Table 3.
Efficacy results: secondary endpoints
| Efficacy parameter | All patients (ITT) | |
|---|---|---|
| Nivolumab | Control | |
| RES population, n | 171 | 158 |
| Investigator ORR | ||
| Responders, n (%) | 33 (19.3) | 34 (21.5) |
| 95% CI | 13.7–26.0 | 15.4–28.8 |
| Odds ratio (95% CI) a | 0.88 (0.51–1.50) | |
| p value b | .6323 | |
| Investigator DoR | ||
| Median (95% CI), months | 6.93 (5.39–11.14) | 3.91 (2.79–4.17) |
| ITT population, n | 210 | 209 |
| Investigator PFS | ||
| Events, n (%) | 187 (89.0) | 176 (84.2) |
| Progression | 167 (79.5) | 162 (77.5) |
| Death | 20 (9.5) | 14 (6.7) |
| Median (95% CI), months | 1.68 (1.51–2.73) | 3.35 (2.99–4.21) |
| HR (95% CI) | 1.08 (0.87–1.34) | |
| 12‐month PFS rate (95% CI), % | 11.9 (7.8–16.8) | 7.2 (3.8–12.0) |
| 18‐month PFS rate (95% CI), % | 9.0 (5.5–13.6) | 4.0 (1.6–8.2) |
a
Stratified odds ratio.
b
p value based on stratified Cochran‐Mantel‐Haenszel test.
Abbreviations: CI, confidence interval; DoR, duration of response; HR, hazard ratio; ITT, intention‐to‐treat; ORR, overall response rate; PFS, progression‐free survival; RES, response‐evaluable set.