Table 2.
Efficacy (RECIST 1.1 and clinical progression) per investigator assessment in ITT patients, by platinum status
| Platinum-resistant relapse N = 41 |
Platinum-sensitive relapse N = 33 |
|
|---|---|---|
| Non-progression rate (%), median [90% CI] | 3 months | 6 months |
| All patients | 69.8 [55.9–80.0] | 43.8 [29.0–57.4] |
| BRCA1/2mut | N = 4 | N = 11 |
| 50.0 [10.3–80.9] | 40.0 [15.9–63.3] | |
| BRCA1/2wt / missing status | N = 37 | N = 22 |
| 72.2 [57.8–82.4] | 45.5 [27.7–61.6] | |
| Best overall response (confirmed)* | ||
| Complete response | 0 | 1 (3%) |
| Partial response | 11 (28%) | 11 (34%) |
| Stable disease | 18 (46%) | 16 (50%) |
| Progressive disease | 10 (26%) | 4 (13%) |
| Not evaluable | 2 | 1 |
| Objective response rate (%) [95% CI]* | 11 (28%) [15–45] | 12 (38%) [21–56] |
| Median PFS, in months [95% CI] | 4.1 [3.5−5.9] | 4.9 [2.9−7.0] |
| Median OS, in months [95% CI] | 18.8 [9.6 - NR] | 18.5 [15.6 - NR] |
NR not reached
*In evaluable patients