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Table 4 Efficacy results

From: Safety, tolerability, pharmacokinetics, and pharmacodynamics of the afucosylated, humanized anti-EPHA2 antibody DS-8895a: a first-in-human phase I dose escalation and dose expansion study in patients with advanced solid tumors

  Step 1 Step 1 Unknown Step 1 EPHA2 Step 1 EPHA2+ Step 1 EPHA22+ Step 1 EPHA23+ Step 2 Step 2 EPHA2 Step 2 EPHA2+ Step 2 EPHA22+ Step 2 EPHA23+
(N = 21) (N = 3) (N = 9) (N = 2) (N = 6) (N = 1) (N = 15) (N = 0) (N = 0) (N = 13) (N = 2)
  N (%) [95% CI] N (%) [95% CI] N (%) [95% CI] N (%) [95% CI] N (%) [95% CI] N (%) [95% CI] N (%) [95% CI] N (%) [95% CI] N (%) [95% CI] N (%) [95% CI] N (%) [95% CI]
Complete response 0 (0.0) [0.0–16.1] 0 (0.0) [0.0–70.8] 0 (0.0) [0.0–33.6] 0 (0.0) [0.0–84.2] 0 (0.0) [0.0–45.9] 0 (0.0) [0.0–97.5] 0 (0.0) [0.0–21.8] 0 (0.0) [n.d.] 0 (0.0) [n.d.] 0 (0.0) [0.0–24.7] 0 (0.0) [0.0–84.2]
Partial response 0 (0.0) [0.0–16.1] 0 (0.0) [0.0–70.8] 0 (0.0) [0.0–33.6] 0 (0.0) [0.0–84.2] 0 (0.0) [0.0–45.9] 0 (0.0) [0.0–97.5] 1 (6.7) [0.2–31.9] 0 (0.0) [n.d.] 0 (0.0) [n.d.] 1 (7.7) [0.2–36.0] 0 (0.0) [0.0–84.2]
Stable disease 7a (33.3) [14.6–57.0] 2 (66.7) [9.4–99.2] 3 (33.3) [7.5–70.1] 1 (50.0) [1.3–98.7] 1 (16.7) [0.4–64.1] 0 (0.0) [0.0–97.5] 6 (40.0) [16.3–67.7] 0 (0.0) [n.d.] 0 (0.0) [n.d.] 5 (38.5) [13.9–68.4] 1 (50.0) [1.3–98.7]
Progressive disease 14a (66.7) [43.0–85.4] 1 (33.3) [0.8–90.6] 6 (66.7) [29.9–92.5] 1 (50.0) [1.3–98.7] 5 (83.3) [35.9–99.6] 1 (100.0) [2.5–100.0] 8 (53.3) [26.6–78.7] 0 (0.0) [n.d.] 0 (0.0) [n.d.] 7 (53.8) [25.1–80.8] 1 (50.0) [1.3–98.7]
  1. Abbreviations: EPHA2 erythropoietin-producing hepatocellular receptor A2, CI confidence interval, n.d not determined
  2. aIncludes patients with unknown EPHA2 status