TABLE 2.
Efficacy Results by IRC Assessment
| Outcome | Previous Platinum Chemotherapy (n = 247) | Treatment-Naïve (n = 69) |
|---|---|---|
| ORRa | ||
| No. (%) | 152 (61.5) | 57 (82.6) |
| 95% CI | 55.2 to 67.6 | 71.6 to 90.7 |
| Best overall response, No. (%) | ||
| Complete response | 20 (8.1) | 5 (7.2) |
| Partial response | 132 (53.4) | 52 (75.4) |
| Stable disease | 80 (32.4) | 7 (10.1) |
| Progressive disease | 7 (2.8) | 3 (4.3) |
| Not evaluable | 8 (3.2) | 2 (2.9) |
| Time to response, months | ||
| Median (range) | 1.9 (0.7-44.2) | 1.8 (0.7-10.8) |
| DoRb | ||
| Patients with a response, No. | 152 | 57 |
| Patients with censored data, No. (%) | 75 (49.3) | 25 (43.9) |
| DoR, months, median (95% CI) | 31.6 (20.4 to 42.3) | 20.3 (15.4 to 29.5) |
| Duration of follow-up, months, median (Q1-Q3) | 39.5 (24.6-45.0) | 37.1 (24.0-45.1) |
| 1-year DoR, % (95% CI) | 73.0 (65.0 to 79.5) | 66.7 (52.4 to 77.6) |
| 2-year DoR, % (95% CI) | 55.1 (46.4 to 62.9) | 38.1 (24.5 to 51.6) |
| 3-year DoR, % (95% CI) | 44.7 (35.7 to 53.4) | 35.4 (22.0 to 49.0) |
| PFS | ||
| Patients with censored data, No. (%) | 114 (46.2) | 31 (44.9) |
| PFS, months, median (95% CI) | 26.2 (19.3 to 35.7) | 22.0 (16.5 to 24.9) |
| Duration of follow-up, months, median (Q1-Q3) | 41.2 (24.9-46.9) | 38.9 (19.4-46.9) |
| 1-year PFS, % (95% CI) | 70.6 (64.2 to 76.1) | 70.8 (58.0 to 80.3) |
| 2-year PFS, % (95% CI) | 52.3 (45.4 to 58.7) | 44.9 (31.8 to 57.3) |
| 3-year PFS, % (95% CI) | 41.1 (34.2 to 47.9) | 34.6 (22.3 to 47.3) |
| OS | ||
| Patients with censored data, No. (%) | 137 (55.5) | 43 (62.3) |
| OS, months, median (95% CI) | 47.6 (35.9 to NE) | NE (37.8 to NE) |
| Duration of follow-up, months, median (Q1-Q3) | 44.6 (37.6-49.8) | 41.9 (34.3-47.6) |
| 1-year OS, % (95% CI) | 87.9 (83.1 to 91.5) | 94.1 (85.1 to 97.8) |
| 2-year OS, % (95% CI) | 67.9 (61.5 to 73.5) | 74.3 (61.9 to 83.1) |
| 3-year OS, % (95% CI) | 56.6 (49.8 to 62.8) | 65.6 (52.4 to 75.9) |
Abbreviations: DoR, duration of response; IRC, independent review committee; NE, not evaluable; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q1, first quartile; Q3, third quartile.
a
ORR was defined as the proportion of patients with best overall response of confirmed complete response or partial response. Response was confirmed by a repeat assessment ≥28 days.
b
Censored patients are represented as a percentage of responders by IRC assessment, treatment-naïve (n = 57) and pretreated patients (n = 152).