Table 4.
Efficacy
| Population | Intent-to-Treat (N = 39) | Efficacy Evaluable (N = 36) | ||
|---|---|---|---|---|
| n (%) | 95% CI | n (%) | 95% CI | |
| Objective Response | 10 (25.6) | 13.0-42.1 | 10 (27.8) | 14.2-45.2 |
| CR | 1 (2.6) | 0.1-13.5 | 1 (2.8) | 0.1-14.5 |
| PR | 9 (23.1) | 11.1-39.3 | 9 (25.0) | 12.1-42.2 |
| SD | 20 (51.3) | 34.8-67.6 | 19 (52.8) | 35.5-69.6 |
| PD | 8 (20.5) | 9.3-36.5 | 7 (19.4) | 8.2-36.0 |
| NE* | 1 (2.6) | ---- | 0 | 0 |
| DSR | 30 (76.9) | 60.7-88.9 | 29 (80.6) | 64.0-91.8 |
| Patients having SD ≥ 3 months | 19 (48.7) | 19 (52.8) | ||
| Objective Response by RECIST by Platinum Status (ITT) |
Platinum Refractory or Primary Platinum Resistant N = 15 n (%); [95% CI] |
Secondary Platinum Resistant N = 24 n (%); [95% CI] |
||
| ORR | 4 (26.7); [7.8-55.1] | 6 (25.0); [9.8-46.7] | ||
| CR | 1 (6.7); [0.2-31.9] | 0 | ||
| PR | 3 (20.0); [4.3-48.1] | 6 (25.0); [9.8-46.7] | ||
| SD | 8 (53.3); [26.6-78.7] | 12 (50.0); [29.1-70.9] | ||
| PD | 3 (20.0); [4.3-48.1] | 5 (20.8); [7.1-42.2] | ||
| NE | 0 | 1 (4.2); NA | ||
| Patients having SD ≥ 3 Months | 7 (46.7) | 12 (50.0) | ||
|
ITT Population n; Median |
ITT Population Q1-Q3 |
|||
| Duration of Response (Months) | 10; 9.7 | 5.8-NA | ||
| CR | 1; NA | NA | ||
| PR | 9; 9.7 | 5.8-NA | ||
| Duration of SD | 20; 6.4 | 4.3-13.9 | ||
| Time to Objective Response | 10; 2.9 | 2.3-3.9 | ||
|
Platinum Refractory or Primary Platinum Resistant N = 15 |
Secondary Platinum Resistant N = 24 |
All N = 39 |
||
| Median (Q1-Q3) | Median (Q1-Q3) | Median (Q1-Q3) | ||
| Time to Tumor Progression (Months) | 6.4 (4.1-14.0) | 6.0 (2.6-12.0) | 6.2 (3.3-12.0) | |
| Progression-free Survival (Months) | 6.4 (4.1-14.0) | 5.8 (2.3-11.6) | 6.0 (2.6-12.0) | |
| Overall Survival (Months) | 17.8 (7.0-NA) | 17.4 (8.1-NA) | 17.8 (7.7-NA) | |
Abbreviations: NE, not evaluable; CI, confidence interval