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Table 3 Efficacy outcomes by tumor type

From: A phase 1 trial of fuzuloparib in combination with apatinib for advanced ovarian and triple-negative breast cancer: efficacy, safety, pharmacokinetics and germline BRCA mutation analysis

 

Platinum-sensitive OC (n = 10)

Platinum-resistant OC (n = 17)

TNBC (n = 22)

Total (n = 52)a

Best overall response per RECIST v1.1, n (%)

 CR

4 (40.0%)

1 (5.9%)

0

5 (9.6%)

 PR

4 (40.0%)

5 (29.4%)

5 (22.7%)

14 (26.9%)

 SD

1 (10.0%)

7 (41.2%)

7 (31.8%)

15 (28.8%)

 PD

1 (10.0%)

4 (23.5%)

9 (40.9%)

17 (32.7%)

 NE

0

0

1 (4.5%)

1 (1.9%)

Confirmed ORR, % (95% CI)

80.0 (44.4–97.5)

35.3 (14.2–61.7)

22.7 (7.8–45.4)

36.5 (23.6–51.0)

DCR, % (95% CI)

90.0 (55.5–99.7)

76.5 (50.1–93.2)

54.5 (32.2–75.6)

65.4 (50.9–78.0)

Median DoR (95% CI), months

9.3 (7.4-NR)

18.4 (12.0-NR)

4.5 (3.7-NR)

11.1 (7.4–16.6)

CA-125 response, % (95% CI)b

100 (47.8–100)

42.9 (17.7–71.1)

-

50.0 (28.2–71.8)

Median PFS (95% CI), months

12.1 (1.9-NR)

5.8 (2.1–18.5)

3.8 (2.0–5.7)

5.7 (3.5–6.7)

Median OS (95% CI), months

NR (20.4-NR)

25.5 (14.9-NR)

10.7 (7.5-NR)

21.1 (14.9–33.9)

  1. aIncluded 3 patients with platinum-refractory OC. bAssessed in 22 patients with OC (5 platinum-sensitive and 17 platinum-resistant) who had CA-125 level above 2 folds of the normal upper limit at baseline. CR Complete response, DCR Disease control rate, DoR Duration of response, NE Not evaluable, NR Not reached, OC Ovarian cancer, ORR Objective response rate, OS Overall survival, PFS Progression-free survival, PR Partial response, PD Progressive disease, RECIST Response evaluation criteria in solid tumors, SD Stable disease, TNBC Triple-negative breast cancer