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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