Table 2.
Clinical Activity of Nivolumab in Patients With RCC
| Dose (mg/kg) | Objective Response Rate* |
Duration of Response (months)† |
Stable Disease (weeks) |
PFS (months) |
OS (months) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ≥ 24 |
≥ 48 |
||||||||||||||
| No. of Patients | % | 95% CI | Median | Individual Durations | No. of Patients | % | 95% CI | No. of Patients | % | 95% CI | Median | 95% CI | Median | 95% CI | |
| Both doses | 10 of 34 | 29.4 | 15.1 to 47.5 | 12.9 | 8.4, 9.2, 11.4, 11.4+, 12, 13, 13, 17.5+, 26.9+, 29.1+ | 9 of 34 | 26.5 | 12.9 to 44.4 | 2 of 34 | 5.9 | 0.7 to 19.7 | 7.3 | 3.6 to 10.9 | 22.4 | 12.5 to NE |
| 1 | 5 of 18 | 27.8 | 9.7 to 53.5 | 12.9 | 9.2, 11.4, 11.4+, 13, 17.5+ | 4 of 18 | 22.2 | 6.4 to 47.6 | 1 of 18 | 5.6 | 0.1 to 27.3 | 4.7 | 1.9 to 10.9 | 29.3 | 11.5 to NE |
| 10 | 5 of 16 | 31.3 | 11.0 to 58.7 | 12.9 | 8.4, 12, 13, 26.9+, 29.1+ | 5 of 16 | 31.3 | 11.0 to 58.7 | 1 of 16 | 6.3 | 0.2 to 30.2 | 8.0 | 1.7 to 14.0 | 18.8 | 11.4 to NE |
Abbreviations: CR, complete response; NE, not estimable; OS, overall survival; PFS, progression-free survival; PR, partial response; RCC, renal cell carcinoma.
*
Objective response rates were calculated based on confirmed responses: ([CR + PR]/ No.) × 100. CIs were calculated using Clopper-Pearson method. Individual patient responses were adjudicated per RECIST (version 1.0) with modification. One CR was noted (in 10-mg/kg cohort).
†
Kaplan-Meier estimate; time from first response to time of documented progression, death, or (for censored data denoted by +) time to last tumor assessment.