Skip to main content

Table 2 Response and outcomes in all patients and select patient subgroups

From: Avelumab in patients with previously treated metastatic melanoma: phase 1b results from the JAVELIN Solid Tumor trial

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
  1. a Patients with cutaneous or mucosal melanoma, melanoma of the canthus (n = 1), and unknown primary (n = 4)
  2. NE not estimable