Table 3 Summary of response rates
Module 1A (evaluable for anti-tumor activity analysis population) N = 36 | |
Disease control rate, n (%) | 19 (52.8) |
Objective response rate, n (%) | 1 (3.2) |
Best objective response, n (%) | |
Complete response | 0 |
Partial response | 1 (2.8) |
Stable disease | 18 (50.0) |
Progressive disease | 17 (47.2) |
Module 1B-1 (evaluable for response population) N = 20 | |
Clinical benefit rate at 24 weeks, n (%) | 5 (25.0) |
Objective response rate, n (%) | 1 (5.0) |
Best objective response, n (%) | |
Complete response | 0 |
Partial response | 1 (5.0) |
Stable disease | 11 (55.0) |
Progressive disease | 8 (40.0) |
Progression-free survival (months) (Intent-to-Treat Population) N = 23 | |
Median (95% confidence interval) | 2.4 (1.9, 3.8) |
Module 2A (evaluable for response population) N = 25 | |
Clinical benefit rate at 24 weeks, n (%) | 9 (36.0) |
Objective response rate, n (%) | 3 (12.0) |
Best objective response, n (%) | |
Complete response | 0 |
Partial response | 3 (12.0) |
Stable disease | 13 (52.0) |
Progressive disease | 9 (36.0) |
Clinical benefit rate at 24 weeks by subgroup, n (%) | |
No liver metastases (N = 11) | 6 (54.5) |
Liver metastases (N = 14) | 3 (21.4) |
No TP53 mutation (N = 19) | 9 (47.4) |
TP53 mutation (N = 6) | 0 |
Progression-free survival (months) (intent-to-treat population) N = 31 | |
Median (95% confidence interval) | 3.7 (1.8, 7.4) |
No liver metastases (N = 17) | 13.8 (7.4, NC) |
Liver metastases (N = 14) | 2.8 (1.8, 7.4) |
No TP53 mutation (N = 20) | 7.4 (3.7, NC) |
TP53 mutation (N = 7) | 1.8 (1.7, NC) |
