0)

5 (23.8)

1 (4.8)

1 (10.0)

13 (7.2)

TEAEs leading to reduction of pamiparib dose

2 (8.7)

1 (4.3)

3 (15.8)

0 (0.0)

0 (0.0)

2 (10.0)

0 (0.0)

1 (4.8)

1 (10.0)

10 (5.6)

TEAEs related to either pamiparib or tislelizumab

22 (95.7)

22 (95.7)

17 (89.5)

17 (85.0)

18 (78.3)

15 (75.0)

19 (90.5)

13 (61.9)

5 (50.0)

148 (82.2)

Related to pamiparib

20 (87.0)

22 (95.7)

17 (89.5)

15 (75.0)

18 (78.3)

15 (75.0)

16 (76.2)

13 (61.9)

3 (30.0)

139 (77.2)

Related to tislelizumab

18 (78.3)

18 (78.3)

16 (84.2)

16 (80.0)

15 (65.2)

14 (70.0)

16 (76.2)

13 (61.9)

3 (30.0)

129 (71.7)

Related to pamiparib and tislelizumab

14 (60.9)

17 (73.9)

15 (78.9)

11 (55.0)

10 (43.5)

14 (70.0)

13 (61.9)

13 (61.9)

1 (10.0)

108 (60.0)

Immune-mediated TEAEs

7 (30.4)

6 (26.1)

3 (15.8)

4 (20.0)

4 (17.4)

2 (10.0)

3 (14.3)

0 (0.0)

2 (20.0)

31 (17.2)

Hepatic TEAEb

8 (34.8)

7 (30.4)

6 (31.6)

3 (15.0)

5 (21.7)

3 (15.0)

10 (47.6)

2 (9.5)

2 (20.0)

46 (25.6)

≥Grade 3 hepatic TEAEs as the first hepatic TEAE

4 (17.4)

4 (17.4)

0 (0.0)

0 (0.0)

2 (8.7)

2 (10.0)

3 (14.3)

0 (0.0)

0 (0.0)

15 (8.3)

  1. All adverse events were coded using MedDRA version 22.0 and graded according to the NCI CTCAE v4.03.
  2. Data cutoff: 25 September 2020.
  3. BRCAmut breast cancer type 1/2 susceptibility gene mutation, BRCAwt breast cancer type 1/2 susceptibility gene wildtype, EOC epithelial ovarian cancer, G/GEJ gastric or gastroesophageal junction, HER2− HER2 negative, HRD homologous recombination deficiency, HRP homologous recombination proficiency, mCRPC metastatic castration-resistant prostate cancer, MedDRA Medical Dictionary for Regulatory Activities, NCI CTCAE National Cancer Institute’s Common Terminology Criteria for Adverse Events, PD-1 programmed cell death protein 1, SCLC small cell lung cancer, TEAE treatment-emergent adverse event, TNBC triple-negative breast cancer.
  4. aPatients with non-ovarian gynaecological cancers (endometrial cancer or cancer of the cervix) and patients with tumours known to be mismatch repair deficient or HRD that are not eligible for inclusion in any other arms of the trial but that may be expected to benefit from the PARP/PD-1 inhibitor combination (see Supplementary Table S1 for the full list of cancer types enrolled in this arm).
  5. bIncidence of hepatic TEAEs is reported as defined by the MedDRA according to laboratory terms (alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, transaminases increased) or non-laboratory terms (hepatitis, immune-mediated hepatitis, autoimmune hepatitis, hepatic failure). If a patient experienced multiple hepatic TEAEs, only the first hepatic TEAE was counted.
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