Table 2.

Efficacy endpoints.

Arm AArm BArm CArm DArm E
2L D+T2L D2L T3L D+T2L/3L D+T IFNγ+
Endpoint(n = 27)(n = 24)(n = 12)(n = 25)(n = 19)
ORR, n (%; 95% CI)2 (7.4; 0.9–24.3)0 (0; 0–14.2)1 (8.3; 0.2–38.5)1 (4.0; 0.1–20.4)3 (15.8; 3.4–39.6)
 Complete response00001 (5.3)
 Partial response2 (7.4)01 (8.3)1 (4.0)2 (10.5)
 Stable disease5 (18.5)3 (12.5)2 (16.7)6 (24.0)1 (5.3)
 Progressive disease15 (55.6)14 (58.3)5 (41.7)14 (56.0)12 (63.2)
 Nonevaluablea5 (18.5)7 (29.2)4 (33.3)4 (16.0)3 (15.8)
Ongoing response rate2 (100)NA001 (33.3)
DCR, n (%; 95% CI)7 (25.9; 11.1–46.3)3 (12.5; 2.7–32.4)3 (25.0; 5.5–57.2)7 (28.0; 12.1–49.4)4 (21.1; 6.1–45.6)
DCR24, n (%; 95% CI)2 (7.4; 0.9–24.3)0 (0; 0–14.2)3 (25.0; 5.5–57.2)3 (12.0; 2.5–31.2)3 (15.8; 3.4–39.6)
Median time to response, weeks (95% CI)16.1 (8.1–24.0)NA11.6 (NA–NA)31.1 (NA–NA)7.7 (7.3–8.0)
Median duration of response (95% CI), weeksNANA20.1 (NA–NA)32.3 (NA–NA)13.3 (8.1–NA)
Median PFS (95% CI), months1.8 (1.6–3.3)1.6 (1.0–1.8)1.7 (0.8–5.3)1.8 (1.6–3.5)1.8 (1.6–1.9)
PFS-6 (95% CI), %6.1 (0.5–22.2)NA20.0 (3.1–47.5)15.0 (4.0–32.6)NA
Median OS (95% CI), months9.2 (5.4–12.6)3.4 (1.7–4.4)7.7 (2.1–13.7)10.6 (4.8–14.8)7.0 (2.4–7.5)
OS-12 (95% CI), %37.0 (19.6–54.6)4.6 (0.3–19.0)22.9 (3.5–52.4)38.8 (19.2–58.1)NA
OS-24 (95% CI), %18.5 (6.7–34.8)0 (0–0)11.5 (0.6–39.6)9.7 (1.7–26.5)NA
  • Abbreviations: 2L, received treatment in the second-line setting; 3L, received treatment in the third-line setting; D, durvalumab; DCR, disease control rate (complete response + partial response + stable disease); DCR24, DCR at 24 weeks (complete response + partial response + stable disease ≥24 weeks); NA, not applicable; OS-12, OS rate at 12 months; OS-24, OS rate at 24 months; T, tremelimumab.

  • aNonevaluable includes patients with only a baseline assessment or a response of complete response, partial response, or stable disease at an interval of <54 days (the minimum criteria for stable disease duration) without subsequent disease evaluation and patients who had all overall response evaluations assessed as nonevaluable.