Table 2 Response and outcomes in all patients and select patient subgroups
Outcome | All patients N = 51 | Site of primary tumor | PD-L1 expression (≥1% of tumor cells) | Prior ipilimumab therapy | ||||
|---|---|---|---|---|---|---|---|---|
Non-oculara n = 35 | Ocular n = 16 | Positive n = 19 | Negative n = 20 | Not evaluable n = 12 | Yes n = 26 | No n = 25 | ||
ORR (95% CI), % | 21.6 (11.3–35.3) | 31.4 (16.9–49.3) | 0 (0–20.6) | 42.1 (20.3–66.5) | 0 (0–16.8) | 25.0 (5.5–57.2) | 30.8 (14.3–51.8) | 12.0 (2.5–31.2) |
PFS | ||||||||
Median (95% CI), months | 3.1 (1.4–6.3) | 3.9 (2.0–9.0) | 1.7 (1.4–4.1) | 6.3 (2.1–11.1) | 1.4 (1.3–4.1) | 3.3 (1.4-NE) | 6.3 (1.4–9.5) | 2.8 (1.4–4.1) |
6-month rate (95% CI), % | 39.2 (25.2–52.9) | 47.1 (28.7–63.4) | 23.4 (6.5–46.3) | 52.6 (28.7–71.9) | 22.4 (6.2–44.7) | 40.0 (12.3–67.0) | 50.3 (29.3–68.0) | 26.6 (10.4–46.1) |
12-month rate (95% CI), % | 17.4 (7.8–30.0) | 25.9 (11.8–42.5) | 0 (NE-NE) | 24.1 (7.8–45.1) | 0 (NE-NE) | 30.0 (7.1–57.8) | 23.3 (8.7–41.9) | 10.7 (1.9–28.3) |
OS | ||||||||
Median (95% CI), months | 17.2 (6.6-NE) | 17.2 (9.3-NE) | NE (3.6-NE) | 24.9 (6.2-NE) | 5.3 (3.8–16.2) | NE (2.1-NE) | 16.2 (5.3-NE) | 17.2 (4.7-NE) |
6-month rate (95% CI), % | 68.7 (52.9–80.2) | 75.8 (55.6–87.7) | 56.3 (29.5–76.2) | 78.9 (53.2–91.5) | 44.7 (20.5–66.5) | 88.9 (43.3–98.4) | 70.8 (48.4–84.9) | 66.9 (42.5–82.8) |
12-month rate (95% CI), % | 59.4 (43.4–72.2) | 64.9 (44.5–79.4) | 50.0 (24.5–71.0) | 68.4 (42.8–84.4) | 37.3 (14.8–60.1) | 77.8 (36.5–93.9) | 62.5 (40.3–78.4) | 56.1 (32.2–74.5) |
24-month rate (95% CI), % | 43.7 (27.3–58.9) | 44.8 (25.5–62.4) | NE | 54.1 (27.4–74.7) | NE | 64.8 (25.3–87.2) | 49.2 (28.1–67.3) | NE |