Table 4 Incidence of the most common any grade 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)

TEAEs occurring in ≥15% of patients in the overall population by preferred term, n (%)

  Nausea

18 (78.3)

17 (73.9)

15 (78.9)

8 (40.0)

8 (34.8)

7 (35.0)

12 (57.1)

13 (61.9)

3 (30.0)

101 (56.1)

  Fatigue

10 (43.5)

15 (65.2)

12 (63.2)

13 (65.0)

5 (21.7)

11 (55.0)

9 (42.9)

9 (42.9)

5 (50.0)

89 (49.4)

  Diarrhoea

10 (43.5)

6 (26.1)

8 (42.1)

4 (20.0)

4 (17.4)

6 (30.0)

6 (28.6)

3 (14.3)

1 (10.0)

48 (26.7)

  Constipation

4 (17.4)

8 (34.8)

5 (26.3)

6 (30.0)

3 (13.0)

8 (40.0)

3 (14.3)

6 (28.6)

2 (20.0)

45 (25.0)

  Anaemia

5 (21.7)

2 (8.7)

11 (57.9)

5 (25.0)

3 (13.0)

2 (10.0)

5 (23.8)

5 (23.8)

2 (20.0)

40 (22.2)

  Back pain

8 (34.8)

4 (17.4)

5 (26.3)

5 (25.0)

5 (21.7)

5 (25.0)

3 (14.3)

3 (14.3)

0 (0.0)

38 (21.1)

  Vomiting

6 (26.1)

5 (21.7)

8 (42.1)

3 (15.0)

2 (8.7)

4 (20.0)

4 (19.0)

3 (14.3)

2 (20.0)

37 (20.6)

  Decreased appetite

6 (26.1)

4 (17.4)

2 (10.5)

2 (10.0)

8 (34.8)

3 (15.0)

3 (14.3)

5 (23.8)

2 (20.0)

35 (19.4)

  Aspartate aminotransferase increased

3 (13.0)

4 (17.4)

3 (15.8)

3 (15.0)

2 (8.7)

2 (10.0)

9 (42.9)

2 (9.5)

2 (20.0)

30 (16.7)

  Alanine aminotransferase increased

4 (17.4)

4 (17.4)

3 (15.8)

3 (15.0)

2 (8.7)

2 (10.0)

8 (38.1)

1 (4.8)

2 (20.0)

29 (16.1)

  Headache

5 (21.7)

3 (13.0)

5 (26.3)

3 (15.0)

3 (13.0)

3 (15.0)

2 (9.5)

2 (9.5)

1 (10.0)

27 (15.0)

  1. All adverse events were coded using MedDRA version 22.0.
  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, 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).
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