Table 2 Efficacy results-FAS

From: Fruquintinib plus sintilimab in patients with advanced endometrial cancer with mismatch-repair proficient status: a multicenter, single-arm, phase Ib/II trial

 

Patients with pMMR

 

Pivotal population

Total pMMR population

 

IRC assessment N = 76

Investigator assessment N = 76

IRC assessment N = 98

Investigator assessment N = 98

Best overall response, n (%)

    

 CR

3 (3.9)

1 (1.3)

4 (4.1)

1 (1.0)

 PR

21 (27.6)

22 (28.9)

28 (28.6)

31 (31.6)

 SD

38 (50.0)

40 (52.6)

47 (48.0)

51 (52.0)

 Non-CR/non-PD

1 (1.3)

0

3 (3.1)

0

 PD

10 (13.2)

10 (13.2)

12 (12.2)

11 (11.2)

 Not evaluable

3 (3.9)

3 (3.9)

4 (4.1)

4 (4.1)

ORRa, %

(95% CI)

31.6 (21.4–43.3)

30.3

(20.2–41.9)

32.7

(23.5–42.9)

32.7

(23.5–42.9)

DCR, %

(95% CI)

82.9

(72.5–90.6)

82.9

(72.5–90.6)

83.7

(74.8–90.4)

84.7

(76.0–91.2)

Median DoR, months

(95% CI)

17.9

(11.1–NE)

12.0

(6.9–15.2)

20.5

(11.1–NE)

12.0

(6.9–15.2)

 Event (PD or death)b, n (%)

8 (33.3)

13 (56.5)

11 (34.4)

17 (53.1)

 9-month DoR rate, %

(95% CI)

83.2

(56.4–94.3)

72.4

(48.6–86.6)

78.4

(55.5–90.4)

64.1

(43.5–78.9)

Median TTR, months

(95% CI)

1.9

(1.4–4.2)

2.2

(1.4–2.7)

1.9

(1.4–4.0)

2.4

(1.4–2.8)

  1. aConfirmed ORR.
  2. bDenominator was number of patients with confirmed objective response (CR or PR).
  3. CI confidence interval, CR complete response, DCR disease control rate, DoR duration of response, FAS full analysis set, IRC independent review committee, NE not estimable, ORR objective response rate, PD progressive disease, PR partial response, SD stable disease, TTR time to response.
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