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) | 11.1 (1.7, NC) |
| Liver metastases (N = 14) | 2.8 (1.8, 5.3) |
| No TP53 mutation (N = 20) | 7.4 (3.7, NC) |
| TP53 mutation (N = 7) | 1.8 (1.7, NC) |
Disease control rate defined as percentage of patients with a complete response (CR) or partial response (PR) or stabilization of disease at first on-treatment RECIST assessment. Objective response rate defined as the percentage of patients who had at least 1 objective response (CR or PR) prior to any evidence of progression. Clinical benefit rate defined as the percentage of patients with CR or PR or stabilization of disease for at least 24 weeks between enrollment and disease progression or death due to any cause. RECIST V1.1 endpoints were assessed in the response evaluable population - defined as all patients who received ≥1 dose of samuraciclib and had a post-baseline tumor assessment. Statistical analyses of progression-free survival using the Kaplan–Meier method were performed on the intent-to-treat population.
NC not calculated.