Table 2 Treatment response and survival outcomes of the overall population-ITT

From: Novel CDK2/4/6 inhibitor culmerciclib (TQB3616) plus fulvestrant in previously treated, HR-positive, HER2-negative advanced breast cancer: a randomized, double-blind, phase 3 trial

 

Culmerciclib plus fulvestrant N = 194

Placebo plus fulvestrant N = 99

P

Duration of follow-up, median (95% CI), months

13.8 (11.1, 13.8)

13.8 (11.2, 16.4)

 

PFS assessed by investigators

 Median (95% CI), months

16.6 (13.8, NE)

7.5 (5.3, 11.0)

<0.001a

 HR (95% CI)b

0.36 (0.26, 0.51)

 

 6-month PFS rate, % (95% CI)

82.7 (76.3, 87.5)

51.5 (41.1, 60.9)

 

 12-month PFS rate, % (95% CI)

65.9 (57.8, 72.7)

32.8 (23.1, 42.8)

 

 18-month PFS rate, % (95% CI)

44.4 (30.2, 57.6)

NE (NE, NE)

 

PFS assessed by independent radiological committee

 Median (95% CI), months

NE (16.6, NE)

10.4 (7.4, NE)

 

 HR (95% CI)

0.42 (0.28, 0.62)

<0.001a

Objective response assessed by investigatorsc

 % (95% CI)c

40.2 (33.3, 47.5)

12.1 (6.4, 20.2)

 

 Odds ratio (95% CI)f

5.28 (2.66,10.47)

<0.001h

Best overall response, n (%)

 Complete response

5 (2.6)

0 (0.0)

 

 Partial response

73 (37.6)

12 (12.1)

 

 Stable disease

96 (49.5)

60 (60.6)

 

 Progressive disease

13 (6.7)

26 (26.3)

 

 Not evaluabled

0 (0.0)

0 (0.0)

 

 No assessmente

7 (3.6)

1 (1.0)

 

Objective response among patients with a measurable lesion at baseline assessed by investigatorsc

 % (95% CI)g

46.4(38.7, 54.3)

14.1 (7.5, 23.4)

 

 Odds ratio (95% CI)f

5.46 (2.74, 10.86)

<0.0001h

Best overall response, n (%)

 Complete response

5 (3.0)

0 (0.0)

 

 Partial response

73 (43.5)

12 (14.1)

 

 Stable disease

76 (45.2)

49 (57.7)

 

 Progressive disease

10 (6.0)

23 (27.1)

 

 Not evaluabled

0 (0.0)

0 (0.0)

 

 No assessmente

4 (2.4)

1 (1.2)

 

 Duration of response assessed by investigators, median (95% CI), months

14.8 (12.0, NE)

NE (5.7, NE)

 

 HR (95% CI)a

1.55 (0.35, 6.83)

0.563b

Disease control assessed by investigatorsc

 % (95% CI)

89.7 (84.5, 93.6)

72.7 (62.9, 81.2)

 

 Odds ratio (95% CI)f

3.30 (1.73,6.29)

<0.001h

Clinical benefit assessed by investigatorsc

 % (95% CI)g

76.3 (69.7, 82.1)

50.5 (40.3, 60.7)

 

 Odds ratio (95% CI)f

3.17 (1.89, 5.31)

<0.001h

Overall survival (OS), months

 % (95% CI)

NE (NE, NE)

NE (NE, NE)

 

 HR (95% CI)a

0.67 (0.36, 1.22)

0.188b

 6-month OS rate, % (95% CI)

97.4 (93.8, 98.9)

99.0 (93.1, 99.9)

 

 12-month OS rate, % (95% CI)

89.5 (84.1, 93.2)

87.7 (78.8, 93.0)

 

 18-month OS rate, % (95% CI)

79.0 (66.4, 87.3)

73.9 (60.5, 83.3)

 
  1. BIRC blinded independent radiological committee, CI confidence interval, DCR disease control rate, HR hazard ratio, NE not evaluable, ORR objective response rate, OS overall survival, PFS progression-free survival
  2. aStratified log rank test
  3. bStratified Cox proportional-hazards model. Stratifications factors include visceral metastatic disease (yes vs. no), menopausal status (pre-, peri- or postmenopausal), and sensitivity to prior endocrine therapy (yes vs. no)
  4. cAn objective response is defined as a complete response or a partial response and disease control is defined as a complete response, a partial response or a stable disease. Clinical benefit rate is the proportion of patients with an objective response [complete or partial] or stable disease as their best overall response lasting ≥24 weeks
  5. dPatients had at least one postbaseline radiological evaluation but were not evaluable per RECIST, version 1.1 or other criteria, or less than 6 weeks had elapsed between randomization and complete response, partial response or stable disease
  6. ePatients had no postbaseline radiological evaluation
  7. fOR was estimated by logistic regression
  8. gThe confidence interval was calculated using exact binomial method
  9. hStratified Mantel-Haenszel χ2 test with stratification according to visceral metastatic disease (yes vs. no), menopausal status (pre-, peri- or postmenopausal), and sensitivity to prior endocrine therapy (yes vs. no)
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