Table 3.
Study | Median OS, months [95% CI]a | Overall survival rate, % [95% CI]a |
|||
---|---|---|---|---|---|
1-year | 2-year | 3-year | 4-year | ||
CA184-008 (N = 155) | |||||
10 mg/kg, previously treated | 10.2 [7.6–16.3] | 47.2 [39.5–55.1] | 32.8 [25.4–40.5] | 23.3 [16.7–30.4] | 19.7 [13.4–26.5] |
CA184-022 (N = 217) | |||||
10 mg/kg, previously treated (n = 72) | 11.4 [6.9–16.1] | 48.6 [36.8–60.4] | 29.8 [19.1–41.1] | 24.8 [14.8–35.7] | 21.5 [11.9–32.0] |
3 mg/kg, previously treated (n = 72)b | 8.7 [6.9–12.1] | 39.3 [28.0–50.9] | 24.2 [14.4–34.8] | 19.7 [10.7–29.4] | 18.2 [9.5–27.6] |
0.3 mg/kg, previously treated (n = 73)b | 8.6 [7.7–12.7] | 39.6 [28.2–51.2] | 18.4 [9.6–28.2] | 13.8 [6.1–22.5] | 13.8 [6.1–22.5] |
CA184-007 (N = 115) | |||||
Ipilimumab–placebo (n = 57) | 19.3 [12.0–34.5] | 62.4 [49.4–75.1] | 41.8 [28.3–55.5] | 34.4 [21.1–48.2] | 32.0 [18.9–45.7] |
10 mg/kg, treatment-naïve (n = 32) | 30.5 [14.0–NR] | 71.4 [55.2–87.2] | 56.6 [38.4–74.3] | 42.5 [23.0–62.0] | 37.7 [18.6–57.4] |
10 mg/kg, previously treated (n = 25) | 14.8 [6.6–20.5] | 50.8 [31.5–71.1] | 24.2 [8.0–42.8] | 24.2 [8.0–42.8] | 24.2 [8.0–42.8] |
Ipilimumab–budesonide (n = 58) | 17.7 [6.8–45.0] | 55.9 [42.7–68.8] | 41.1 [27.7–54.8] | 38.7 [25.2–52.4] | 36.2 [22.9–49.9] |
10 mg/kg, treatment-naive (n = 21) | 45.0 [11.7–NR] | 65.9 [45.0–85.7] | 57.7 [33.3–81.0] | 57.7 [33.3–81.0] | 49.5 [23.8–75.4] |
10 mg/kg, previously treated (n = 37) | 8.5 [6.1–22.7] | 49.9 [33.3–66.6] | 31.6 [16.5–47.6] | 28.4 [13.9–44.2] | 28.4 [13.9–44.2] |
aAnalyses include all treated patients in study CA184-008 and all randomized patients in studies CA184-022 and CA184-007.
bIn the 0.3 and 3 mg/kg dose groups, 33% and 42% of patients, respectively, crossed over to the 10 mg/kg dose group.
NR, not reached.