Table 2.
Summary of Efficacy (ITT Population)
| Objective Tumor Responsea | ||||
|---|---|---|---|---|
| PCb | PC | |||
| Parameter | All N=46 |
Nonsquamous N=33 |
All N=52 |
Nonsquamous N=41 |
| Tumor response rate (n [%]) | 24 (52.2) | 18 (54.5) | 24 (46.2) | 16 (39.0) |
| Complete response (n [%]) | 3 (6.5) | 2 (6.1) | 2 (3.8) | 2 (4.9) |
| Partial response (n [%]) | 21 (45.7) | 16 (48.5) | 22 (42.3) | 14 (34.1) |
| Stable disease (n [%]) | 15 (32.6) | 10 (30.3) | 18 (34.6) | 17 (41.5) |
| Progressive disease (n [%]) | 1 (2.2) | 0 (0) | 6 (11.5) | 5 (12.2) |
| Unknown (n [%]) | 6 (13.0) | 5 (15.2) | 4 (7.7) | 3 (7.3) |
| Time to Event | ||||
| 2-year overall survival rate, % (95% CI) | 45.4 (29.5–60.0) | 48.0 (29.0–64.8) | 58.4 (42.6–71.3) | 55.8 (38.0–70.3) |
| Median overall survival, months (95% CI) | 18.7 (12.9-NE) | 22.8 (14.0-NE) | 27.0 (23.2-NE) | 25.9 (14.5-NE) |
| Median time-to-disease progression, months (95% CI) | 8.8 (6.0–12.6) | 9.0 (6.3–16.4) | 13.1 (8.3-NE) | 12.9 (7.8-NE). |
Abbreviations: CI=confidence interval; ITT=intent-to-treat; N=number in group; N=population size; NE=not evaluable; PC=pemetrexed/cisplatin; PCb=pemetrexed/carboplatin; RECIST=Response Evaluation in Solid Tumors.
a
Response was determined per RECIST criteria.