Response and outcomes in all patients and select patient subgroups

OutcomeAll patientsN = 51Site of primary tumorPD-L1 expression(≥1% of tumor cells)Prior ipilimumab therapy
Non-ocularan = 35Ocularn = 16Positiven = 19Negativen = 20Not evaluablen = 12Yesn = 26Non = 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), months3.1 (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), months17.2 (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)NE54.1 (27.4–74.7)NE64.8 (25.3–87.2)49.2 (28.1–67.3)NE

a Patients with cutaneous or mucosal melanoma, melanoma of the canthus (n = 1), and unknown primary (n = 4)

NE not estimable