Table 2.
Duration of treatment and TFIa in Japanese patients by tumor PD-L1 expression and in patients alive at 5 years (PD-L1 ≥ 1% and < 1%)
| All treated patients | PD-L1 ≥ 1% | PD-L1 < 1% | PD-L1 ≥ 1% and < 1% | |||
|---|---|---|---|---|---|---|
| Nivolumab plus ipilimumab (n = 41) |
Chemotherapy (n = 47) |
Nivolumab plus ipilimumab (n = 25) |
Chemotherapy (n = 29) |
Nivolumab plus ipilimumab (n = 66) |
Chemotherapy (n = 76) |
|
| Median duration of treatmentb, months (range) | 6.0 (0–24.0) | 4.2 (0–49.4) | 4.2 (0–24.0) | 2.3 (0–24.3) | 5.1 (0–24.0) | 3.8 (0–49.4) |
|
Median TFIc, months (95% CI) |
9.7 (4.3–32.3) | 1.8 (1.4–2.1) | 2.6 (0.9–7.7) | 1.5 (1.0–2.5) | 5.7 (2.7–10.9) | 1.7 (1.4–2.0) |
| TFIc, % (95% CI) | ||||||
| 1-year | 46 (31–61) | 11 (4–21) | 24 (10–42) | 3 (0–15) | 38 (26–49) | 8 (3–15) |
| 2-year | 39 (24–53) | 5 (1–15) | 12 (3–28) | 0 (NA–NA) | 29 (18–40) | 3 (1–10) |
| 3-year | 32 (18–46) | 5 (1–15) | 12 (3–28) | 0 (NA–NA) | 24 (15–35) | 3 (1–10) |
| Treated patients alive at 5 years | PD-L1 ≥ 1% and < 1% | |
|---|---|---|
| Nivolumab plus ipilimumab (n = 27) |
Chemotherapy (n = 20) |
|
| Median duration of treatment, months (range) | 10.7 (0–24.0) | 7.0 (2.0–49.4) |
|
Median TFIc, months (95% CI) |
NR (15.1–NR) |
2.0 (1.2–5.3) |
| TFIc, % (95% CI) | ||
| 1-year | 82 (61–92) | 15 (4–34) |
| 2-year | 63 (42–78) | 15 (4–34) |
| 3-year | 59 (39–75) | 15 (4–34) |
aTFI (defined as the time from last study dose to start of subsequent systemic therapy or death, whichever occurred first) analyses were conducted in patients who had discontinued study treatment. bMedian computed using Kaplan–Meier method. cBased on Kaplan–Meier estimates
CI confidence interval; NA not applicable; NR not reached; PD-L1 programmed death ligand 1; TFI treatment-free interval