Table 2 Objective response summary

From: Sacituzumab govitecan in HR+HER2 metastatic breast cancer: the randomized phase 3 EVER-132-002 trial

 

BICR-assessed

INV-assessed

SG (n = 166)

Chemotherapy (n = 165)

SG (n = 166)

Chemotherapy (n = 165)

ORR, n (%)

34 (20)

25 (15)

31 (19)

26 (16)

 95% CI

(15 to 27)

(10 to 22)

(13 to 25)

(11 to 22)

 Odds ratio (95% CI)

1.46 (0.82 to 2.61)

1.24 (0.69 to 2.22)

P value

0.1994

0.4742

CR

2 (1)

0

0

0

PR

32 (19)

25 (15)

31 (19)

26 (16)

SD

93 (56)

82 (50)

103 (62)

89 (54)

PD

36 (22)

45 (27)

29 (17)

39 (24)

Not evaluable

3 (2)

13 (8)

3 (2)

11 (7)

CBR, n (%)

63 (38)

37 (22)

77 (46)

48 (29)

 95% CI

(31 to 46)

(16 to 30)

(39 to 54)

(22 to 37)

 Odds ratio (95% CI)

2.17 (1.33 to 3.55)

2.11 (1.34 to 3.33)

P value

0.0018

0.0012

Median DoR,a months (95% CI)

5.3 (4.1 to 9.8)

5.2 (4.2 to 9.7)

8.2 (5.7 to 9.4)

4.2 (2.9 to 5.6)

  1. aIn patients with confirmed objective response with SG (BICR-assessed, n = 34; INV-assessed, n = 31) and chemotherapy (BICR-assessed, n = 25; INV-assessed, n = 26).