Table 3 Summary of efficacy endpoints

From: Oncolytic DNX-2401 virotherapy plus pembrolizumab in recurrent glioblastoma: a phase 1/2 trial

Response, %

Intent-to-treat population, N = 48

Declared dose cohort, N = 42

Objective response rate (90% CI; 95% CI)

10.4% (3.5–22.3%; 4.2–20.7%)

11.9% (4.8–23.4%; 3.9–25.6%)

 CR

4.1% (0.5–14.2%; 0.7–12.5%)

4.8% (0.9–14.2%; 0.6–16.1%)

 PR

6.3% (1.3–17.1%; 1.7–15.3%)

7.1% (1.9–17.4%; 1.5–19.4%)

SD (95% CI)

45.8% (31.3–60.8%)

42.9% (27.7–59.0%)

PD (95% CI)

43.8% (29.4–58.8%)

45.2% (29.8–61.3%)

Clinical benefit rate (95% CI)

56.2% (41.1–70.5%)

54.8% (38.7–70.2%)

Survival

 12 month overall survival (95% CI)

52.7% (40.1–69.2%)

53.1% (36.8–67.0%)

 Overall survival (95% CI)

12.5 months (10.8–14.6 months)

12.5 months (10.2–13.0 months)

  1. CR denotes complete response; PR denotes partial response; SD denotes stable disease; PD denotes progressive disease. The primary efficacy endpoint was objective response rate, and the two secondary efficacy endpoints were clinical benefit rate and 12 month overall survival.