Table 2

Response and disease control on the ITT population

Arm A
avelumab
N=30
Arm B
avelumab+cetuximab
N=30
Median follow-up time, months: 17.2 (IQR 15.7–18.2)
Best overall response, n (%)
CR00
PR3 (10)5 (17)
SD12 (40)12 (40)
PD15 (50)13 (43)
ORR % (two-sided 95% CI)10 (2.1–26.5)17 (5.6–34.7)
Median DOR (two-sided 95% CI), months5.5 (2.3–NE)7.6 (2.0–NE)
DCR % (two-sided 95% CI)50 (31.3–68.7)57 (37.4–74.5)
Median duration of disease control (two-sided 95% CI), months4.2 (1.8–8.6)4.6 (1.9–9.1)
Median PFS (two-sided 95% CI), months2.0 (1.8–4.0)3.9 (2.1–5.6)
Median OS (two-sided 95% CI), months12.8 (7.7–16.9)7.8 (6.2–11.2)
Updated survival
Median follow-up time, months: 26.7 (IQR 26.5–26.9)
Median PFS (two-sided 95% CI), months2.0 (1.8–4.0)3.9 (2.1–5.6)
Median OS (two-sided 95% CI), months13.9 (7.7–19.4)7.8 (6.2–11.2)
  • CR, complete response; DCR, disease control rate; DOR, duration of responses; ITT, intention to treat; NE, not estimable; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.