Table 2 Tumour response per RECIST v1.1, progression-free survival and overall survival.

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

 

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)

ORR, n (%)

7 (30.4)

3 (13.0)

9 (47.4)

4 (20.0)

2 (8.7)

2 (10.0)

6 (28.6)

0 (0.0)

3 (30.0)

36 (20.0)

Best overall response, n (%)b

  CR

2 (8.7)

1 (4.3)

3 (15.8)

2 (10.0)

0 (0.0)

1 (5.0)

3 (14.3)

0 (0.0)

0 (0.0)

12 (6.7)

  PR

5 (21.7)

2 (8.7)

6 (31.6)

2 (10.0)

2 (8.7)

1 (5.0)

3 (14.3)

0 (0.0)

3 (30.0)

24 (13.3)

  SD

14 (60.9)

8 (34.8)

5 (26.3)

4 (20.0)

5 (21.7)

5 (25.0)

6 (28.6)

2 (9.5)

1 (10.0)

50 (27.8)

  Non-CR/ non-PD

0 (0.0)

0 (0.0)

0 (0.0)

7 (35.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

7 (3.9)

  PD

2 (8.7)

8 (34.8)

2 (10.5)

3 (15.0)

14 (60.9)

12 (60.0)

7 (33.3)

16 (76.2)

2 (20.0)

66 (36.7)

  NE

0 (0.0)

1 (4.3)

2 (10.5)

1 (5.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

4 (2.2)

  DCR, n (%)

21 (91.3)

11 (47.8)

14 (73.7)

15 (75.0)

7 (30.4)

7 (35.0)

12 (57.1)

2 (9.5)

4 (40.0)

93 (51.7)

  CBR, n (%)

15 (65.2)

7 (30.4)

11 (57.9)

10 (50.0)

4 (17.4)

4 (20.0)

8 (38.1)

1 (4.8)

3 (30.0)

63 (35.0)

  Median DoR, months (95% CI)

11.2 (6.2, NE)

6.2 (3.8, NE)

17.1 (3.0, NE)

NR (4.1, NE)

6.2 (4.3, 8.1)

NR (NE, NE)

NR (5.7, NE)

–

NR (22.4, NE)

17.1 (6.2, NE)

  Median PFS, months (95% CI)

8.2 (5.2, 11.8)

3.5 (1.9, 7.6)

8.4 (3.9, 19.0)

10.4 (4.3, 16.2)

2.0 (1.7, 2.3)

2.1 (1.9, 4.1)

3.5 (1.9, 7.5)

1.9 (1.1, 2.1)

2.2 (1.2, 24.4)

4.0 (2.2, 5.2)

  Median follow-up time for OS, months (95% CI)

27.4 (18.3, 29.0)

25.2 (12.5, 30.4)

18.7 (15.9, 21.4)

21.2 (19.1, 24.4)

29.4 (8.7, 29.4)

28.3 (19.3, 30.2)

23.3 (19.8, 26.0)

27.4 (NE, NE)

31.0 (30.3, 31.6)

23.3 (20.7, 25.6)

  Median OS, months (95% CI)

20.9 (13.5, NE)

18.7 (6.1, 27.0)

15.8 (10.4, NE)

21.2 (10.5, NE)

6.9 (3.3, 11.5)

7.4 (3.3, 13.4)

8.4 (4.4, 17.1)

4.1 (2.9, 5.0)

4.1 (1.2, 19.5)

10.4 (7.7, 14.2)

  1. Event-free rates for PFS and OS at various time points are reported in Supplementary Table S3. Tumour responses were assessed by investigators per RECIST v1.1. ORR was defined as the proportion of patients with a documented CR or PR. DCR was defined as the proportion of patients whose best overall response was CR, PR, or SD. CBR was defined as the proportion of patients who had a CR, PR, or SD of at least 24 weeks in duration. DoR was defined as the time from the first determination of an objective response, until the first documentation of progression or death, whichever occurred first. PFS was defined as the time between receiving the first dose of the study drug and the first determination of objectively documented tumour progression, or death, whichever occurred first. OS was defined as the time between receiving the first dose of the study drug and death due to any cause. For PFS and OS, medians were estimated by the Kaplan–Meier method with 95% CIs estimated using the method of Brookmeyer and Crowley. Data cutoff: 25 September 2020.
  2. BRCAmut breast cancer type 1/2 susceptibility gene mutation, BRCAwt breast cancer type 1/2 susceptibility gene wildtype, CBR clinical benefit rate, CI confidence interval, CR complete response, DCR disease control rate, DoR duration of response, 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, NE not estimable, NR not reached, ORR objective response rate, OS overall survival, PD progressive disease, PD-1 programmed cell death protein 1, PFS progression-free survival, PR partial response, RECIST v1.1 Response Evaluation Criteria in Solid Tumours version 1.1, SCLC small cell lung cancer, SD stable disease, TNBC triple-negative breast cancer.
  3. 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).
  4. bOf the 180 patients, 163 patients had both baseline and post-baseline tumour assessments.
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