Table 4.
Efficacy results per blinded independent central review assessment
| Efficacy results | N1I3 Q3 (n = 50) | N3I1 Q3 (n = 49) | N3I1 Q6 (n = 49) |
|---|---|---|---|
| Overall response ratea , b | |||
| n | 16 | 15 | 15 |
| % (95% CI) | 32 (20–47) | 31 (18–45) | 31 (18–45) |
| CR | 4 (8) | 3 (6) | 0 |
| PR | 12 (24) | 12 (25) | 15 (31) |
| Overall response rate by PD‐L1 status, n/N (%)c | |||
| PD‐L1 ≥1 | 3/10 (30) | 3/10 (30) | 4/8 (50) |
| PD‐L1 <1 | 12/39 (31) | 12/38 (32) | 11/40 (28) |
| Duration of response, monthsb | |||
| Median (95% CI)d | 17.5 (8.3, NA) | 22.2 (4.4, NA) | 16.6 (4.3, NA) |
| Range | 4.6, 30.5+ | 4.2, 29.9+ | 4.1+, 32.0+ |
| DoR ≥12 months, n (%) | 9 (56) | 10 (67) | 8 (53) |
| DoR ≥24 months, n (%) | 5 (31) | 4 (27) | 5 (33) |
| Progression‐free survival, median (95% CI), monthsb | 3.9 (2.6–8.3) | 1.6 (1.4–6.9) | 2.6 (1.3–4.5) |
| OS, median (95% CI), monthsd | 22.8 (9.4, NA) | 12.5 (7.6–16.4) | 12.8 (7.4–33.0) |
Database lock: March 22, 2019; minimum follow‐up: 28.2 months.
Overall response rate (ORR) is sum of CR and PR; confidence interval based on the Clopper and Pearson method.
ORR, DoR, and PFS as assessed by blinded independent central review based on RECIST version 1.1.
PD‐L1 expression was defined as the percent of tumor cells with membrane staining in a minimum of 100 evaluable tumor cells based on the Dako PD‐L1 immunohistochemistry assay.
Kaplan‐Meier estimate.
Abbreviations: CI, confidence interval; CR, complete response; DoR, duration of response; NA, not available; N1I3 Q3, nivolumab 1 mg/kg i.v. plus ipilimumab 3 mg/kg i.v. every 3 weeks for four cycles, followed by nivolumab 240 mg i.v. every 2 weeks; N3I1 Q3, nivolumab 3 mg/kg i.v. plus ipilimumab 1 mg/kg i.v. every 3 weeks for four cycles, followed by nivolumab 240 mg i.v. every 2 weeks; N3I1 Q6, nivolumab 3 mg/kg i.v. every 2 weeks plus ipilimumab 1 mg/kg i.v. every 6 weeks; OS, overall survival; PD‐L1, programmed death‐ligand 1; PFS, progression‐free survival; PR, partial response.