Table 2.
Median overall survival and progression-free survival rates at 3, 6, 9, 12, 18, and 24 months (Japanese ITT population)
| Nivolumab 3 mg/kg (N = 152) |
Placebo (N = 74) | |
|---|---|---|
| OS rate, % (95% CI) | ||
| At 3 months | 76.2 (68.6–82.2) | 58.9 (46.8–69.2) |
| At 6 months | 47.1 (38.9–54.8) | 34.2 (23.7–45.1) |
| At 9 months | 35.8 (28.2–43.4) | 20.5 (12.2–30.4) |
| At 12 months | 27.8 (21.0–35.1) | 15.1 (8.0–24.2) |
| At 18 months | 19.5 (13.0–27.0) | 9.0 (3.8–17.1) |
| PFS rate, % (95% CI) | ||
| At 3 months | 35.0 (27.3–42.8) | 13.9 (6.9–23.2) |
| At 6 months | 19.0 (13.0–25.9) | 6.2 (2.0–13.7) |
| At 9 months | 13.9 (8.8–20.2) | 6.2 (2.0–13.7) |
| At 12 months | 9.4 (5.2–15.0) | 3.1 (0.6–9.5) |
| At 18 months | 5.2 (2.1–10.5) | 1.5 (0.1–7.3) |
The estimation of the OS rate was derived from the Kaplan–Meier estimate and corresponding CI was derived based on Greenwood formula for variance and on log–log transformation
The estimation of the PFS rate was derived from the Kaplan–Meier estimate and corresponding CI was derived based on Greenwood formula for variance and on log–log transformation
1 month = 30.4375 days
CI Confidence interval, ITT, intention-to-treat, OS overall survival, PFS progression-free survival