Table 3 Summary of BOR per RECIST as per investigator assessment by treatment groups (full analysis set).

From: Pharmacokinetic–pharmacodynamic guided optimisation of dose and schedule of CGM097, an HDM2 inhibitor, in preclinical and clinical studies

 

10 mg Reg 1, N = 3

20 mg Reg 1, N = 4

40 mg Reg 1, N = 4

80 mg Reg 1, N = 4

150 mg Reg 1, N = 4

300 mg Reg 1, N = 7

400 mg Reg 1, N = 5

300 mg Reg 3, N = 8

500 mg Reg 3, N = 6

700 mg Reg 3, N = 6

All patients, N = 51

BOR

  CR

0

0

0

0

0

0

0

0

0

0

0

  PR

0

0

0

0

0

1 (14.3)

0

0

0

0

1 (2.0)

  SD

1 (33.3)

1 (25.0)

1 (25.0)

1 (25.0)

0

2 (28.6)

4 (80.0)

5 (62.5)

3 (50.0)

1 (16.7)

19 (37.3)

  PD

2 (66.7)

2 (50.0)

2 (50.0)

3 (75.0)

3 (75.0)

3 (42.9)

1 (20.0)

3 (37.5)

3 (50.0)

3 (50.0)

25 (49.0)

  Unknown

0

1 (25.0)

1 (25.0)

0

1 (25.0)

1 (14.3)

0

0

0

2 (33.3)

6 (11.8)

 ORR

0

0

0

0

0

1 (14.3)

0

0

0

0

1 (2.0)

  95% CI

[0.0, 70.8]

[0.0, 60.2]

[0.0, 60.2]

[0.0, 60.2]

[0.0, 60.2]

[0.4, 57.9]

[0.0, 52.2]

[0.0, 36.9]

[0.0, 45.9]

[0.0, 45.9]

[0.0, 10.4]

 DCR

1 (33.3)

1 (25.0)

1 (25.0)

1 (25.0)

0

3 (42.9)

4 (80.0)

5 (62.5)

3 (50.0)

1 (16.7)

2 (39.2)

  95% CI

[0.8, 90.6]

[0.6, 80.6]

[0.6, 80.6]

[0.6, 80.6]

[0.0, 60.2]

[9.9, 81.6]

[28.4, 99.5]

[24.5, 91.5]

[11.8, 88.2]

[0.4, 64.1]

[25.8, 53.9]

  1. BOR best overall response, CI confidence interval, DCR disease control rate, ORR overall response rate, PD progressive disease, PR partial response, Reg regimen.
  2. BOR was based on the investigator’s assessment of disease status using RECIST 1.1.
  3. CR and PR were confirmed by repeat assessments performed not less than 4 weeks after the criteria for the response was first met.
  4. The 95% CI was calculated using the exact (Clopper–Pearson) interval.
  5. Reg 1: 3qw dosing, 4-week treatment cycle, continuous; Reg 3: 3qw dosing, 3-week cycle; 2 weeks on treatment and 1 week off treatment.
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